Energy Technology Data Exchange (ETDEWEB)
Razem, D; Katusin-Razem, B [Institut Rudjer Boskovic, Zagreb (Yugoslavia); Starcevic, M; Galekovic, B [PLIVA Pharmaceutical Works, Zagreb (Yugoslavia)
1990-01-01
The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author).
International Nuclear Information System (INIS)
Razem, D.; Katusin-Razem, B.; Starcevic, M.; Galekovic, B.
1990-01-01
The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)
2010-03-11
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...
2011-06-29
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General..., 2011, the committee will discuss current strategies for FDA's Office of Pharmaceutical Science...
2013-09-23
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... continuous manufacturing for pharmaceutical products. Speakers from the Agency, academia, and industry will...
2011-07-01
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General.... In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and...
2013-09-23
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... session, the Office of Pharmaceutical Science and the Office of Compliance will discuss with the committee...
Pharmaceutical Applications of Polymeric Nano materials
International Nuclear Information System (INIS)
Wu, L.; Sun, L.
2011-01-01
With significant attention focused on nano science and nano technology in recent years, nano materials have been used in a wide variety of applications such as automotive, environmental, energy, catalysis, biomedical, drug delivery, and polymeric industries. Among those fields, the application of nano materials with pharmaceutical science is an emerging and rapidly growing field and has drawn increasing attention recently. Research and development in this field is mainly focused on several aspects such as the discoveries of novel functional nano materials, exploration on nanoparticles with controlled and targeted drug delivery characteristics, and investigation of bio functionalized and diagnostic nano materials. In this special issue, we have invited a few papers related to recent advances in pharmaceutical application of polymeric nano materials
2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
2013-07-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
2012-07-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
2012-07-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
2012-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
2010-02-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
Ramchandren, Radhakrishnan; Schiffer, Charles A
2016-03-01
The major large US hematology-oncology meetings sponsored by the American Society of Hematology (ASH) and American Society of Clinical Oncology (ASCO) have specific guidelines in place discouraging submission of scientific information presented previously at other meetings. Nonetheless, duplicate submissions are frequent. The incidence and motivations for duplicate hematologic presentations and the influence of the pharmaceutical industry on this process have not been thoroughly analyzed. Therefore, were viewed four consecutive ASH and ASCO meetings to assess the frequency of duplicate abstract presentations. All abstracts presented at ASCO2010 in the area of malignant hematology were compared with abstracts from ASCO and ASH 2009 and ASH 2010, and funding sources were reviewed. More than half (54%) of all abstracts submitted to ASCO 2010 acknowledged pharmaceutical company support. Almost one third (31%) of ASCO 2010 abstracts were resubmitted in the 2-year time period, and it was notable that a high fraction (75%) of these duplicate abstracts had pharmaceutical industry sponsorship, compared with 42% of the abstracts that were submitted only once. Despite current guidelines prohibiting duplicate abstract presentation, a substantial proportion (31%) of abstracts at large international hematology-oncology meetings are duplicative, with potential negative consequences. In addition, a disproportionate percentage of the duplicate abstracts rely on pharmaceutical industry support (75%), suggesting that marketing strategies may be a motivation for some of these repetitive submissions.
Prescribers and pharmaceutical representatives: why are we still meeting?
Fischer, Melissa A; Keough, Mary Ellen; Baril, Joann L; Saccoccio, Laura; Mazor, Kathleen M; Ladd, Elissa; Von Worley, Ann; Gurwitz, Jerry H
2009-07-01
Research suggests that pharmaceutical marketing influences prescribing and may cause cognitive dissonance for prescribers. This work has primarily been with physicians and physician-trainees. Questions remain regarding why prescribers continue to meet with pharmaceutical representatives (PRs). To describe the reasons that prescribers from various health professions continue to interact with PRs despite growing evidence of the influence of these interactions. Multi-disciplinary focus groups with 61 participants held in practice settings and at society meetings. Most prescribers participating in our focus groups believe that overall PR interactions are beneficial to patient care and practice health. They either trust the information from PRs or feel that they are equipped to evaluate it independently. Despite acknowledgement of study findings to the contrary, prescribers state that they are able to effectively manage PR interactions such that their own prescribing is not adversely impacted. Prescribers describe few specific strategies or policies for these interactions, and report that policies are not consistently implemented with all members of a clinic or institution. Some prescribers perceive an inherent contradiction between academic centers and national societies receiving money from pharmaceutical companies, and then recommending restriction at the level of the individual prescriber. Prescribers with different training backgrounds present a few novel reasons for these meetings. Despite evidence that PR detailing influences prescribing, providers from several health professions continue to believe that PR interactions improve patient care, and that they can adequately evaluate and filter information presented to them by PRs. Focus group comments suggest that cultural change is necessary to break the norms that exist in many settings. Applying policies consistently, considering non-physician members of the healthcare team, working with trainees, restructuring
Materials science tetrahedron--a useful tool for pharmaceutical research and development.
Sun, Changquan Calvin
2009-05-01
The concept of materials science tetrahedron (MST) concisely depicts the inter-dependent relationship among the structure, properties, performance, and processing of a drug. Similar to its role in traditional materials science, MST encompasses the development in the emerging field of pharmaceutical materials science and forms a scientific foundation to the design and development of new drug products. Examples are given to demonstrate the applicability of MST to both pharmaceutical research and product development. It is proposed that a systematic implementation of MST can expedite the transformation of pharmaceutical product development from an art to a science. By following the principle of MST, integration of research among different laboratories can be attained. The pharmaceutical science community as a whole can conduct more efficient, collaborative, and coherent research.
International Nuclear Information System (INIS)
2005-01-01
Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation
Energy Technology Data Exchange (ETDEWEB)
NONE
2005-07-01
Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation
Thermodynamics of water-solid interactions in crystalline and amorphous pharmaceutical materials.
Sacchetti, Mark
2014-09-01
Pharmaceutical materials, crystalline and amorphous, sorb water from the atmosphere, which affects critical factors in the development of drugs, such as the selection of drug substance crystal form, compatibility with excipients, dosage form selection, packaging, and product shelf-life. It is common practice to quantify the amount of water that a material sorbs at a given relative humidity (RH), but the results alone provide minimal to no physicochemical insight into water-solid interactions, without which pharmaceutical scientists cannot develop an understanding of their materials, so as to anticipate and circumvent potential problems. This research was conducted to advance the science of pharmaceutical materials by examining the thermodynamics of solids with sorbed water. The compounds studied include nonhygroscopic drugs, a channel hydrate drug, a stoichiometric hydrate excipient, and an amorphous excipient. The water sorption isotherms were measured over a range of temperature to extract the partial molar enthalpy and entropy of sorbed water as well as the same quantities for some of the solids. It was found that water-solid interactions spanned a range of energy and entropy as a function of RH, which was unique to the solid, and which could be valuable in identifying batch-to-batch differences and effects of processing in material performance. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.
Bowman, M
2015-02-01
The Generic Pharmaceutical Association (GPhA) chairman Craig Wheeler (Momenta Pharmaceuticals), welcomed attendees to the 2015 Annual Meeting by reflecting on the contributions of the generic industry over the past year and some of the challenges that lie ahead. In 2014, 86% of prescriptions dispensed in the U.S. were generic, contributing to the USD 1.4 trillion savings generated by the industry since its inception; however, there are still many challenges to face, including consolidation of customers, lag in Abbreviated New Drug Application (ANDA) approval timelines, restrictive Risk Evaluation and Mitigation Strategy (REMS) programs and labeling legislations. The continued drive into the branded business by many GPhA member companies has resulted in the association planning a structural division for companies involved in biologic and biosimilar products. During the 3-day meeting, attendees listened to expert panels discuss major business, regulatory and market trends developing in the generic industry, with insights from the U.S. Food and Drug Administration (FDA) and market analysts. The meeting also provided attendees with numerous opportunities to socialize and network with key decision makers in the industry. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.
Directory of Open Access Journals (Sweden)
Basavaiah Kanakapura
2016-06-01
Full Text Available Terbinafine is a new powerful antifungal agent indicated for both oral and topical treatment of mycosessince. It is highly effective in the treatment of determatomycoses. The chemical and pharmaceutical analysis of the drug requires effective analytical methods for quality control and pharmacodynamic and pharmacokinetic studies. Ever since it was introduced as an effective antifungal agent, many methods have been developed and validated for its assay in pharmaceuticals and biological materials. This article reviews the various methods reported during the last 25 years.
Stauffer, F; Vanhoorne, V; Pilcer, G; Chavez, P-F; Rome, S; Schubert, M A; Aerts, L; De Beer, T
2018-06-01
Active Pharmaceutical Ingredients (API) raw material variability is not always thoroughly considered during pharmaceutical process development, mainly due to low quantities of drug substance available. However, synthesis, crystallization routes and production sites evolve during product development and product life cycle leading to changes in physical material attributes which can potentially affect their processability. Recent literature highlights the need for a global approach to understand the link between material synthesis, material variability, process and product quality. The study described in this article aims at explaining the raw material variability of an API using extensive material characterization on a restricted number of representative batches using multivariate data analysis. It is part of a larger investigation trying to link the API drug substance manufacturing process, the resulting physical API raw material attributes and the drug product continuous manufacturing process. Eight API batches produced using different synthetic routes, crystallization, drying, delumping processes and processing equipment were characterized, extensively. Seventeen properties from seven characterization techniques were retained for further analysis using Principal Component Analysis (PCA). Three principal components (PCs) were sufficient to explain 92.9% of the API raw material variability. The first PC was related to crystal length, agglomerate size and fraction, flowability and electrostatic charging. The second PC was driven by the span of the particle size distribution and the agglomerates strength. The third PC was related to surface energy. Additionally, the PCA allowed to summarize the API batch-to-batch variability in only three PCs which can be used in future drug product development studies to quantitatively evaluate the impact of the API raw material variability upon the drug product process. The approach described in this article could be applied to any
Buckner, Ira S; Friedman, Ross A; Wurster, Dale Eric
2010-02-01
The process by which pharmaceutical powders are compressed into cohesive compacts or tablets has been studied using a compression calorimeter. Relating the various thermodynamic results to relevant physical processes has been emphasized. Work, heat, and internal energy change values have been determined with the compression calorimeter for common pharmaceutical materials. A framework of equations has been proposed relating the physical processes of friction, reversible deformation, irreversible deformation, and inter-particle bonding to the compression calorimetry values. The results indicate that irreversible deformation dominated many of the thermodynamic values, especially the net internal energy change following the compression-decompression cycle. The relationships between the net work and the net heat from the complete cycle were very clear indicators of predominating deformation mechanisms. Likewise, the ratio of energy stored as internal energy to the initial work input distinguished the materials according to their brittle or plastic deformation tendencies. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association.
International Nuclear Information System (INIS)
Toelgyessy, J.
2001-09-01
The publication has been set up as the abstracts of the meeting dealing with different chemical problems. The book (Vol. 3) consists of the sections: (F) Chemistry of polymers, organic materials, textile, fibres, foil materials (63 papers); (I) Organic and pharmaceutical chemistry (59 papers); (J) Food chemistry and biotechnology (26 papers); (M) Environment, Toxicology (51 papers)
Lewen, Nancy
2011-06-25
The subject of the analysis of various elements, including metals and metalloids, in the pharmaceutical industry has seen increasing importance in the last 10-15 years, as modern analytical instrumentation has afforded analysts with the opportunity to provide element-specific, accurate and meaningful information related to pharmaceutical products. Armed with toxicological data, compendial and regulatory agencies have revisited traditional approaches to the testing of pharmaceuticals for metals and metalloids, and analysts have begun to employ the techniques of atomic spectroscopy, such as flame- and graphite furnace atomic absorption spectroscopy (FAAS, Flame AA or FAA and GFAAS), inductively coupled plasma-atomic emission spectroscopy (ICP-AES) and inductively coupled plasma-mass spectrometry (ICP-MS), to meet their analytical needs. Newer techniques, such as laser-induced breakdown spectroscopy (LIBS) and Laser Ablation ICP-MS (LAICP-MS) are also beginning to see wider applications in the analysis of elements in the pharmaceutical industry.This article will provide a perspective regarding the various applications of atomic spectroscopy in the analysis of metals and metalloids in drug products, active pharmaceutical ingredients (API's), raw materials and intermediates. The application of atomic spectroscopy in the analysis of metals and metalloids in clinical samples, nutraceutical, metabolism and pharmacokinetic samples will not be addressed in this work. Copyright © 2010 Elsevier B.V. All rights reserved.
Removal of Pharmaceutical Compounds from Hospital Wastewaters Using Nanomaterials: A Review
Directory of Open Access Journals (Sweden)
Hasan Bagheri
2016-06-01
Full Text Available Over the past few years, residual pharmaceuticals (antibiotics, anticonvulsants, antipyretics drugs, hormones have begun to be considered as emerging environmental pollutants due to their continuous input and persistence to aquatic ecosystem even at low concentrations. Therefore, the development of efficient, cost-effective, and stable methods and materials for the wastewaters treatment have gained more recognition in recent years. In the path of meeting these developments, nanomaterials have attracted much attention as economical, convenient and ecofriendly tools for removing of pharmaceuticals from the hospital wastewaters because of their unique properties. The present review deals with recent advances in removal and/or destruction of residual pharmaceutical in wastewater samples using nanomaterials including metal nanoparticles, carbon nanotubes and nanofilters. In spite of using a variety of nanomaterials to remove the residual of pharmaceuticals, there is still a dearth of successful applicability of them in industrial processes. Therefore, some defects of nanomaterials to be used for the removal of pharmaceutical contaminate in environmental samples and their impacts on human health and environment is briefly discussed.
[The 10th Annual Meeting of the Japanese Society for Pharmaceutical Palliative Care and Sciences].
Shiokawa, Mitsuru; Kawamura, Kazumi
2018-01-01
The 10th Annual Meeting of the Japanese Society for Pharmaceutical Palliative Care and Sciences was held at Act City Hamamatsu, Japan, with a total of 2634 participants in attendance. The theme of the meeting was realized through a number of new concepts, such as a debate symposium, information sessions, nurses' workshops, and so on. The results obtained from the participation questionnaire (n=438), which were aggregated up to 1 month following the end of this year's meeting, revealed that 89% of the participants at considered it to have been appealing. In particular, 63% of the participants favored the adoption of a debate symposium whereby it was possible to ask and respond to questions in real time. In the free comments section of the questionnaire, the participants expressed how they felt the debate symposium made it easy to give their opinions, and that this element might be further developed in the future. They also stated that they found the introduction of the Clica system effective in terms of making the annual meeting an active learning place. One issue that was highlighted concerned the observation that the hall used to host the symposium was designed as a concert venue, which meant it was highly shielded from the outside environment, in addition to access to the internet being blocked. I hope that many of the projects from this Annual Meeting will serve to guide the future style of the Society's Annual Meetings.
Jenke, Dennis; Couch, Tom; Gillum, Amy
2010-01-01
Material/water equilibrium binding constants (E(b)) were determined for 11 organic solutes and 2 plastic materials commonly used in pharmaceutical product containers (plasticized polyvinyl chloride and polyolefin). In general, solute binding by the plasticized polyvinyl chloride material was greater, by nearly an order of magnitude, than the binding by the polyolefin (on an equal weight basis). The utilization of the binding constants to facilitate container compatibility assessments (e.g., drug loss by container binding) for drug-containing products is discussed.
Container-content compatibility studies: a pharmaceutical team's integrated approach.
Laschi, Alda; Sehnal, Natacha; Alarcon, Antoine; Barcelo, Beatrice; Caire-Maurisier, François; Delaire, Myriam; Feuilloley, Marc; Genot, Stéphanie; Lacaze, Catherine; Pisarik, Luc; Smati, Christophe
2009-01-01
Container-content compatibility studies are required as part of the submission of a new product market authorization file or for a change relating to the primary product-contact packaging. Many regulatory publications and guidances are available in the USA, Europe, and Japan. However these publications and guidances are not sufficiently precise enough to allow for consistent interpretation and implementation of the technical requirements. A working group has been formed by the French Society of Pharmaceutical Science and Technology (SFSTP) in order to propose guidance for container-content interaction studies that meet both European and US requirements, and allows consistent and standardized information to be presented by the industry to the regulators. When a pharmaceutical drug product remains in prolonged contact with a material, the two critical points to consider are the drug product's quality and safety. A pharmaceutical evaluation of the container-content relationship should be done based on the knowledge of the contact material (e.g., type, physicochemical properties), its manufacturing processes (e.g., the type of sterilization that could potentially alter the interactions), and the formulation components involved in contact with this material (e.g., physicochemical properties, pharmaceutical presentation, route of administration). Quality is evaluated using the stability study performed on the product. Safety is partially evaluated with the stability study and is analyzed in conjunction with toxicity testing, specifically with cytotoxicity testing. The toxicity aspect is the key point of the container-content compatibility study and of patient safety. Migration tests are conducted when an interaction is suspected, or found based on previous results, to identify the component responsible for this interaction and to help select a new material if needed. Therefore, such tests are perhaps not the best ones to use for the purpose of safety evaluation
Adhesion of Pharmaceutical Binding Agents I-Adhesion to polymeric materials
Directory of Open Access Journals (Sweden)
Hossain Orafai
1996-08-01
Full Text Available Adhesion of three commonly used pharmaceutical binding agents, HPMC , PVP and Gelatin to five different polymeric sheet materials was studied. After conditioning, the bond strength of the specimens were measured by shear testing method using a suitablely designed apparatus. The results were correlated to the surface energies and the solubiiity parameters of the adherends. It is concluded that the thermodynamic properties and the solubility parameters are dominant when the mechanisms of adhesion are by adsorption and diffusion respectively.
National Research Council Canada - National Science Library
Clarke, E. G. C; Moffat, A. C; Jackson, J. V
1986-01-01
This book is intended for scientists faced with the difficult problem of identifying an unknown drug in a pharmaceutical product, in a sample of tissue or body fluid from a living patient, or in post-mortem material...
Sun, Lan; Hsiung, Chang; Pederson, Christopher G.; Zou, Peng; Smith, Valton; von Gunten, Marc; O?Brien, Nada A.
2016-01-01
Near-infrared spectroscopy as a rapid and non-destructive analytical technique offers great advantages for pharmaceutical raw material identification (RMID) to fulfill the quality and safety requirements in pharmaceutical industry. In this study, we demonstrated the use of portable miniature near-infrared (MicroNIR) spectrometers for NIR-based pharmaceutical RMID and solved two challenges in this area, model transferability and large-scale classification, with the aid of support vector machin...
International Nuclear Information System (INIS)
Uher, M.; Benes, P.; Carsky, J.; Ctrnactova, H.; Fecenko, J.; Fellner, P.; Hodul, P.; Koprda, V.; Kratochvil, B.; Krkoska, P.; Kuruc, J.; Lehotay, J.; Matousek, J.; Milichovsky, P.; Omastova, M.; Petrus, L. jr.; Petrus, L. sr.; Schwendt, P.; Silny, P.; Sevcik, P.; Toma, S.; Uherova, R.; Zachar, P.
1999-09-01
The publication has been set up as an abstracts of the meeting dealing with different chemical problems. The book (Vol. 3) consists of the sections: (E) Wood, pulp, paper (15 papers); (G) Macromolecular chemistry (42 papers); (H) Organic chemistry, bio-organic chemistry and pharmaceutical chemistry (96 Papers); (I) Food chemistry and biochemistry; (J) Textile, fibres and foil materials
37. annual meeting of the Institute of Nuclear Materials Management
International Nuclear Information System (INIS)
Anon.
1996-01-01
The following subjects were covered in this meeting: waste management; nuclear materials management -- safety and health; international safeguards; measurement control and statistics for nuclear materials management; material control and accountability; packaging and transportation; nonproliferation and arms control; and physical protection. Separate papers were prepared for 74 items of this meeting
Directory of Open Access Journals (Sweden)
Jianyi Zhang
2017-07-01
Full Text Available As one of the commonly-used solid dosage forms, pharmaceutical tablets have been widely used to deliver active drugs into the human body, satisfying patient’s therapeutic requirements. To manufacture tablets of good quality, diluent powders are generally used in formulation development to increase the bulk of formulations and to bind other inactive ingredients with the active pharmaceutical ingredients (APIs. For formulations of a low API dose, the drug products generally consist of a large fraction of diluent powders. Hence, the attributes of diluents become extremely important and can significantly influence the final product property. Therefore, it is essential to accurately characterise the mechanical properties of the diluents and to thoroughly understand how their mechanical properties affect the manufacturing performance and properties of the final products, which will build a sound scientific basis for formulation design and product development. In this study, a comprehensive evaluation of the mechanical properties of the widely-used pharmaceutical diluent powders, including microcrystalline cellulose (MCC powders with different grades (i.e., Avicel PH 101, Avicel PH 102, and DG, mannitol SD 100, lactose monohydrate, and dibasic calcium phosphate, were performed. The powder compressibility was assessed with Heckel and Kawakita analyses. The material elastic recovery during decompression and in storage was investigated through monitoring the change in the dimensions of the compressed tablets over time. The powder hygroscopicity was also evaluated to examine the water absorption ability of powders from the surroundings. It was shown that the MCC tablets exhibited continuous volume expansion after ejection, which is believed to be induced by (1 water absorption from the surrounding, and (2 elastic recovery. However, mannitol tablets showed volume expansion immediately after ejection, followed by the material shrinkage in storage. It is
Stults, Cheryl L. M.; Ansell, Jennifer M.; Shaw, Arthur J.; Nagao, Lee M.
2014-01-01
Polymeric materials are often used in pharmaceutical packaging, delivery systems, and manufacturing components. There is continued concern that chemical entities from polymeric components may leach into various dosage forms, particularly those that are comprised of liquids such as parenterals, injectables, ophthalmics, and inhalation products. In some cases, polymeric components are subjected to routine extractables testing as a control measure. To reduce the risk of discovering leachables du...
Faustino, Ce´lia; Bettencourt, Ana F.; Alfaia, Anto´nio; Pinheiro, Lídia
2015-01-01
Rheological measurements are very important tools for the characterization of the flow and deformation of a material, as well as for optimization of the rheological parameters. The application and acceptance of pharmaceutical formulations, cosmetics, and foodstuffs depends upon their rheological characteristics, such as texture, consistency, or…
Meeting the regulatory information needs of users of radioactive materials
International Nuclear Information System (INIS)
MacDurmon, G.W.
1996-01-01
The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff
Meeting the regulatory information needs of users of radioactive materials
Energy Technology Data Exchange (ETDEWEB)
MacDurmon, G.W. [American Cyanamid Company, Princeton, NJ (United States)
1996-10-01
The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff.
Technical meeting on materials for in-vessel components of ITER
International Nuclear Information System (INIS)
Kalinin, G.; Barabash, V.
2000-01-01
The Technical meeting on materials for in-vessel components of ITER was held at the ITER Joint Work Site in Garching from 31 January to 4 February. The main objectives of the meetings were: 1. to summarize the requirements, 2. to review new data, 3. to discuss in detail the R and D program and to discuss the material assessment report
2012-03-20
..., Notice of Registration; Johnson Matthey Pharmaceutical Materials Inc. By Notice dated November 18, 2011... Pharmaceutical Materials Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts 01434, made... Matthey Pharmaceutical Materials Inc. to manufacture the listed basic classes of controlled substances is...
Sun, Lan; Hsiung, Chang; Pederson, Christopher G; Zou, Peng; Smith, Valton; von Gunten, Marc; O'Brien, Nada A
2016-05-01
Near-infrared spectroscopy as a rapid and non-destructive analytical technique offers great advantages for pharmaceutical raw material identification (RMID) to fulfill the quality and safety requirements in pharmaceutical industry. In this study, we demonstrated the use of portable miniature near-infrared (MicroNIR) spectrometers for NIR-based pharmaceutical RMID and solved two challenges in this area, model transferability and large-scale classification, with the aid of support vector machine (SVM) modeling. We used a set of 19 pharmaceutical compounds including various active pharmaceutical ingredients (APIs) and excipients and six MicroNIR spectrometers to test model transferability. For the test of large-scale classification, we used another set of 253 pharmaceutical compounds comprised of both chemically and physically different APIs and excipients. We compared SVM with conventional chemometric modeling techniques, including soft independent modeling of class analogy, partial least squares discriminant analysis, linear discriminant analysis, and quadratic discriminant analysis. Support vector machine modeling using a linear kernel, especially when combined with a hierarchical scheme, exhibited excellent performance in both model transferability and large-scale classification. Hence, ultra-compact, portable and robust MicroNIR spectrometers coupled with SVM modeling can make on-site and in situ pharmaceutical RMID for large-volume applications highly achievable. © The Author(s) 2016.
Colorimetric determination of a paracetamole in raw material and in pharmaceutical dosage forms
International Nuclear Information System (INIS)
Usifoh, C.O; Adelusi, S.A.; Adebambo, R.F.
2002-01-01
A rapid, accurate and simple method is proposed for the determination of p-acetaminophen (paracetamole) in raw material, tablets and syrups. The method is based on measuring the intensity of the yellow color that developed when acute acetaminophen is allowed to react with p-dimethylaminobenzaldehyde in 2M HCl after heating. The color which absorbs in the visible region of gamma 450 nm is stable for several hours and the intensity is directly proportional to the concentration of the drug, that is, Beer lambert law is obeyed. The method can be used to analyse paracetamole in raw material and in pharmaceutical dosage forms. (author)
78 FR 65265 - Materials Technical Advisory Committee; Notice of Open Meeting
2013-10-31
.... Report on regime-based activities. 7. SHUTDOWN Feedback. 8. Public Comments and New Business. The open...; Notice of Open Meeting The Materials Technical Advisory Committee will meet on November 14, 2013, 10:00 a... materials and related technology. Agenda Open Session 1. Opening Remarks and Introductions. 2. Remarks from...
Higashi, Taishi; Iohara, Daisuke; Motoyama, Keiichi; Arima, Hidetoshi
2018-01-01
Supramolecular chemistry is an extremely useful and important domain for understanding pharmaceutical sciences because various physiological reactions and drug activities are based on supramolecular chemistry. However, it is not a major domain in the pharmaceutical field. In this review, we propose a new concept in pharmaceutical sciences termed "supramolecular pharmaceutical sciences," which combines pharmaceutical sciences and supramolecular chemistry. This concept could be useful for developing new ideas, methods, hypotheses, strategies, materials, and mechanisms in pharmaceutical sciences. Herein, we focus on cyclodextrin (CyD)-based supermolecules, because CyDs have been used not only as pharmaceutical excipients or active pharmaceutical ingredients but also as components of supermolecules.
Pharmaceutical cocrystals:formation mechanisms, solubility behaviour and solid-state properties
Alhalaweh, Amjad
2012-01-01
The primary aim of pharmaceutical materials engineering is the successful formulation and process development of pharmaceutical products. The diversity of solid forms available offers attractive opportunities for tailoring material properties. In this context, pharmaceutical cocrystals, multicomponent crystalline materials with definite stoichiometries often stabilised by hydrogen bonding, have recently emerged as interesting alternative solid forms with potential for improving the physical a...
Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients
DEFF Research Database (Denmark)
Malwade, Chandrakant Ramkrishna; Qu, Haiyan
2018-01-01
Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing of Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities...... parameters and their impact on quality of APIs and subsequently the drug products assume great significance for pharmaceutical industry. Methods: This review paper focuses on application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design...
Materials Characterization Center meeting on impact testing of waste forms. Summary report
International Nuclear Information System (INIS)
Merz, M.D.; Atteridge, D.; Dudder, G.
1981-10-01
A meeting was held on March 25-26, 1981 to discuss impact test methods for waste form materials to be used in nuclear waste repositories. The purpose of the meeting was to obtain guidance for the Materials Characterization Center (MCC) in preparing the MCC-10 Impact Test Method to be approved by the Materials Review Board. The meeting focused on two essential aspects of the test method, namely the mechanical process, or impact, used to effect rapid fracture of a waste form and the analysis technique(s) used to characterize particulates generated by the impact
Energy Technology Data Exchange (ETDEWEB)
NONE
1977-07-01
The Specialists Meeting on Properties of Primary Circuit Structural Materials of LMFBRs covered the following topics: overview of materials program in different countries; mechanical properties of materials in air; fracture mechanics studies - component related activities; impact of environmental influences on mechanical properties; relationship of material properties and design methods. The purpose of the meeting was to provide a forum for exchange of information on structural materials behaviour in primary circuit of fast breeder reactors. Special emphasis was placed on environmental effects such as influence of sodium and irradiation on mechanical properties of reactor materials.
International Nuclear Information System (INIS)
1977-01-01
The Specialists Meeting on Properties of Primary Circuit Structural Materials of LMFBRs covered the following topics: overview of materials program in different countries; mechanical properties of materials in air; fracture mechanics studies - component related activities; impact of environmental influences on mechanical properties; relationship of material properties and design methods. The purpose of the meeting was to provide a forum for exchange of information on structural materials behaviour in primary circuit of fast breeder reactors. Special emphasis was placed on environmental effects such as influence of sodium and irradiation on mechanical properties of reactor materials
Here are materials for the OECD Working Party on Nanomanufactured Materials Expert Meeting on Categorization of Nanomaterials (developing nanomaterial categories) took place on September 17-19, 2014 in Washington, D.C hosted by U.S. EPA.
2017-10-01
Preface Dear ladies and gentlemen, On 6th and 7th of April 2017 took place the “International Materials Research Meeting in the Greater Region” at the Saarland University, Saarbrücken, Germany. This meeting corresponded to the 9th EEIGM International Conference on Advanced Materials Research and it was intended as a meeting place for researchers of the Greater Region as well as their partners of the different cooperation activities, like the EEIGM program, the ‘Erasmus Mundus’ Advanced Materials Science and Engineering Master program (AMASE), the ‘Erasmus Mundus’ Doctoral Program in Materials Science and Engineering (DocMASE) and the CREATe-Network. On this meeting, 72 participants from 15 countries and 24 institutions discussed and exchanged ideas on the latest trends in the characterization of materials and surface modifications. Different aspects of the material research of metals, ceramics, polymers and biomaterials were presented. As a conclusion of the meeting, the new astronaut of the European Space Agency Dr. Matthias Maurer, who is an alumni of the Saarland University and the EEIGM, held an exciting presentation about his activities. Following the publication of selected papers of the 2009 meeting in Volume 5 and 2012 meeting in Volume 31 of this journal, it is a great pleasure to present this selection of 9 articles to the readers of the IOP Conference Series: Materials Science and Engineering. The editors are thankful to all of the reviewers for reviewing the papers. Special praise is also given to the sponsors of the conference: European Commission within the program Erasmus Mundus (AMASE and DocMASE), Erasmus+ (AMASE), and Horizon2020 (CREATe-Network, Grant agreement No 644013): the DAAD (Alumni Program), and the German-French University (PhD-Track). List of Author signatures, Conference topics, Organization, Conference impressions and list of the participants are available in this PDF.
Meeting Local Needs in Materials Writing
Directory of Open Access Journals (Sweden)
Rahma Al-Mahrooqi
2010-01-01
Full Text Available Textbooks are viewed as an essential tool in ELT. Despite the abundance of commercial textbooks, very few of them seem to meet the local needs of students and teachers in a certain context, owing to certain pitfalls in the materials. When a program adopts a certain commercial textbook the teachers soon realize that they have to supplement the materials to bridge the gap between what these materials offer and the local needs. Sometimes the supplementation yields greater volumes of materials than the book itself, causing teachers and learners to lose focus. An added complexity is the fact that there are always new, more attractive titles in the market, leaving the program in a dilemma of whether to keep their old, well supplemented textbooks or to replace them with new ones and start another cycle of supplementation. The ideal solution is for a program to produce its own teaching materials. However, writing quality local materials that can compete with commercial ones can be a real challenge. It requires clear vision, creativity, commitment and team work.
Dutra, Flávia Viana Avelar; Pires, Bruna Carneiro; Nascimento, Tienne Aparecida; Borges, Keyller Bastos
2018-09-01
The composite polyaniline/multiwalled carbon nanotube (PAni/MWCNT, 1:0.1 w/w) was developed with the intention of binding the adsorbent properties of two materials and using it to adsorb pharmaceuticals from aqueous media. PAni/MWCNT was characterized by scanning electron microscopy, thermogravimetry, infrared spectroscopy, pH at the point of zero charge, and the effect on the surface wettability of the material. As proof of concept, adsorption studies were carried out using meloxicam (MLX) as the pharmaceutical and it was evaluated as a function of pH, temperature, ionic strength, contact time and variation in concentration. Kinetics and isothermal models were applied to evaluate the mechanism of the adsorption process. The best MLX adsorption result was at pH 2 with 6 min of contact with PAni/MWCNT. The kinetics models that fitted the experimental data were pseudo-second order and Elovich and the kinetics model was the dual-site Langmuir-Freundlich. Both models suggest that the adsorption occurs by the chemical nature of the surface and in the pores of the energetically heterogeneous composite. The PAni/MWCNT presented an adsorption capacity of 221.2 mg g -1 , a very good value when compared with the literature and can be used to remove pharmaceuticals from aqueous environments. Copyright © 2018 Elsevier Ltd. All rights reserved.
Marketing concepts for pharmaceutical service development.
Grauer, D W
1981-02-01
Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.
Kibble, A; D'Souza, P
2015-10-01
Translating perceived market value for pharmaceutical products into a willingness to pay remains the key factor in ensuring market access and return on investment. How price is managed in the context of new market entrants or new approval settings can create complex challenges, and further complexity is added through diverse global reimbursement structures and the myriad of stakeholders involved at every step of value identification. SMi's 21st Annual Meeting on European Pricing and Reimbursement presented a program focused on the measures being taken by European healthcare systems as they seek to facilitate access to the latest treatments while delivering value for payers and patients. Supporting patient access to life-changing medicines is a challenge, and funders are responding in many different ways; however, while the pharma industry continues to focus its efforts on high cost drugs that treat diseases of the few, the disconnect will be not be resolved. The speakers and delegates at the annual meeting believe success is possible by focusing on value for patients, driven by provider experience, scale and learning. Instead of simply lowering costs, companies, providers and payers can more adequately contribute to the goals of funders as well as the treatment needs of patients. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.
2013-03-28
... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Johnson Matthey Pharmaceutical Materials, Inc. Pursuant to Sec. 1301.33(a), Title... Matthey Pharmaceutical Materials, Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts...
Butler, Owen; Forder, James; Saunders, John
2015-03-15
Workers in the pharmaceutical industry can potentially be exposed to airborne dusts and powders that can contain potent active pharmaceutical ingredients (API). Occupational hygienists and health and safety professionals need to assess and ultimately minimise such inhalation and dermal exposure risks. Containment of dusts at source is the first line of defence but the performance of such technologies needs to be verified, for which purpose the good practice guide: assessing the particulate containment performance of pharmaceutical equipment, produced by the International Society for Pharmaceutical Engineering (ISPE), is a widely used reference document. This guide recommends the use of surrogate powders that can be used to challenge the performance of such containment systems. Materials such as lactose and mannitol are recommended as their physical properties (adhesion, compactability, dustiness, flow characteristics and particle sizes) mimic those of API-containing materials typically handled. Furthermore they are safe materials to use, are available in high purity and can be procured at a reasonable cost. The aim of this work was to develop and validate a sensitive ion-chromatography based analytical procedure for the determination of surrogate powders collected on filter samples so as to meet analytical requirements set out in this ISPE guide. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.
Jenke, Dennis; Couch, Tom; Gillum, Amy; Sadain, Salma
2009-01-01
Material/water equilibrium binding constants (Eb) were determined for 14 organic solutes and 17 plastic raw materials that could be used in pharmaceutical product container systems. Correlations between the measured binding constants and the organic solute's octanol/water and hexane/water partition coefficients were obtained. In general, while the materials examined exhibited a wide range of binding characteristics, the tested materials by and large fell within two broad classes: (1) those that were octanol-like in their binding characteristics, and (2) those that were hexane-like. Materials of the same class (e.g., polypropylenes) generally had binding models that were very similar. Rank ordering of the materials in terms of their magnitude of drug binding (least binding to most binding) was as follows: polypropylene < polyethylene < polyamide < styrene-ethylene-butylene-styrene < copolyester ether elastomer approximately equal to amine-terminated poly fatty acid amide polymer. The utilization of the developed models to estimate drug loss via sorption by the container is discussed.
ASTM and ASME-BPE Standards--Complying with the Needs of the Pharmaceutical Industry.
Huitt, William M
2011-01-01
Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and standards and then modifying them in order to meet the more stringent requirements of the Food and Drug Administration (FDA). In 1997 the American Society of Mechanical Engineers (ASME) published the first Bioprocessing Equipment (BPE) Standard. Through harmonization efforts this relatively new standard has brought together, scrutinized, and refined industry accepted methodologies together with FDA compliance requirements, and has established an American National Standard that provides a comprehensive set of standards that are integral to the pharmaceutical industry. This article describes various American National Standards, including those developed and published by the American Society for Testing and Materials (ASTM), and how they apply to the pharmaceutical industry. It goes on to discuss the harmonization effort that takes place between the various standards developers in an attempt to prevent conflicts and omissions between the many standards. Also included are examples of tables and figures taken from the ASME-BPE Standard. These examples provide the reader with insight to the relevant content of the ASME-BPE Standard. Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and
Microbiological quality of pharmaceutical products in Bangladesh: current research perspective
Rashed Noor; Nagma Zerin; Kamal Kanta Das
2015-01-01
Pharmaceutical industrialization in Bangladesh, both by multinational and local companies, has increased significantly in the last two decades. Most of the pharmaceutical products are found to be therapeutically competent to meet the demands of general population satisfactorily. However, complaints regarding the compromised quality of the products stored in markets are also reported very often. In order to ensure the overall drug user safety, the present review discussed the pr...
2013-07-31
...; Notice of Registration; Johnson Matthey Pharmaceutical Materials, Inc. By Notice dated March 20, 2013, and published in the Federal Register on March 28, 2013, 78 FR 19017, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Services, 25 Patton Road, Devens, Massachusetts 01434, made application by...
Mixed Reality Meets Pharmaceutical Development.
Forrest, William P; Mackey, Megan A; Shah, Vivek M; Hassell, Kerry M; Shah, Prashant; Wylie, Jennifer L; Gopinath, Janakiraman; Balderhaar, Henning; Li, Li; Wuelfing, W Peter; Helmy, Roy
2017-12-01
As science evolves, the need for more efficient and innovative knowledge transfer capabilities becomes evident. Advances in drug discovery and delivery sciences have directly impacted the pharmaceutical industry, though the added complexities have not shortened the development process. These added complexities also make it difficult for scientists to rapidly and effectively transfer knowledge to offset the lengthened drug development timelines. While webcams, camera phones, and iPads have been explored as potential new methods of real-time information sharing, the non-"hands-free" nature and lack of viewer and observer point-of-view render them unsuitable for the R&D laboratory or manufacturing setting. As an alternative solution, the Microsoft HoloLens mixed-reality headset was evaluated as a more efficient, hands-free method of knowledge transfer and information sharing. After completing a traditional method transfer between 3 R&D sites (Rahway, NJ; West Point, PA and Schnachen, Switzerland), a retrospective analysis of efficiency gain was performed through the comparison of a mock method transfer between NJ and PA sites using the HoloLens. The results demonstrated a minimum 10-fold gain in efficiency, weighing in from a savings in time, cost, and the ability to have real-time data analysis and discussion. In addition, other use cases were evaluated involving vendor and contract research/manufacturing organizations. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Norwood, Daniel L; Mullis, James O; Davis, Mark; Pennino, Scott; Egert, Thomas; Gonnella, Nina C
2013-01-01
The structural analysis (i.e., identification) of organic chemical entities leached into drug product formulations has traditionally been accomplished with techniques involving the combination of chromatography with mass spectrometry. These include gas chromatography/mass spectrometry (GC/MS) for volatile and semi-volatile compounds, and various forms of liquid chromatography/mass spectrometry (LC/MS or HPLC/MS) for semi-volatile and relatively non-volatile compounds. GC/MS and LC/MS techniques are complementary for structural analysis of leachables and potentially leachable organic compounds produced via laboratory extraction of pharmaceutical container closure/delivery system components and corresponding materials of construction. Both hyphenated analytical techniques possess the separating capability, compound specific detection attributes, and sensitivity required to effectively analyze complex mixtures of trace level organic compounds. However, hyphenated techniques based on mass spectrometry are limited by the inability to determine complete bond connectivity, the inability to distinguish between many types of structural isomers, and the inability to unambiguously determine aromatic substitution patterns. Nuclear magnetic resonance spectroscopy (NMR) does not have these limitations; hence it can serve as a complement to mass spectrometry. However, NMR technology is inherently insensitive and its ability to interface with chromatography has been historically challenging. This article describes the application of NMR coupled with liquid chromatography and automated solid phase extraction (SPE-LC/NMR) to the structural analysis of extractable organic compounds from a pharmaceutical packaging material of construction. The SPE-LC/NMR technology combined with micro-cryoprobe technology afforded the sensitivity and sample mass required for full structure elucidation. Optimization of the SPE-LC/NMR analytical method was achieved using a series of model compounds
78 FR 16044 - Hazardous Materials Packaging-Composite Cylinder Standards; Public Meeting
2013-03-13
... Toughiry, Engineering and Research Division, Office of Hazardous Materials Safety, Pipeline and Hazardous... the HMR, ISO 11119 Parts-1, -2 and -3, contain design, construction and testing requirements that are.../permits-approvals/special-permits . II. Public Meeting Topics During this public meeting, PHMSA will...
International Nuclear Information System (INIS)
Hastings, S.
1999-01-01
Full text: The crystallisation process is an important unit operation for the separation and purification of many chemical products, particularly in the pharmaceutical industry. Variations in the conditions of crystallisation can lead to the formation of different polymorphic forms which are often meta-stable phases which results in phase conversion at different rates to the stable form. Our group, in collaboration with many industrial sponsors, have developed a number of online techniques which help to optimise the processing conditions of many of these specialty materials. In particular, on-line and in-situ X-ray diffraction (XRD) has been used to monitor the crystallisation of pharmaceutical materials. Several novel in-situ X-ray cells have been developed, in particular; a solution cell, which allows us to control and hence optimise crystallographic conditions such as temperature and pH whilst monitoring the crystal structure of the sample as it crystallises from solution. In conjunction with XRD data information on turbidity (% light transmittance) is taken to analyse solvent-mediated crystallisation. This technique gives information on the temperatures at which the system crystallises and dissolves. From this the meta-stable zone width (MSZW) can be calculated and then directly related to the crystal structure of the particles formed. The current system being studied is the crystallisation of stearic acid, a common pharmaceutical excipient, in various polar and non-polar solvents in order to ascertain the effect that the polarity of the solvent has on the polymorphic form crystallised. By combining such kinetic assessment with measurements of resulting particle structure the potential to optimise the process to produce optimal particle properties is obtainable. Copyright (1999) Australian X-ray Analytical Association Inc
Doctors and pharmaceutical industry.
Beran, Roy G
2009-09-01
The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.
Impacts of international sanctions on Iranian pharmaceutical market.
Cheraghali, Abdol Majid
2013-07-31
Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients.
Alkhaled, Lina; Kahale, Lara; Nass, Hala; Brax, Hneine; Fadlallah, Racha; Badr, Kamal; Akl, Elie A
2014-07-01
Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians. The objective of this study was to systematically review the effects of interventions targeting practising physicians' interactions with pharmaceutical companies. We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies. The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Of 11 189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a 'collaborative approach' between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour. We identified too few studies to allow strong conclusions. Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians' prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical
Diagnostic and therapeutic radio pharmaceutical capsules
International Nuclear Information System (INIS)
Haney, T.A.; Wedeking, P.W.; Morcos, N.A.
1981-01-01
An improved pharmaceutical radioactive capsule consisting of a non-toxic, water soluble material adapted to being ingested and rapidly disintegrating on contact with fluids of the gastro-intestinal tract is described. Each capsule is provided with filler material supporting a pharmaceutically useful radioactive compound absorbable from the gastro-intestinal tract. The capsule is preferably of gelatin, methyl cellulose or polyvinyl alcohol and the filler is a polyethylene glycol. The radioactive compound may be iodine e.g. sodium radioiodide I-131 or 123. The capsule may also contain a reducing agent e.g. sodium thiosulphate, sulphite, or bisulphite. (author)
Martin, Emily
2006-06-01
In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.
[Written pharmaceutical advertising--still unreliable?].
Gladsø, Kristin Haugen; Garberg, Hedda Rosland; Spigset, Olav; Slørdal, Lars
2014-09-02
Marketing by the pharmaceutical industry affects doctors' prescribing habits. All pharmaceutical advertising received by nine doctors in two GP offices over a period of three months was collected. The advertising material was sorted by compound. For each compound, the advert with the highest number of references was selected. The cited references were obtained, and the claims in the adverts were assessed in terms of their consistency with the source data based on the provisions in the Norwegian regulations on pharmaceuticals. The references were also assessed with regard to the incidence of conflicts of interest among authors. The doctors received a total of 270 shipments of advertising for 46 different compounds. Altogether 95% of the 173 references cited in the 46 selected adverts could be obtained. The adverts contained a total of 156 claims. Of these, 56% were assessed as correct when compared to the source data and as having clinical relevance. Altogether 75% of the journal articles reported relevant conflicts of interest for the authors. About half the claims in the adverts were found to be correct and clinically relevant. These results concur with those from a methodologically identical study based on advertising material collected in 2004. The cited literature was of varying quality and often funded by the pharmaceutical companies. The findings indicate that the target group should be sceptical of this type of marketing.
Directory of Open Access Journals (Sweden)
Minzi Omary
2008-12-01
Full Text Available Abstract Background International initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the President's Emergency Plan for AIDS Relief and the President's Malaria Initiative have significantly increased availability and access to medicines in some parts of the developing world. Despite this, however, skills remain limited on quantifying needs for medications and ordering, receiving and storing medications appropriately; recording medications inventories accurately; distributing medications for use appropriately; and advising patients on how to use medications appropriately. The Regional Technical Resource Collaboration for Pharmaceutical Management (RTRC has been established to help address the problem of skills shortage in pharmaceutical management in East Africa. Methods The initiative brings together academic institutions from four East African countries to participate in skills-building activities in pharmaceutical supply management. The initiative targeted the institutions' ability to conduct assessments of pharmaceutical supply management systems and to develop and implement effective skills-building programmes for pharmaceutical supply chain management. Results Over a two-year period, the RTRC succeeded in conducting assessments of pharmaceutical supply management systems and practices in Kenya, Rwanda, Tanzania and Uganda. In 2006, the RTRC participated in a materials-development workshop in Kampala, Uganda, and contributed to the development of comprehensive HIV/AIDS pharmaceutical management training materials; these materials are now widely available in all four countries. In Tanzania and Uganda the RTRC has been involved with the training of health care workers in HIV/AIDS pharmaceutical management. In Kenya, Tanzania and Uganda the RTRC has been conducting operations research to find solutions to their countries' skills-shortage problems. Some of the interventions tested include applying and evaluating the
Knowledge and practice of pharmaceutical care by community ...
African Journals Online (AJOL)
There is a global strategy to improve health through prompt identification and treatment of diseases. The pharmacy profession has remodelled its roles in an attempt to meet these global expectations through pharmaceutical care. The objective of this study was therefore to assess the knowledge and practice of ...
Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude
2017-09-18
Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.
Feenstra, Peter; Brunsteiner, Michael; Khinast, Johannes
2014-10-01
The interaction between drug products and polymeric packaging materials is an important topic in the pharmaceutical industry and often associated with high costs because of the required elaborative interaction studies. Therefore, a theoretical prediction of such interactions would be beneficial. Often, material parameters such as the octanol water partition coefficient are used to predict the partitioning of migrant molecules between a solvent and a polymeric packaging material. Here, we present the investigation of the partitioning of various migrant molecules between polymers and solvents using molecular dynamics simulations for the calculation of interaction energies. Our results show that the use of a model for the interaction between the migrant and the polymer at atomistic detail can yield significantly better results when predicting the polymer solvent partitioning than a model based on the octanol water partition coefficient. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.
Pharmaceutical Cocrystals: New Solid Phase Modification Approaches for the Formulation of APIs
Directory of Open Access Journals (Sweden)
Anna Karagianni
2018-01-01
Full Text Available Cocrystals can be used as an alternative approach based on crystal engineering to enhance specific physicochemical and biopharmaceutical properties of active pharmaceutical ingredients (APIs when the approaches to salt or polymorph formation do not meet the expected targets. In this article, an overview of pharmaceutical cocrystals will be presented, with an emphasis on the intermolecular interactions in cocrystals and the methods for their preparation. Furthermore, cocrystals of direct pharmaceutical interest, along with their in vitro properties and available in vivo data and characterization techniques are discussed, highlighting the potential of cocrystals as an attractive route for drug development.
Pharmaceutical Cocrystals: New Solid Phase Modification Approaches for the Formulation of APIs.
Karagianni, Anna; Malamatari, Maria; Kachrimanis, Kyriakos
2018-01-25
Cocrystals can be used as an alternative approach based on crystal engineering to enhance specific physicochemical and biopharmaceutical properties of active pharmaceutical ingredients (APIs) when the approaches to salt or polymorph formation do not meet the expected targets. In this article, an overview of pharmaceutical cocrystals will be presented, with an emphasis on the intermolecular interactions in cocrystals and the methods for their preparation. Furthermore, cocrystals of direct pharmaceutical interest, along with their in vitro properties and available in vivo data and characterization techniques are discussed, highlighting the potential of cocrystals as an attractive route for drug development.
Pharmaceutical Cocrystals: New Solid Phase Modification Approaches for the Formulation of APIs
Anna Karagianni; Maria Malamatari; Kyriakos Kachrimanis
2018-01-01
Cocrystals can be used as an alternative approach based on crystal engineering to enhance specific physicochemical and biopharmaceutical properties of active pharmaceutical ingredients (APIs) when the approaches to salt or polymorph formation do not meet the expected targets. In this article, an overview of pharmaceutical cocrystals will be presented, with an emphasis on the intermolecular interactions in cocrystals and the methods for their preparation. Furthermore, cocrystals of direct phar...
ETHICAL ASPECTS OF THE COOPERATION BETWEEN PHYSICIAN AND PHARMACEUTICAL INDUSTRY
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Jože Drinovec
2001-09-01
Full Text Available Background. It is not possible to isolated ethical aspects and norms in the work of physician from the professional and scientific ones. The physician will not act contrary to ethical principles if he will work for the interests of the patient and in accordance with scientific knowledge.Present situation and possible solutions. Every physician, especially if working in university institution is co-operating with pharmaceutical industry, at least he is makes the prescriptions and chooses one drug of the possible ones. There are also other aspects of co-operation: clinical trials, writing expertise and lectures at scientific meetings, sponsored by pharmaceutical industry. There are guidelines and codex in Western countries for more than ten years, which regulate the relation between physician and pharmaceutical industry. The most important ones are those from World Health Organisation, European Federation of Pharmaceutical Industries’ Associations’, and International Federation of Pharmaceutical Manufacturers Associations’. Scientific independence of lecturers and writers is tried to be achieved by disclosure of relevant financial relation with pharmaceutical corporation in advance.Conclusions. Physician working with pharmaceutical industry has o follow the guidelines of international professional associations. He/she has to be independent relaying only upon scientific and professional principles seeing primary the benefit of the patient.
Kasprzyk-Hordern, Barbara; Dinsdale, Richard M; Guwy, Alan J
2009-06-01
This manuscript is part two of a two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. In this paper pharmaceuticals were investigated as potential chemical indicators of water contamination with sewage. The monitoring program carried out in Wales revealed that some pharmaceuticals are particularly persistent and/or ubiquitous in contaminated river water and therefore might be considered as potential conservative or labile wastewater indicators. In particular, these include some anti-inflammatory/analgesics, antiepileptics, beta-blockers, some H2-receptor antagonists and antibacterial drugs.
Adsorptive removal of selected pharmaceuticals by mesoporous silica SBA-15
International Nuclear Information System (INIS)
Bui, Tung Xuan; Choi, Heechul
2009-01-01
The removal of five selected pharmaceuticals, viz., carbamazepine, clofibric acid, diclofenac, ibuprofen, and ketoprofen was examined by batch sorption experiments onto a synthesized mesoporous silica SBA-15. SBA-15 was synthesized and characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), N 2 adsorption-desorption measurement, and point of zero charge (PZC) measurement. Pharmaceutical adsorption kinetics was rapid and occurred on a scale of minutes, following a pseudo-second-order rate expression. Adsorption isotherms were best fitted by the Freundlich isotherm model. High removal rates of individual pharmaceuticals were achieved in acidic media (pH 3-5) and reached 85.2% for carbamazepine, 88.3% for diclofenac, 93.0% for ibuprofen, 94.3% for ketoprofen, and 49.0% for clofibric acid at pH 3 but decreased with increase in pH. SBA-15 also showed high efficiency for removal of a mixture of 5 pharmaceuticals. Except for clofibric acid (35.6%), the removal of pharmaceuticals in the mixture ranged from 75.2 to 89.3%. Based on adsorption and desorption results, the mechanism of the selected pharmaceuticals was found to be a hydrophilic interaction, providing valuable information for further studies to design materials for the purpose. The results of this study suggest that mesoporous-silica-based materials are promising adsorbents for removing pharmaceuticals from not only surface water but also wastewater of pharmaceutical industrial manufactures.
Adsorptive removal of selected pharmaceuticals by mesoporous silica SBA-15
Energy Technology Data Exchange (ETDEWEB)
Bui, Tung Xuan, E-mail: bxtung@gist.ac.kr [Department of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of); Choi, Heechul, E-mail: hcchoi@gist.ac.kr [Department of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of)
2009-09-15
The removal of five selected pharmaceuticals, viz., carbamazepine, clofibric acid, diclofenac, ibuprofen, and ketoprofen was examined by batch sorption experiments onto a synthesized mesoporous silica SBA-15. SBA-15 was synthesized and characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), N{sub 2} adsorption-desorption measurement, and point of zero charge (PZC) measurement. Pharmaceutical adsorption kinetics was rapid and occurred on a scale of minutes, following a pseudo-second-order rate expression. Adsorption isotherms were best fitted by the Freundlich isotherm model. High removal rates of individual pharmaceuticals were achieved in acidic media (pH 3-5) and reached 85.2% for carbamazepine, 88.3% for diclofenac, 93.0% for ibuprofen, 94.3% for ketoprofen, and 49.0% for clofibric acid at pH 3 but decreased with increase in pH. SBA-15 also showed high efficiency for removal of a mixture of 5 pharmaceuticals. Except for clofibric acid (35.6%), the removal of pharmaceuticals in the mixture ranged from 75.2 to 89.3%. Based on adsorption and desorption results, the mechanism of the selected pharmaceuticals was found to be a hydrophilic interaction, providing valuable information for further studies to design materials for the purpose. The results of this study suggest that mesoporous-silica-based materials are promising adsorbents for removing pharmaceuticals from not only surface water but also wastewater of pharmaceutical industrial manufactures.
Directory of Open Access Journals (Sweden)
N. Slushaenko
2015-04-01
Full Text Available This article investigated the role of pricing for strategic activities of pharmaceutical companies. It has been modified Bass diffusion model for new products, and it has been conducted empirical testing of the model on the sample of the products of the Ukrainian pharmaceutical market. Among the analyzed pricing models for new product allocated to one that meets the needs of the pharmaceutical industry and is based on available statistics. Formed a clear selection algorithm pricing policy of the company to the new product.
Report of the consultants' meeting on traceability of IAEA-AQCS reference materials to SI-units
International Nuclear Information System (INIS)
2002-01-01
The purpose of the meeting was to discuss the present Agency's Analytical Quality Control Services (AQCS) procedure for the characterization of reference materials and to identify necessary improvements or changes needed to fulfill the requirements on traceability and uncertainty related to the property value of IAEA reference materials. This publication contains a summary of the discussions held at the meeting as well as specific recommendations made by the consultants. It also contains draft reports of two previous meetings and individual papers presented by the consultants at the meeting. These reports and papers have been provided with abstracts and indexed separately
The coefficient of rolling resistance (CoRR) of some pharmaceutical tablets.
Ketterhagen, William R; Bharadwaj, Rahul; Hancock, Bruno C
2010-06-15
Experiments have been conducted to measure the coefficient of rolling resistance (CoRR) of some pharmaceutical tablets and several common materials, such as glass beads and steel ball bearings. CoRR values are required as inputs for discrete element method (DEM) models which can be used to model particulate flows and solid dosage form manufacturing processes. Until now there have been no CoRR data reported for pharmaceutical materials, and thus these new data will help to facilitate more accurate modeling of pharmaceutical systems. Copyright 2010 Elsevier B.V. All rights reserved.
Care ideologies reflected in 4 conceptions of pharmaceutical care.
Björkman, Ingeborg K; Bernsten, Cecilia B; Sanner, Margareta A
2008-12-01
Different ways to practice pharmaceutical care have been developed. One expression of this fact is the existence of many different classification systems to document drug-related problems (DRPs). Evidence suggests that classification systems have different characteristics and that these characteristics reflect different conceptions of pharmaceutical care. To increase the understanding of conceptions of pharmaceutical care, underlying values and beliefs (ideologies) can be explored. To explore various conceptions of pharmaceutical care to identify the care ideologies on which these conceptions are based. Representatives of 4 selected conceptions of pharmaceutical care were interviewed in face-to-face meetings. During the interviews, 4 basic questions were asked. Three were focused on pharmaceutical care and 1 on DRPs. Interview transcripts were analyzed by an inductive method inspired by grounded theory. The conceptions studied were Strand, Granada-II, PCNE v5.0, and Apoteket. In Strand, patients are given a more active role in the pharmaceutical care process, as compared to Granada-II, PCNE v5.0, and Apoteket. Pharmacists in all the conceptions of pharmaceutical care assume they have special knowledge that patients benefit from. However, they use their knowledge in different ways in the various pharmaceutical care conceptions. In Strand, individual goals of drug therapy are established together with the patient, whereas in Granada-II, PCNE, and Apoteket goals are not explicitly discussed. The identified differences correspond to different care ideologies. The pharmaceutical care conceptions are based on different care ideologies. The ideology is expressed in how therapy goals are set and patient needs defined. Strand is based on a patient-centered ideology; patient therapy goals and needs are defined by the patient together with the practitioners. Granada-II, PCNE, and Apoteket are based on an evidence-based medicine approach; patient therapy goals and needs are
The future of the pharmaceutical, biological and medical device industry
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Burgess LJ
2011-09-01
Full Text Available Lesley J Burgess, Marli TerblancheTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South AfricaAbstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.Keywords: pharmaceutical industry, personalized medicine, trends, generics, biotechnology
2013-02-05
... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS) Meeting of the Joint ACRS Subcommittees on Thermal Hydraulic Phenomena and Materials, Metallurgy and Reactor Fuels; Notice of Meeting The Joint ACRS Subcommittees on Thermal Hydraulic Phenomena and Materials, Metallurgy and...
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Marta Makowska
Full Text Available This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health.It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland.The majority of respondents (96.8% said that they had talked with pharmaceutical sales representatives (PSRs in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3% said they trusted the information provided by PSRs. Over one third of respondents (36.4% claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law.The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical
Makowska, Marta
2017-01-01
This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical guidelines
2017-01-01
Objective This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. Methods It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians’ website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. Results The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. Conclusions The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency
Directory of Open Access Journals (Sweden)
Kyu-Hwan SIHN
2015-12-01
Full Text Available After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The
Sihn, Kyu-Hwan
2015-12-01
After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for
International Nuclear Information System (INIS)
Janev, R.K.; Longhurst, G.
1998-12-01
The proceedings and conclusions of the 1st IAEA Research Co-ordination Meeting on 'Plasma-Material Interaction Data for Mixed Plasma Facing Materials in Fusion Reactors', held on December 19 and 20, 1998 at the IAEA Headquarters in Vienna, are briefly described. This report includes a summary of the presentations made by meeting participants, a review of the data availability and data needs in the areas from the scope of the Co-ordinated Research Project (CRP) on the subject of the meeting, and recommendations regarding the future work within this CRP. (author)
Code of ethics for the national pharmaceutical system: Codifying and compilation.
Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin
2013-05-01
Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended.
Concept of the Ural pharmaceutical cluster formation
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Aleksandr Petrovich Petrov
2011-06-01
Full Text Available This paper substantiates the necessity of cluster organization of the pharmaceutical industry in the region. The estimation of the state and prospects of development of such structures in the domestic economy is given. Sverdlovsk region was chosen as the object of study on the possibility of forming a pharmaceutical cluster. Objective prerequisites for the organization of a cluster of pharmaceutical production in Sverdlovsk region are considered, among these were distinguished: capacious and fast-growing market for pharmaceutical products, availability of potential development of the pharmaceutical industry in the territory and the key success factors for enterprises - potential participants of the cluster. Indicated key success factors are: presence of a creative team and close interaction between business and government, high level of cooperation among the enterprises of the cluster and commercialization of products, implementation of research and development expenditures etc. Thus, it was substantiated that in there all references and resources for the formation of a pharmaceutical cluster. The concept of formation and development of the Ural pharmaceutical cluster was elaborated. Inside the concept, the goals, objectives, processing, product and organizational priorities for cluster formation are identified. Architecture of this structure with a justification of its members and certain forms of interaction between them is proposed. The stages of formation and development of the Ural pharmaceutical cluster on the basis of a ten-year settlement period for the full range of activities for this project are substantiated. At each stage, a set of key objectives and results of the cluster was defined. The choice of phases was carried out on the basis of investment programs of cluster's enterprises strategic position on the mastering of markets and infrastructure development. An assessment of socio-economic efficiency of the Ural pharmaceutical
Konduri, Niranjan; Rauscher, Megan; Wang, Shiou-Chu Judy; Malpica-Llanos, Tanya
2017-01-01
Medicines use related challenges such as inadequate adherence, high levels of antimicrobial resistance and preventable adverse drug reactions have underscored the need to incorporate pharmaceutical services to help achieve desired treatment outcomes, and protect patients from inappropriate use of medicines. This situation is further constrained by insufficient numbers of pharmaceutical personnel and inappropriate skill mix. Studies have addressed individual capacity building approaches of logistics, supply chain or disease specific interventions but few have documented those involving such pharmacy assistants/professionals, or health workers/professionals charged with improving access and provision of pharmaceutical services. We examined how different training modalities have been employed and adapted to meet country-specific context and needs by a global pharmaceutical systems strengthening program in collaboration with a country's Ministry of Health and local stakeholders. Structured, content analysis of training approaches from twelve selected countries and a survey among conveniently selected trainees in Bangladesh and Ethiopia. Case-based learning, practice and feedback, and repetitive interventions such as post-training action plan, supportive supervision and mentoring approaches are effective, evidence-based training techniques. In Ethiopia and Bangladesh, over 94% of respondents indicated that they have improved or developed skills or competencies as a result of the program's training activities. Supportive supervision structures and mentorship have been institutionalized with appropriate management structures. National authorities have been sensitized to secure funding from domestic resources or from the global fund grants for post-training follow-up initiatives. The Pharmaceutical Leadership Development Program is an effective, case-based training modality that motivates staff to develop quality-improvement interventions and solve specific challenges
Welch, K.; Mousavi, S.; Lundberg, B.; Strømme, M.
2005-09-01
A newly developed method for determining the frequency-dependent complex Young's modulus was employed to analyze the mechanical response of compacted microcrystalline cellulose, sorbitol, ethyl cellulose and starch for frequencies up to 20 kHz. A Debye-like relaxation was observed in all the studied pharmaceutical excipient materials and a comparison with corresponding dielectric spectroscopy data was made. The location in frequency of the relaxation peak was shown to correlate to the measured tensile strength of the tablets, and the relaxation was interpreted as the vibrational response of the interparticle hydrogen and van der Waals bindings in the tablets. Further, the measured relaxation strength, holding information about the energy loss involved in the relaxation processes, showed that the weakest material in terms of tensile strength, starch, is the material among the four tested ones that is able to absorb the most energy within its structure when exposed to external perturbations inducing vibrations in the studied frequency range. The results indicate that mechanical relaxation analysis performed over relatively broad frequency ranges should be useful for predicting material properties of importance for the functionality of a material in applications such as, e.g., drug delivery, drug storage and handling, and also for clarifying the origin of hitherto unexplained molecular processes.
The pharmaceutical death-ride of dihydroartemisinin.
Jansen, Frans Herwig
2010-07-22
In the 2010 second edition of WHO's guidelines for the treatment of malaria, the relatively new fixed dose combination dihydroartemisinin-piperaquine is included as one of the recommended artemisinin combination therapies. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements. At a time when many efforts aim to ban counterfeit and substandard drugs from the malaria market, the obvious question rises how WHO and public-private partnerships, such as Medicine for Malaria venture (MMV), can support the production and marketing of anti-malarial drugs that do not even meet the International Pharmacopoeia requirements?
The pharmaceutical death-ride of dihydroartemisinin
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Jansen Frans
2010-07-01
Full Text Available Abstract In the 2010 second edition of WHO's guidelines for the treatment of malaria, the relatively new fixed dose combination dihydroartemisinin-piperaquine is included as one of the recommended artemisinin combination therapies. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements. At a time when many efforts aim to ban counterfeit and substandard drugs from the malaria market, the obvious question rises how WHO and public-private partnerships, such as Medicine for Malaria venture (MMV, can support the production and marketing of anti-malarial drugs that do not even meet the International Pharmacopoeia requirements?
Stults, Cheryl L M; Ansell, Jennifer M; Shaw, Arthur J; Nagao, Lee M
2015-02-01
Polymeric materials are often used in pharmaceutical packaging, delivery systems, and manufacturing components. There is continued concern that chemical entities from polymeric components may leach into various dosage forms, particularly those that are comprised of liquids such as parenterals, injectables, ophthalmics, and inhalation products. In some cases, polymeric components are subjected to routine extractables testing as a control measure. To reduce the risk of discovering leachables during stability studies late in the development process, or components that may fail extractables release criteria, it is proposed that extractables testing on polymer resins may be useful as a screening tool. Two studies have been performed to evaluate whether the extractables profile generated from a polymer resin is representative of the extractables profile of components made from that same resin. The ELSIE Consortium pilot program examined polyvinyl chloride and polyethylene, and another study evaluated polypropylene and a copolymer of polycarbonate and acrylonitrile butadiene styrene. The test materials were comprised of polymer resin and processed resin or molded components. Volatile, semi-volatile, and nonvolatile chemical profiles were evaluated after headspace sampling and extraction with solvents of varying polarity and pH. The findings from these studies indicate that there may or may not be differences between extractables profiles obtained from resins and processed forms of the resin depending on the type of material, the compounds of interest, and extraction conditions used. Extractables testing of polymer resins is useful for material screening and in certain situations may replace routine component testing.
Stegemann, S; Baeyens, J-P; Becker, R; Maio, M; Bresciani, M; Shreeves, T; Ecker, F; Gogol, M
2014-06-01
Drugs represent the most common intervention strategy for managing acute and chronic medical conditions. In light of demographic change and the increasing age of patients, the classic model of drug research and development by the pharmaceutical industry and drug prescription by physicians is reaching its limits. Different stakeholders, e.g. industry, regulatory authorities, health insurance systems, physicians etc., have at least partially differing interests regarding the process of healthcare provision. The primary responsibility for the correct handling of medication and adherence to treatment schedules lies with the recipient of a drug-based therapy, i.e. the patient. It is thus necessary to interactively involve elderly patients, as well as the other stakeholders, in the development of medication and medication application devices, and in clinical trials. This approach will provide the basis for developing a strategy that better meets patients' needs, thus resulting in improved adherence to treatment schedules and better therapeutic outcomes.
Characterization and testing of materials for nuclear reactors. Proceedings of a technical meeting
International Nuclear Information System (INIS)
2007-03-01
Nuclear techniques in general and neutrons based methods in particular have played and will continue to play an important role in research in materials science and technology. Today the world is looking at nuclear fission and nuclear fusion as the main sources of energy supply for the future. Research reactors have played a key role in the development of nuclear technology. A materials development programme will thus play a major role in the design and development of new nuclear power plants, for the extension of the life of operating reactors as well as for fusion reactors. Against this background, the IAEA had organized a Technical Meeting on Development, Characterization and Testing of Materials - With Special Reference to the Energy Sector under the activity on specific applications of research reactors. The meeting was held in Vienna, May 29- June 2, 2006. There was also participation by experts in techniques, complementary to neutrons. The participants for the technical meeting were experts in the utilization of nuclear techniques namely the high flux and medium flux research reactors, fusion research and positron annihilation. They presented the design, development and utilization of the facilities at their respective centres for materials characterization with main focus on materials for nuclear energy, both fission and fusion. In core irradiation of materials, development of instrument for residual stress measurement in large and / or irradiated specimen, neutron radiography for inspection of irradiated fuel, work on oxide dispersion strengthened (ODS) steels and SiC composites, relevant to future power systems were cited as application of nuclear techniques in fission reactors. The use of neutron scattering for helium bubbles in steel, application of positron annihilation to study helium bubbles in Cu, Ti-stabilized stainless steel and voidswelling studies etc. show that these techniques have an important role in the development of materials for energy
Directory of Open Access Journals (Sweden)
T Ashino
2008-11-01
Full Text Available On March 4-5, 2008, the CODATA Task Group for Exchangeable Material Data Representation to Support Research and Education held a two day seminar cum meeting at the National Physical Laboratory (NPL, New Delhi, India, with NPL materials researchers and task group members representing material activities and databases from seven countries: European Union (The Czech Republic, France, and the Netherlands, India, Korea, Japan, and the United States. The NPL seminar included presentations about the researchers' work. The Task Group meeting included presentations about current data related activities of the members. Joint discussions between NPL researchers and CODATA task group members began an exchange of viewpoints among materials data producers, users, and databases developers. The seminar cum meeting included plans to continue and expand Task Group activities at the 2008 CODATA 21st Meeting in Kyiv, Ukraine.
International Nuclear Information System (INIS)
1996-12-01
At the invitation of the Government of the Russian Federation, following a proposal of the International Working Group on Water Reactor Fuel Performance and Technology, the IAEA convened a Technical Committee Meeting on Behaviour of LWR Core Materials Under Accident Conditions from 9 to 13 October 1995 in Dimitrovgrad to analyze and evaluate the behaviour of LWR core materials under accident conditions with special emphasis on severe accidents. In-vessel severe accidents phenomena were considered in detail, but specialized thermal hydraulic aspects as well as ex-vessel phenomena were outside the scope of the meeting. Forty participants representing eight countries attended the meeting. Twenty-three papers were presented and discussed during five sessions. Refs, figs, tabs
Proceedings, annual meeting - Institute of Nuclear Materials Management, 21st, 1980
International Nuclear Information System (INIS)
Anon.
1980-01-01
This meeting proceedings contains 84 papers by various authors. Some of the topics discussed are: safeguards today and tomorrow; physical protection-requirements and rules; safeguards measurement technology; nonproliferation and international safeguards; analysis and interpretation of materials accounting data; physical protection; safeguards evaluation methodologies; public information; emergency response for accounting and physical security systems; materials control and accountability systems; and safeguards measurements technology. 78 papers are separately indexed
International Nuclear Information System (INIS)
Kasprzyk-Hordern, Barbara; Dinsdale, Richard M.; Guwy, Alan J.
2009-01-01
This manuscript is part two of a two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. In this paper pharmaceuticals were investigated as potential chemical indicators of water contamination with sewage. The monitoring program carried out in Wales revealed that some pharmaceuticals are particularly persistent and/or ubiquitous in contaminated river water and therefore might be considered as potential conservative or labile wastewater indicators. In particular, these include some anti-inflammatory/analgesics, antiepileptics, beta-blockers, some H2-receptor antagonists and antibacterial drugs. - Wastewater as an indicative source of information can be used in forensic applications.
Energy Technology Data Exchange (ETDEWEB)
Kasprzyk-Hordern, Barbara, E-mail: B.Kasprzyk-Hordern@hud.ac.u [University of Huddersfield, Department of Chemical and Biological Sciences, Queensgate, Huddersfield HD1 3DH (United Kingdom); University of Glamorgan, Sustainable Environment Research Centre, Faculty of Health, Sport and Science, Pontypridd CF37 1DL (United Kingdom); Dinsdale, Richard M.; Guwy, Alan J. [University of Glamorgan, Sustainable Environment Research Centre, Faculty of Health, Sport and Science, Pontypridd CF37 1DL (United Kingdom)
2009-06-15
This manuscript is part two of a two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. In this paper pharmaceuticals were investigated as potential chemical indicators of water contamination with sewage. The monitoring program carried out in Wales revealed that some pharmaceuticals are particularly persistent and/or ubiquitous in contaminated river water and therefore might be considered as potential conservative or labile wastewater indicators. In particular, these include some anti-inflammatory/analgesics, antiepileptics, beta-blockers, some H2-receptor antagonists and antibacterial drugs. - Wastewater as an indicative source of information can be used in forensic applications.
PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...
Modern sanitary practices result in large volumes of human waste, as well as domestic and industrial sewage, being collected and treated at common collection points, wastewater treatment plants (WWTP). In recognition of the growing use of sewage sludges as a fertilizers and as soilamendments, and the scarcity of current data regarding the chemical constituents in sewage sludges, the United States National Research Council (NRC) in 2002 produced a report on sewage sludges. Among the NRC's recommendations was the need for investigating the occurrence of pharmaceuticals and personal care products (PPCPs) in sewage sludges. PPCPsare a diverse array of non-regulated contaminants that had not been studied in previous sewage sludges surveys but which are likely to be present. The focus of this paper will be to review the current analytical methodologies available for investigating whether pharmaceuticals are present in WWTP-produced sewage sludges, to summarize current regulatory practices regarding sewage sludges, and to report on the presence of pharmaceuticals in sewage sludges. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subta
Pharmaceutical care: the PCNE definition 2013.
Allemann, Samuel S; van Mil, J W Foppe; Botermann, Lea; Berger, Karin; Griese, Nina; Hersberger, Kurt E
2014-06-01
Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the
Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.
de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M
2018-01-01
Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical
International Nuclear Information System (INIS)
Katusin-Razem, B.; Novak, B.; Razem, D.
2001-01-01
Microbiological contamination typical of botanical raw materials used in the manufacture of pharmaceuticals decreases with the increasing level of processing, on going from flowers and leaves (10 4 -10 8 CFU/g), to fruits and seeds (10 2 -10 6 CFU/g), to liquid extracts (10 4 -10 6 CFU/g), and to dry extracts (10 2 -10 5 CFU/g). At the same time the resistivity of microflora to irradiation, expressed as a dose required for the first 90% reduction, increases along the same assortment as 2, 4, 5 and 5 kGy, respectively. This results in doses between 4 and 30 kGy required to treat typical contamination, or between 10 and 40 kGy for severe cases. The contamination of final products, phyto-therapeutic ointments (10 4 -10 7 CFU/g), is relatively sensitive to irradiation (D first90%red =1 kGy) and usually does not require doses higher than 8 kGy
INAA of polyacrylic hydrogels of pharmaceutical grade
International Nuclear Information System (INIS)
Ponta, C.; Salagean, M.; Pantelica, A.; Georgescu, I.I.
1998-01-01
Polyacrylic acid (PA) and its salts are promising biomaterials used in the pharmaceutical industry. They could be used as pharmaceutical additives, as a burn dressing and also in the slow released implants or trans-derma patch formulations. Polyacrylic acid of pharmaceutical grade can be obtained by gamma irradiation polymerization. The influence of the raw materials and of the technological procedure on the final product purity has been investigated by Instrumental Neutron Activation Analysis (INAA) method. The following materials have been analyzed by INAA: 1) acrylic acid of technical grade; 2) acrylic acid purified by double crystallisation; 3) NaOH of analytical grade; 4) CaCl-2·6H 2 O of pharmaceutical grade; 5) CaCl 2 ·2H 2 O of analytical grade; 6) granulated PANa; 7) ungranulated PANa; 8) ungranulated PANaCa; 9) PANaCa granulated by milling in IFIN-HH using the mill nr. 1; 10) PANaCa granulated by milling in Institute of Chemical and Pharmaceutical Research (ICPR); 11) PANaCa granulated by milling in IFIN-HH using the mill nr. 2. The first five samples, marked from 1 to 5, are raw materials and the other six samples, marked from 6 to 11, are the final polyacrylic structures processed by various technological procedures. The samples together with the appropriate reference materials have been irradiated at WWR-S reactor in a neutron flux of 2.5·10 12 cm -2 s -1 and the induced radioactivity was registered by a HPGe detector (EG/G ORTEC) of 30% efficiency and 2.1 keV resolution. The concentrations of As, Br, Ce, Co, Cr, Fe, La, Sb, Sc, Zn have been determined. For the final polyacrylic structures, except for granulated PANa (sample 6), only the elements Co, Cr, Fe, Sc, Zn were found at the following concentration levels: tens of ppm (Co), ppm (Zn), hundreds of ppb (Cr), tens of ppb (Co), ppb (Co, Sc), 10 -1 ppb (Sc). In the granulated PANa, in comparison with the other analyzed final products, similar concentration values were found for Fe, Sc and Zn
Neutron reflectometry: A probe for materials surfaces. Proceedings of a technical meeting
International Nuclear Information System (INIS)
2006-01-01
Research reactors play an important role in delivering the benefits of nuclear science and technology. The IAEA, through its project on the effective utilization of research reactors, has been providing technical support to Member States and promotes activities related to specific applications. Neutron beam research is one of the main components in materials science studies. Neutron reflectometry is extremely useful for characterizing thin films and layered structures, polymers, oxide coatings on metals and biological membranes. The neutron has been a major probe for investigating magnetic materials. Development of magnetic multilayers is important for diverse applications in sensors, memory devices, etc. The special nature of the interaction of the neutron with matter makes it an important tool to locate low z elements in the presence of high z elements, which is useful in biology and polymer science. The role of neutron reflectometry in research and development in materials science and technology was discussed in a consultants meeting held in 2003. Following this, a technical meeting was organized from 16 to 20 August 2004 in Vienna to discuss the current status of neutron reflectometry, including the instrumentation, data acquisition, data analysis and applications. Experts in the field of neutron reflectometry presented their contributions, after which there was a brainstorming session on various aspects of the technique and its applications. This publication is the outcome of deliberations during the meeting and the presentations by the participants. This publication will be of use to scientists planning to develop a neutron reflectometer at research reactors. It will also help disseminate knowledge and information to material scientists, biologists and chemists working towards characterizing and developing new materials
Directory of Open Access Journals (Sweden)
Mostafa Essam Eissa
2016-09-01
Full Text Available Bacterial contamination control in pharmaceutical products is a critical aspect in the field of drug manufacturing industry due to the encountered risk to the patients' health and possibly their life. The application of commercial bacterial identification system is crucial to identify the type of contamination and its source to anticipate the impact of bioburden on the products and setting corrective and preventive actions. During the period of one year, random samples from raw materials and final products were tested according to United States Pharmacopeia, and those that showed suspect results for specified microorganisms and/or out-of-specification limits or showed out-of-trend results were subjected to further identification by using miniaturized biochemical identification system after performing Gram stain. From the total bacterial isolates of the investigated products, more than 60% were primarily belonging to Micrococcaceae 16.98% (empty hard gelatin capsules, Enterobacteriaceae 18.86% (vaginal cream applicator, plastic caps for bottles, Sorbitol solution, finished hard gelatin capsule product, topical cream and oral suspension and Bacillaceae 24.53% (Talc powder, liquid oral preparation and finished hard gelatin capsule product. Gram Positive and Negative samples were 56.60% and 41.51% respectively from the total investigated sample products and materials. Finished pharmaceutical products constituted 53.33% and 68.18% from Gram-positive and Gram-negative microorganisms respectively. An approach to quantitative risk assessment for pharmaceutical products was conducted on selected medicinal items and showed that Enterobacteriaceae followed by Burkholderiaceae contributed by more than 80% to the major hazard that could be delivered to patients through drugs. The applied risk can be used as a milestone for setting goals by pharmaceutical companies to improve the safety of medicinal products microbiologically and to identify the major sources
IAEA consultants' meeting on thermal response of plasma facing materials and components
International Nuclear Information System (INIS)
Janev, R.K.
1990-07-01
The present Summary Report contains brief proceedings and the main conclusions and recommendations of the IAEA Consultants' Meeting on ''Thermal Response of Plasma Facing Materials and Components'', which was organized by the IAEA Atomic and Molecular Data Unit and held on June 11-13, 1990, in Vienna, Austria. The Report also includes a categorization and assessment of currently studied plasma facing materials, a classification scheme of material properties data, required in fusion reactor design, and a survey of the urgently needed material properties data. (author)
International Nuclear Information System (INIS)
Clark, R.E.H.
2003-10-01
The proceedings and conclusions of the Technical Meeting on 'Atomic and Plasma- Material Interaction Data for Fusion Science Technology' held in Juelich, Germany on October 28-31 are summarized. During the course of the meetings working groups were formed to review the status of specific areas of atomic, molecular and material physics of relevance to fusion and to make recommendations on data needs in fusion from these areas. The reports of those working groups are summarized and the complete reports included as appendices. This meeting brought together over fifty leading scientists in fusion related data. Results of research in a number of topics were presented and very useful discussions were held. The meeting was extremely successful. (author)
CATEGORY MANAGEMENT IN THE MANAGEMENT OF MINIMUM ASSORTMENT OF THE PHARMACEUTICAL ORGANIZATION
Directory of Open Access Journals (Sweden)
I. F. Samoshchenkova
2017-01-01
Full Text Available The main principle of the category management is the management of product category as a separate business unit. Category management directs the activities of the pharmaceutical organization to meet the consumer requirements and to provide customers with maximum benefits, which are expressed in the improved assortment,the attractive prices, the reduction of cases of lack of necessary goods, the simplifiedpurchase process. In article the structure of the category management and its role inthe minimum pharmaceutical assortment, a complex of the theoretical and practical issues affecting interrelation of the list of vital and essential medicines and the minimum range of medicines are considered. A number of the new elements supplementing the concept of category management is offered, and the corresponding generalizations are made. The objective of the research is to study the influence of category management on the structure in management of the minimum assortment of medicines of the pharmaceutical organization. Materials and methods. In the course of the solution of the set tasks, the methods of marketing and economic-mathematical analysis were used. Results and discussion. In the analysis of the assortment list of medicines for medical application, which is obligatory for the pharmaceutical enterprises of all forms of ownership, it was revealed that this assortment list is based on the List of Vital Essential and Necessary (VEN Drugs. The results of the analysis of the obligatory assortment list from the position of internal category management showed that 77.45% are medicines of the list of VEN Drugs; 46.08% are medicines of non-prescription dispensing. Proceeding from this it follows that the worthy, profitable price policy can be conducted only with 22.55% of the list; to develop standards of merchandising with 46.05%. The category management gives an opportunity to the pharmaceutical organization to specify its competitive strategy and to
International Nuclear Information System (INIS)
1994-01-01
The Technical Committee Meeting on Material-Coolant Interactions and Material Movement and Relocation in Liquid Metal Fast Reactors was sponsored by the International Working Group on Fast Reactors (IWGFR), International Atomic Energy Agency (IAEA) and hosted by PNC, on behalf of the Japanese government. A broad range of technical subjects was discussed in the TCM, covering entire aspects of material motion and interactions relevant to the safety of LMFRs. Recent achievement and current status in research and development in this area were presented including European out-of-pile test of molten material movement and relocation; molten material-sodium interaction; molten fuel-coolant interaction; core disruptive accidents; sodium boiling; post accident material relocation, heat removal and relevant experiments already performed or planned
Energy Technology Data Exchange (ETDEWEB)
NONE
1994-07-01
The Technical Committee Meeting on Material-Coolant Interactions and Material Movement and Relocation in Liquid Metal Fast Reactors was sponsored by the International Working Group on Fast Reactors (IWGFR), International Atomic Energy Agency (IAEA) and hosted by PNC, on behalf of the Japanese government. A broad range of technical subjects was discussed in the TCM, covering entire aspects of material motion and interactions relevant to the safety of LMFRs. Recent achievement and current status in research and development in this area were presented including European out-of-pile test of molten material movement and relocation; molten material-sodium interaction; molten fuel-coolant interaction; core disruptive accidents; sodium boiling; post accident material relocation, heat removal and relevant experiments already performed or planned.
The accumulation and management of pharmaceutical waste in the community pharmacy
Latožienė, Rima
2017-01-01
The Accumulation and Management of Pharmaceutical Waste in the Community Pharmacy Authors: students Diana Patašienė and Rima Latožienė, pharmacy master program at Vilnius University Faculty of Medicine, Department of Pathology, Forensic Medicine and Pharmacology. Work Leader: Dr. Kristina Garuolienė. The aim of the study: to determine pharmaceutical waste formation causes and to assess pharmaceutical waste management problems at community pharmacies. Materials and methods: The study was condu...
Editorial Nano structures for Medicine and Pharmaceuticals
International Nuclear Information System (INIS)
Xing-Jie, L.; Kumar, A.; Donglu, S.; Daxiang, C.
2012-01-01
The rapid developments in nano structured materials and nano technology will have profound impact in many areas of biomedical applications including delivery of drugs and biomolecules, tissue engineering, detection of bio markers, cancer diagnosis, cancer therapy, and imaging. This field is expanding quickly, and a lot of work is ongoing in the design, characterization, synthesis, and application of materials, for controlling shape and size at nanometer scale to develop highly advanced materials for biomedical application and even to design better pharmaceutical products. In recent years, novel nano structure with multi functionalities has been focused on the use of nano structures toward solving problems of biology and medicine. The main scope of this special issue is to demonstrate the latest achievement of nano technology and its application in nano medicine particularly in new approaches for drug delivery such as targeted drug delivery system, nano structure for drug storage, nano materials for tissue engineering, medical diagnosis and treatment, and generation of new kinds of materials from biological sources. Therefore, many critical issues in nano structured materials, particularly their applications in biomedicine, must be addressed before clinical applications. This special issue devotes several review and research articles encompassing various aspects of nano materials for medicine and pharmaceuticals.
Ethical pharmaceutical promotion and communications worldwide: codes and regulations
2014-01-01
The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064
Ethical pharmaceutical promotion and communications worldwide: codes and regulations.
Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul
2014-03-29
The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.
Radiosterilization of medical products, pharmaceuticals and bioproducts
International Nuclear Information System (INIS)
1967-01-01
A Panel on the Radiosterilization of Medical Products, Pharmaceuticals and Bioproducts was convened by the International Atomic Energy Agency on 17-19 January 1966 at its headquarters in Vienna. The purpose of the meeting was to survey the activities of the Member States in this field with a view to preparing the way for an international code of practice for the radiosterilization of medical products, in conformity with existing legal international rules. Refs, figs and tabs
Singh, Deepika; Suthar, Surindra
2012-05-01
Efforts were made to decompose herbal pharmaceutical industrial waste (HPIW) spiked with cow dung (CD) using Eisenia fetida. A total of five vermibeds: T(1) - HPIW (0%+CD 100%, control), T(2) - HPIW (25%), T(3) - HPIW (50%), T(4) - HPIW (75%) and T(5) - HPIW (100%) were used for vermicomposting. The changes in biology and chemistry of vermibeds were measured after ten days interval. E. fetida showed high growth and cocoon production rate in all vermibeds. The vermicomposted material contained great population of fungi 6.0-40.6 (CFU × 10(5)g(-1)), bacteria 220-1276.0 (CFU × 10(8)g(-1)) and actinomycetes 410.0-2962.0 (CFU × 10(5)g(-1)) than initial material. Vermicomposted material was rich in plant-available forms of nutrients (N-NO(3)(-),PO(4)(3-),available K and SO(4)(-2)). Results suggested that noxious industrial waste can be converted into valuable product for sustainable soil fertility programme. Copyright © 2012 Elsevier Ltd. All rights reserved.
The Pharmaceutical Industry Beamline of Pharmaceutical Consortium for Protein Structure Analysis
International Nuclear Information System (INIS)
Nishijima, Kazumi; Katsuya, Yoshio
2002-01-01
The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)
Materials processing using supercritical fluids
Directory of Open Access Journals (Sweden)
Orlović Aleksandar M.
2005-01-01
Full Text Available One of the most interesting areas of supercritical fluids applications is the processing of novel materials. These new materials are designed to meet specific requirements and to make possible new applications in Pharmaceuticals design, heterogeneous catalysis, micro- and nano-particles with unique structures, special insulating materials, super capacitors and other special technical materials. Two distinct possibilities to apply supercritical fluids in processing of materials: synthesis of materials in supercritical fluid environment and/or further processing of already obtained materials with the help of supercritical fluids. By adjusting synthesis parameters the properties of supercritical fluids can be significantly altered which further results in the materials with different structures. Unique materials can be also obtained by conducting synthesis in quite specific environments like reversed micelles. This paper is mainly devoted to processing of previously synthesized materials which are further processed using supercritical fluids. Several new methods have been developed to produce micro- and nano-particles with the use of supercritical fluids. The following methods: rapid expansion of supercritical solutions (RESS supercritical anti-solvent (SAS, materials synthesis under supercritical conditions and encapsulation and coating using supercritical fluids were recently developed.
Single European currency and Monetary Union. Macroeconomic implications for pharmaceutical spending.
Kanavos, P
1998-01-01
This article examines the potential implications of introducing a single currency among the Member States of the European Union for national pharmaceutical prices and spending. In doing so, it provides a brief account of the direct effects of introducing a single currency on pharmaceutical business. These are static in nature and include the elimination of exchange rate volatility and transaction costs, increased price transparency and limited potential for parallel trade. It subsequently analyses the potential medium and long term macroeconomic policy choices facing the Member States and their impact on pharmaceutical spending following the introduction of a single currency. These include policy directions in order to meet the Maastricht convergence criteria in the run-up to forming an Economic and Monetary Union (EMU) and the implications of EMU on national macroeconomic policy thereafter. This article argues that the necessity for tight fiscal policies across the EU and, in particular, in those Member States facing high budget deficits and overall debt levels, will continue to exert considerable downward pressure on pharmaceutical spending.
Combinatorial nanodiamond in pharmaceutical and biomedical applications.
Lim, Dae Gon; Prim, Racelly Ena; Kim, Ki Hyun; Kang, Eunah; Park, Kinam; Jeong, Seong Hoon
2016-11-30
One of the newly emerging carbon materials, nanodiamond (ND), has been exploited for use in traditional electric materials and this has extended into biomedical and pharmaceutical applications. Recently, NDs have attained significant interests as a multifunctional and combinational drug delivery system. ND studies have provided insights into granting new potentials with their wide ranging surface chemistry, complex formation with biopolymers, and combination with biomolecules. The studies that have proved ND inertness, biocompatibility, and low toxicity have made NDs much more feasible for use in real in vivo applications. This review gives an understanding of NDs in biomedical engineering and pharmaceuticals, focusing on the classified introduction of ND/drug complexes. In addition, the diverse potential applications that can be obtained with chemical modification are presented. Copyright © 2016 Elsevier B.V. All rights reserved.
Vargas, Marco; Gadelha, Carlos Augusto Grabois; Costa, Laís Silveira; Maldonado, José
2012-12-01
Pharmaceutical and biotechnology industries comprise a major production subsystem of the health industrial complex in Brazil. It stands out for both its economic importance and its prominent role in developing new technologies in strategic areas. Strengthening the local production of generic drugs in the last decade has significantly increased the number of Brazilian companies in the local pharmaceutical market and has been an important turning point for this industry's growth. However, there remain major structural bottlenecks both in terms of production and continuous innovation. These bottlenecks reveal the high vulnerability of the Brazilian National Health System and point to the need of public policies that promote strengthening the production base and innovation in the pharmaceutical industry and that at the same time meet health-related social demands in health in Brazil.
Directory of Open Access Journals (Sweden)
Aldo De Ferrari
Full Text Available BACKGROUND: The interaction between physicians and the pharmaceutical industry influences physicians' attitudes and prescribing behavior. Although largely studied in the US, this topic has not been well studied in resource-poor settings, where a close relationship between physicians and industry still exists. OBJECTIVE: To describe physician interactions with and attitudes towards the pharmaceutical industry in a public general hospital in Lima, Peru. DESIGN: Descriptive, cross-sectional study through an anonymous, self-filled questionnaire distributed among faculty and trainee physicians of five different clinical departments working in a Peruvian public general hospital. A transcultural validation of an existing Spanish questionnaire was performed. Exposure to marketing activities, motivations to contact pharmaceutical representatives and attitudes towards industry were studied. Collected data was analyzed by degree of training, clinical department, gender and teaching status. Attitudes were measured on a four-point LIKERT scale. RESULTS: 155 physicians completed the survey, of which 148 were included in the study sample. 94.5% of attending physicians reported ongoing encounters with pharmaceutical representatives. The most common industry-related activities were receiving medical samples (91.2%, promotional material (87.8% and attending meetings in restaurants (81.8%. Respondents considered medical samples and continuing medical education the most ethically acceptable benefits. We found significant differences between attendings and residents, and teaching and non-teaching attendings. An association between the amount of encounters with pharmaceutical representatives, and attitudes towards industry and acceptance of medical samples was found. CONCLUSIONS: A close physician-industry relationship exists in the population under study. The contact is established mainly through pharmaceutical representatives. Medical samples are the most received
Design of experiments (DoE) in pharmaceutical development.
N Politis, Stavros; Colombo, Paolo; Colombo, Gaia; M Rekkas, Dimitrios
2017-06-01
At the beginning of the twentieth century, Sir Ronald Fisher introduced the concept of applying statistical analysis during the planning stages of research rather than at the end of experimentation. When statistical thinking is applied from the design phase, it enables to build quality into the product, by adopting Deming's profound knowledge approach, comprising system thinking, variation understanding, theory of knowledge, and psychology. The pharmaceutical industry was late in adopting these paradigms, compared to other sectors. It heavily focused on blockbuster drugs, while formulation development was mainly performed by One Factor At a Time (OFAT) studies, rather than implementing Quality by Design (QbD) and modern engineering-based manufacturing methodologies. Among various mathematical modeling approaches, Design of Experiments (DoE) is extensively used for the implementation of QbD in both research and industrial settings. In QbD, product and process understanding is the key enabler of assuring quality in the final product. Knowledge is achieved by establishing models correlating the inputs with the outputs of the process. The mathematical relationships of the Critical Process Parameters (CPPs) and Material Attributes (CMAs) with the Critical Quality Attributes (CQAs) define the design space. Consequently, process understanding is well assured and rationally leads to a final product meeting the Quality Target Product Profile (QTPP). This review illustrates the principles of quality theory through the work of major contributors, the evolution of the QbD approach and the statistical toolset for its implementation. As such, DoE is presented in detail since it represents the first choice for rational pharmaceutical development.
ECONOMIC AND FINANCIAL IMPLICATIONS OF THE PHARMACEUTICAL INDUSTRY IN ROMANIA
Directory of Open Access Journals (Sweden)
Georgiana Daniela Minculete Piko
2014-09-01
Full Text Available In the wake of the financial crisis, most industries witnessed an economic downturn also boosted by the austerity measures imposed by the state. The pharmaceutical sector is one of the few sectors that followed an upward trend. Although the economic and financial crisis has long taken hold of the entire world, the domino theory did not apply to this industry; instead, the “butterfly effect” became evident. The phrase refers to the fact that the wings of a butterfly create small changes that may finally alter the route of certain elements. In the pharmaceutical industry, minor changes in research and development finally led to spectacular innovations. At present, there are no such big investments in research and development in Romania as there are in Europe; yet, due to mergers and acquisitions between Romanian and foreign companies, the pharmaceutical sector in Romania significantly contributes to the creation of added value in terms of economic development. The added value of the pharmaceutical industry in our country has increased significantly in recent years. The purpose of this article is to highlight the financial and economic significance of the pharmaceutical industry in Romania. This industry is one with an average degree of concentration; thus, the average liquidity and solvency indicators in this sector were calculated with a view to emphasizing its financial independence. The findings of this research indicate a high level of financial independence in this industry, as pharmaceutical companies are able to meet payment deadlines. This study highlights the importance of such an industry in times of economic crisis, the financial stability of the pharmaceutical sector reinforcing the need for massive investment in research and development.
[Pharmaceutical product quality control and good manufacturing practices].
Hiyama, Yukio
2010-01-01
This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.
Meeting of socialist conntries' representatives on problems of nuclear materials analyses
International Nuclear Information System (INIS)
Pacak, P.; Moravec, J.; Krtil, J.; Sus, F.
1982-01-01
A meeting of representatives of the socialist countries was held in Prague from May 18 to 22, 1981, to discuss cooperation in the field of analytical control of nuclear materials. The Czechoslovak delegation informed the participants of the extent and results of the work of the Central Control Laboratory of the Nuclear Research Institute in Rez. A brief survey is given of the nondestructive methods of measuring the physical parameters of nuclear fuel, the methods of destructive determination of uranium and plutonium and the methods of preparation of standard materials for mass spectrometry which the Central Control Laboratory has introduced and verified for securing analytical control of nuclear materials. (B.S.)
Basic pharmaceutical technology
Angelovska, Bistra; Drakalska, Elena
2017-01-01
The lecture deals with basics of pharmaceutical technology as applied discipline of pharmaceutical science, whose main subject of study is formulation and manufacture of drugs. In a broad sense, pharmaceutical technology is science of formulation, preparation, stabilization and determination of the quality of medicines prepared in the pharmacy or in pharmaceutical industry
[Application of microwave irradiation technology to the field of pharmaceutics].
Zhang, Xue-Bing; Shi, Nian-Qiu; Yang, Zhi-Qiang; Wang, Xing-Lin
2014-03-01
Microwaves can be directly transformed into heat inside materials because of their ability of penetrating into any substance. The degree that materials are heated depends on their dielectric properties. Materials with high dielectric loss are more easily to reach a resonant state by microwaves field, then microwaves can be absorbed efficiently. Microwave irradiation technique with the unique heating mechanisms could induce drug-polymer interaction and change the properties of dissolution. Many benefits such as improving product quality, increasing energy efficiency and reducing times can be obtained by microwaves. This paper summarized characteristics of the microwave irradiation technique, new preparation techniques and formulation process in pharmaceutical industry by microwave irradiation technology. The microwave technology provides a new clue for heating and drying in the field of pharmaceutics.
Zhang, Hui-li; Xia, Yi; Hong, Zhi; Du, Yong
2015-07-01
Pharmaceutical cocrystal can improve physical and chemical properties of active pharmaceutical ingredient (API), meanwhile this feature has shown great potential in improving the pharmaceutical's properties and characteristics. In this study, cocrystal formation between piracetam and 3-hydroxybenzoic acid (3HBA) using grinding method has been characterized by Fourier transform infrared (FTIR), Raman and terahertz (THz) spectroscopical techniques. The vibrational modes of different motions are obtained by the assignment of the peaks in the spectra of the starting materials and the cocrystal components. FTIR, Raman and THz spectroscopical results show that the vibrational modes of the cocrystal are different from those of the starting materials. In addition, the dynamic process of the above cocrystal formation is investigated in-depth with Raman and THz spec- tra. Piracetam-3HBA cocrystal is formed pretty fast in first several minutes, and then the formation rate becomes slow. After 35 minutes, such formation process has been completed. The results offer the theoretical benchmark and unique means for real-time monitoring pharmaceutical cocrystal formation and also the corresponding quantitative analysis in the pharmaceutical field.
International Nuclear Information System (INIS)
Clark, R.E.H.
2001-11-01
The proceedings and conclusions of the 2nd Research Co-ordination Meeting on 'Plasma-Material Interaction Data for Mixed Plasma Facing Materials in Fusion Reactors', held on October 16 and 17, 2000 at the IAEA Headquarters in Vienna, are briefly described. This report includes a summary of the presentations made by the meeting participants and a review of the accomplishments of the Co-ordinated Research Project (CRP). In addition, short summaries from the participants are included indicating the specific research completed in support of this CRP. (author)
Effluent treatment plant for pharmaceutical unit at Bahipheru - case study
International Nuclear Information System (INIS)
Hayat, A.
1997-01-01
This project has been awarded to environ (Pvt) Ltd., on turnkey basis, and is an integrated waste treatment facility for pharmaceuticals companies, manufacturing paracetamole, aspirin and various pharmaceuticals intermediates, from phenol as basic raw material. A highly toxic waste water, containing high concentrations of phenolics and sulfate ions is generated at this plant and has to be treatment before final disposal into an irrigation channel. (author)
Specialists' meeting on high temperature metallic materials for application in gas-cooled reactors
International Nuclear Information System (INIS)
At the meeting overviews of current programmes for the development of high temperature materials in Japan, F.R. Germany and the United States of America were presented. Some papers were presented dealing with various aspects of microstructural studies, surface reactions and the changes of microstructure and dimensions due mainly to the associated interfacial material transports, protective surface coatings for HTGR and AGR applications. Other topics presented were mechanical properties of materials and also the influence of materials' properties data on design at temperatures in the creep region where time dependent behaviour must be considered
International Nuclear Information System (INIS)
2009-01-01
A series of presentations on the assessment of core structural components and materials at their facilities were given by the experts. The different issues related to degradation mechanisms were discussed. The outputs include a more thorough understanding of the specific challenges related to Research Reactors (RRs) as well as proposals for activities which could assist RR organizations in their efforts to address the issues involved. The experts recommend that research reactor operators consider implementation of surveillance programs for materials of core structural components, as part of ageing management program (TECDOC-792 and DS-412). It is recognised by experts that adequate archived structural material data is not available for many RRs. Access to this data and extension of existing material databases could help many operating organisations extend the operation of their RRs. The experts agreed that an IAEA Technical Meeting (TM) on Assessment of Core Structural Materials should be organised in December 2009 (IAEA HQ Vienna). The proposed objectives of the TM are: (i) exchange of detailed technical information on the assessment and ageing management of core structural materials, (ii) identification of materials of interest for further investigation, (iii) proposal for a new IAEA CRP on Assessment of Core Structural Materials, and (iv) identification of RRs prepared to participate in proposed CRP. Based on the response to a questionnaire prepared for the 2008 meeting of the Technical Working Group for Research Reactors, the number of engineering capital projects related to core structural components is proportionally lower than those related to,for example, I and C or electrical power systems. This implies that many operating research reactors will be operating longer using their original core structural components and justifies the assessment and evaluation programmes and activities proposed in this report. (author)
[New research on the significance of polymers in pharmaceutical formulations].
Amighi, K
2001-01-01
During these last few decades, a lot of work has been made in pharmaceutical area in order to control the drug delivery from various pharmaceutical dosage forms. The use of polymers in pharmaceutical technology have led to the development of the first drug delivery systems proposed in order to prolong or to delay the drug delivery, or to enhance drug release for drugs showing bioavailability shortcomings. The wide range of polymers available for pharmaceutical use, their low reactivity towards drugs and other formulation ingredients and their safe nature, have permitted a widespread use of polymers to improve manufacturing processes or for the formulation of pharmaceutical dosage forms for various administration routes. More over, the preparation of new polymeric materials by the synthesis of new polymers with unique properties or by the modification of available natural or synthetic polymers, offer to the formulator a wide range of applications in order to optimise the drug delivery for each specific case.
International Nuclear Information System (INIS)
Janev, R.K.; Federici, G.; Roth, J.
1999-07-01
The proceedings, conclusions and recommendations of the IAEA Advisory Group Meeting on 'Critical Assessment of Tritium Retention in Fusion Reactor Materials', held on June 7-8, 1999 at the IAEA Headquarters in Vienna, Austria, are briefly described. The report contains a summary of the presentations of meeting participants, a review of the data status (availability and needs) for the fusion most relevant bulk and mixed materials, and recommendations to the IAEA regarding its future activity in this data area. (author)
Measurement of residual stress in materials using neutrons. Proceedings of a technical meeting
International Nuclear Information System (INIS)
2005-06-01
One of the objectives of the IAEA's project on effective utilization of research reactors is to promote the use of the existing research reactors based on their capabilities and is implemented through workshops and technical meetings. Measurement of residual stress is one of the techniques that find wide applications in materials development and testing. The Technical Meeting on Measurement of Residual Stress Using Neutrons was organized to meet this objective. This publication is the outcome of the deliberations during the meeting and the presentations by the participants and is addressed to the research reactor managers, users and designers of facilities for reactor utilization. It will especially benefit those seeking to develop new facilities or upgrade the existing ones to enhance the utilization of their research reactors. Experts with a long experience in developing and using neutron beam instruments in high flux and medium flux research reactors participated in this technical meeting. They presented the design, development and utilization of the facilities at their respective centres and reviewed the current status of the residual stress measurements using neutron beams from research reactors. The sessions included brainstorming on the methodology and data analysis, characterization and standardization of the equipment and identifying the scope for further development. This publication refers to the determination of residual and/or applied stresses in polycrystalline materials using neutron diffraction technique. Stress is developed during the synthesis and use of materials such as alloys and compounds. Measurement of residual stress is essential to improve the quality of synthesized materials and diagnosis of failure and/or reliability of fabricated components. Neutron scattering has played an important role in studying structure and dynamics of condensed matter. Neutron scattering is a non-destructive technique and is useful for testing large samples. The
International Nuclear Information System (INIS)
2013-01-01
The objective of the Technical Meeting is to present and discuss innovative liquid metal fast reactor (LMFR) core designs with special focus on the choice, development, testing and qualification of advanced reactor core structural materials
Report on the material committee meetings in fiscal 1987; 1987 nendo zairyo iinkai hokokusho
Energy Technology Data Exchange (ETDEWEB)
NONE
1988-03-01
The material committee has held two meetings in this fiscal year. The first committee meeting (September 25, 1987) was held for the major agenda of (1) the development of a centrifugal slurry pump for liquefaction plants, and as the research and development in fiscal 1987, the in-plant tests on new materials and the development a let-down valve, which were reported and deliberated. The major agenda of the second committee meeting (February 24, 1988) were, as the summarized achievements in fiscal 1987, (2) development of a technology to manufacture hydrogen by utilizing coal, (3) in-plant tests on new materials, and (4) development of a let-down valve, which were reported and deliberated. In Item (1), wear in the shaft seal of the centrifugal slurry pump was discussed regarding its cause from the result of a contraction flow test. In Item (2), it was verified that picrochloromite and chromia are integrated as an electromelting aggregate for the atmospheric stability of refractories used in a gasification furnace, and that the test conditions for the refractories call for the refractories to be tested under severe conditions. In Item (3), how to proceed the tests in the future was verified on such items as corrosion patterns, tested materials, coal types, and the degree of corrosion. In Item (4), kinds and temperatures were verified on slurries used in the water-slurry wear test and the fretting corrosion test. (NEDO)
2012-03-20
... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration; Johnson Matthey, Inc., Pharmaceutical Materials By Notice dated December 2, 2011, and published in the Federal Register on December 12, 2011, 76 FR 77253, Johnson Matthey, Inc., Pharmaceutical...
Advanced Continuous Flow Platform for On-Demand Pharmaceutical Manufacturing.
Zhang, Ping; Weeranoppanant, Nopphon; Thomas, Dale A; Tahara, Kohei; Stelzer, Torsten; Russell, Mary Grace; O'Mahony, Marcus; Myerson, Allan S; Lin, Hongkun; Kelly, Liam P; Jensen, Klavs F; Jamison, Timothy F; Dai, Chunhui; Cui, Yuqing; Briggs, Naomi; Beingessner, Rachel L; Adamo, Andrea
2018-02-21
As a demonstration of an alternative to the challenges faced with batch pharmaceutical manufacturing including the large production footprint and lengthy time-scale, we previously reported a refrigerator-sized continuous flow system for the on-demand production of essential medicines. Building on this technology, herein we report a second-generation, reconfigurable and 25 % smaller (by volume) continuous flow pharmaceutical manufacturing platform featuring advances in reaction and purification equipment. Consisting of two compact [0.7 (L)×0.5 (D)×1.3 m (H)] stand-alone units for synthesis and purification/formulation processes, the capabilities of this automated system are demonstrated with the synthesis of nicardipine hydrochloride and the production of concentrated liquid doses of ciprofloxacin hydrochloride, neostigmine methylsulfate and rufinamide that meet US Pharmacopeia standards. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.
Access to medicines: relations with the institutionalization of pharmaceutical services
Directory of Open Access Journals (Sweden)
Rafael Damasceno de Barros
2017-11-01
Full Text Available ABSTRACT OBJETIVE To analyze the relationship between access to medicines by the population and the institutionalization of pharmaceutical services in Brazilian primary health care. METHODS This study is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services 2015, a cross-sectional, exploratory, and evaluative study composed of an information survey in a representative sample of cities, stratified by Brazilian regions. Access was defined based on the acquisition of medicines reported by the patient, ranging between: total, partial, or null. The institutionalization of pharmaceutical services was analyzed based on information provided by pharmaceutical services providers and by those responsible for medicines delivery. Chi-square test and multinomial logistic regression were used in the statistical analysis. RESULTS Full access to medicines was greater when professionals affirmed there were the following aspects of the dimensions: “management tools,” “participation and social control,” “financing,” and “personnel structure,” with significant associations in the bivariate analysis. The “pharmaceutical care” dimension did not achieve such an association. After multinomial logistic regression, full access was more prevalent when those in charge of pharmaceutical services stated that: they always or repeatedly attend meetings of the Municipal Health Council, OR = 3.3 (95%CI 1.5-7.3; there are protocols for medicines delivery, OR = 2.7 (95%CI 1.2-6.1; there is computerized system for managing pharmaceutical services, OR = 3.9 (95%CI 1.9-8.0; those responsible for medicines delivery reported having participated in a course or training for professionals in the past two years, OR = 2.0 (95%CI 1.1-3.5; there is computerized system for pharmaceutical services management, OR
A survey of pharmaceutical company representative interactions with doctors in Libya
Directory of Open Access Journals (Sweden)
Mustafa A. Alssageer
2012-09-01
Full Text Available Objectives: To examine the frequency of pharmaceutical company representative (PCR interactions with doctors in Libya and review possible associations between these interactions and the personal and practice setting characteristics of doctors. Method: An anonymous survey questionnaire was circulated to 1,000 Libyan doctors in selected public and private practice settings in Tripoli, Benghazi and Sebha. Results: A questionnaire return rate of 61% (608 returned questionnaires was achieved. Most respondents (94% reported that they had been visited by PCRs at least ‘once’ in the last year. Fifty per cent of respondents met with PCRs at least once a month, and 20% at least once a week. The following characteristics were significantly associated with meeting with a representative more than once a week: age, gender (male > female, years of practice, being a specialist (other than an anaesthesiologist or working in private practice. Ninety-one per cent of doctors reported that they had received at least one kind of relationship gift during the last year. Printed materials (79%, simple gifts (73% and drug samples (69% were the most common relationship products given to respondents. Reimbursements or sponsored items were reported by 33% of respondents. Physician specialists were more likely to receive drug samples or sponsored items than residents, general practitioners, anaesthesiologists or surgeons (P<0.01. Participants working in private practice alone or in both sectors were more likely to receive printed materials, simple gifts or free samples from PCRs than doctors working in the public sector (P<0.05. Conclusion: Libyan doctors are frequently visited by PCRs. Doctors, working in private practice or specialist practice, are especially targeted by promotional activities. An agreed code of conduct for pharmaceutical promotion in Libya between doctors and PCRs should be created.
International Nuclear Information System (INIS)
1999-01-01
The purpose of this Consultant's Meeting report was to provide basic guidelines to the analysts involved in IAEA certification analysis for IAEA-392 and IAEA-393 Algae Reference Materials and to harmonise the analytical approach. The experience of this exercise will be combined with the requirements of ISO Guide 34 and 35 and should be the basis for a planned guide book on this topic. The Meeting was focused on on the practical implementation of the quality requirements for Reference Material analysis and certification procedures from ISO Guide 34 and ISO Guide 35
Development of Problem Sets for K-12 and Engineering on Pharmaceutical Particulate Systems
Savelski, Mariano J.; Slater, C. Stewart; Del Vecchio, Christopher A.; Kosteleski, Adrian J.; Wilson, Sarah A.
2010-01-01
Educational problem sets have been developed on structured organic particulate systems (SOPS) used in pharmaceutical technology. The sets present topics such as particle properties and powder flow and can be integrated into K-12 and college-level curricula. The materials educate students in specific areas of pharmaceutical particulate processing,…
International Nuclear Information System (INIS)
2010-10-01
The economics of current nuclear power plants have improved through increased fuel burnup and longer fuel cycles, i.e. increasing the effective time that fuel remains in the reactor core and the amount of energy it generates. Efficient consumption of fissile material in the fuel element before it is discharged from the reactor means that less fuel is required over the reactor's life cycle, which results in lower amounts of fresh fuel, lower spent fuel storage costs, and less waste for ultimate disposal. Better utilization of fissile nuclear materials, as well as more flexible power manoeuvring, place challenging operational demands on materials used in reactor components, and first of all, on fuel and cladding materials. It entails increased attention to measures ensuring desired in-pile fuel performance parameters that require adequate improvements in fuel material properties and fuel rod designs. These are the main reasons that motivated the IAEA Technical Working Group on Fuel Performance and Technology (TWG-FPT) to recommend the organization of a Technical Committee Meeting on Advanced Fuel Pellet Materials and Fuel Rod Designs for Power Reactors. The proposal was supported by the IAEA TWGs on Advanced Technologies for Light and Heavy Water-Cooled Reactors (TWG-LWR and TWG-HWR), and the meeting was held at the invitation of the Government of Switzerland at the Paul Scherrer Institute in Villigen, from 23 to 26 November 2009. This was the third IAEA meeting on these subjects (the first was held in 1996 in Tokyo, Japan, and the second in 2003 in Brussels, Belgium), which reflects the continuous interest in the above issues among Member States. The purpose of the meeting was to review the current status in the development of fuel pellet materials and to explore recent improvements in fuel rod designs for light and heavy water cooled power reactors. The meeting was attended by 45 specialists representing fuel vendors, nuclear utilities, research and development
Core competencies for pharmaceutical physicians and drug development scientists
Silva, Honorio; Stonier, Peter; Buhler, Fritz; Deslypere, Jean-Paul; Criscuolo, Domenico; Nell, Gerfried; Massud, Joao; Geary, Stewart; Schenk, Johanna; Kerpel-Fronius, Sandor; Koski, Greg; Clemens, Norbert; Klingmann, Ingrid; Kesselring, Gustavo; van Olden, Rudolf; Dubois, Dominique
2013-01-01
Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes (LO) of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain LO anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide. PMID:23986704
Influence of pharmaceutical marketing on prescription practices of physicians.
Narendran, Roshni; Narendranathan, M
2013-01-01
In India same drug molecules are sold under different brand names by different pharmaceuticals. To persuade the physicians to prescribe their brands pharmaceuticals engage in marketing techniques like giving samples, gifts, sponsoring travel etc. Many countries are striving to reduce the impact of incentives on prescription behaviour. This study explores the influence of pharmaceutical marketing on the prescription practices of doctors in India. There were 103 study subjects - 50 doctors and 53 sales personnel. Data collection was done by a self administered questionnaire. Data were collected on 36 variables which were supposed to influence prescription. The effectiveness of the promotional strategies on prescription behaviour was marked in a seven point Likert scale ranging from "not at all effective" (score=1) to "extremely effective" (score=7). Open ended questions were used to collect qualitative data. Good rapport with the doctor, launch meetings, reputation of the company, quality of the drug and brand names significantly influenced prescription behaviour, while direct mailers, advertisements in journals and giving letter pads and other brand reminders were less effective. Commonly used method of giving samples was not among the twenty most effective methods influencing prescription. Product quality and good company are still factors that influence prescription. Pharmaceutical marketing influences the choice of brands by a physician. The more expensive strategies involved in public relations are more effective. Sending mails and journal advertisements are less effective strategies. How expensive marketing strategies affect cost of the medicines has to be explored further.
Core Competencies for Pharmaceutical Physicians and Drug Development Scientists
Directory of Open Access Journals (Sweden)
Honorio eSilva
2013-08-01
Full Text Available Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine, are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain Learning Outcomes anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide.
Evans, David V; Keys, Toby; Desnick, Laurel; A Andrilla, C Holly; Bienz, Danielle; Rosenblatt, Roger
2016-07-01
Pharmaceutical marketing techniques are effective in changing the behavior of health care providers in ways that deviate from evidence-based practices. To mitigate the influence of pharmaceutical marketing on learners, academic medical centers (AMCs) have adopted policies to limit student/industry interaction. Many clinical experiences occur outside of the AMC. The purpose of this study was to compare medical students' exposure to pharmaceutical marketing in off-campus rural and urban underserved clinical sites. The University of Washington School of Medicine Rural and Underserved Opportunities Program (RUOP) places rising second-year medical students in underserved clinical sites in five northwestern states. We surveyed RUOP students to evaluate their exposure to pharmaceutical marketing. Of 120 students, 86 (72%) completed surveys. Sixty-five (76%) did their RUOP rotation in rural areas. Students in rural locations were more likely to report exposure to pharmaceutical marketing. Distribution of free drug samples was reportedly three times higher in rural than urban sites (54% versus 15%). Doctors meeting with sales representatives were reported as four times higher in rural clinics (40% versus 10%). Students at rural sites reported exposure to pharmaceutical marketing more than those in urban settings. Rural medical educators should provide faculty development for community clinicians on the influences of pharmaceutical marketing on learners. Medical schools must review local clinic and institution-wide policies to limit pharmaceutical marketing exposure to learners in the rural learning environment.
Management of pharmaceutical services in the Brazilian primary health care.
Gerlack, Letícia Farias; Karnikowski, Margô Gomes de Oliveira; Areda, Camila Alves; Galato, Dayani; Oliveira, Aline Gomes de; Álvares, Juliana; Leite, Silvana Nair; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Costa, Karen Sarmento; Guerra, Augusto Afonso; Acurcio, Francisco de Assis
2017-11-13
To identify limiting factors in the management of pharmaceutical services in the primary health care provided by the Brazilian Unified Health System (SUS). This study was based on the data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines), and it was conducted by interviews with professionals responsible for pharmaceutical services in Brazilian cities, in 2015. To identify the management limiting factors, we considered the organizational, operational, and sustainability indicators of the management. For the analyses, we included the weights and structure of analysis plan for complex samples. The results were expressed by frequencies and measures of central tendency with 95% confidence interval, considering the Brazilian geographic regions. We identified the following limiting factors: lack of pharmaceutical services in the Municipal Health Secretariat organization chart (24%) and in the health plan (18%); lack of participation of managers in the Health Board and the absence of reference to this topic in the agenda of meetings (58.4%); lack of financial autonomy (61.5%) and lack of knowledge on the available values (81.7%); lack of adoption of operational procedures (about 50%) for selection, scheduling, and acquisition; and the fact that most professionals evaluate the organization of pharmaceutical services as good and great (58.8%), despite the worrisome indicators. Pharmaceutical services management is currently supported by a legal and political framework that should guide and contribute to improve the pharmaceutical services in the Brazilian Unified Health System primary health care. However, there is a mismatch between the goals established by these guidelines and what is actually happening.
PREFACE: 2nd International Meeting for Researchers in Materials and Plasma Technology
Niño, Ely Dannier V.
2013-11-01
These proceedings present the written contributions of the participants of the 2nd International Meeting for Researchers in Materials and Plasma Technology, 2nd IMRMPT, which was held from February 27 to March 2, 2013 at the Pontificia Bolivariana Bucaramanga-UPB and Santander and Industrial - UIS Universities, Bucaramanga, Colombia, organized by research groups from GINTEP-UPB, FITEK-UIS. The IMRMPT, was the second version of biennial meetings that began in 2011. The three-day scientific program of the 2nd IMRMPT consisted in 14 Magisterial Conferences, 42 Oral Presentations and 48 Poster Presentations, with the participation of undergraduate and graduate students, professors, researchers and entrepreneurs from Colombia, Russia, France, Venezuela, Brazil, Uruguay, Argentina, Peru, Mexico, United States, among others. Moreover, the objective of IMRMPT was to bring together national and international researchers in order to establish scientific cooperation in the field of materials science and plasma technology; introduce new techniques of surface treatment of materials to improve properties of metals in terms of the deterioration due to corrosion, hydrogen embrittlement, abrasion, hardness, among others; and establish cooperation agreements between universities and industry. The topics covered in the 2nd IMRMPT include New Materials, Surface Physics, Laser and Hybrid Processes, Characterization of Materials, Thin Films and Nanomaterials, Surface Hardening Processes, Wear and Corrosion / Oxidation, Modeling, Simulation and Diagnostics, Plasma Applications and Technologies, Biomedical Coatings and Surface Treatments, Non Destructive Evaluation and Online Process Control, Surface Modification (Ion Implantation, Ion Nitriding, PVD, CVD). The editors hope that those interested in the are of materials science and plasma technology, enjoy the reading that reflect a wide range of topics. It is a pleasure to thank the sponsors and all the participants and contributors for
Nano spray drying for encapsulation of pharmaceuticals.
Arpagaus, Cordin; Collenberg, Andreas; Rütti, David; Assadpour, Elham; Jafari, Seid Mahdi
2018-05-17
Many pharmaceuticals such as pills, capsules, or tablets are prepared in a dried and powdered form. In this field, spray drying plays a critical role to convert liquid pharmaceutical formulations into powders. In addition, in many cases it is necessary to encapsulate bioactive drugs into wall materials to protect them against harsh process and environmental conditions, as well as to deliver the drug to the right place and at the correct time within the body. Thus, spray drying is a common process used for encapsulation of pharmaceuticals. In view of the rapid progress of nanoencapsulation techniques in pharmaceutics, nano spray drying is used to improve drug formulation and delivery. The nano spray dryer developed in the recent years provides ultrafine powders at nanoscale and high product yields. In this paper, after explaining the concept of nano spray drying and understanding the key elements of the equipment, the influence of the process parameters on the final powders properties, like particle size, morphology, encapsulation efficiency, drug loading and release, will be discussed. Then, numerous application examples are reviewed for nano spray drying and encapsulation of various drugs in the early stages of product development along with a brief overview of the obtained results and characterization techniques. Copyright © 2018 Elsevier B.V. All rights reserved.
Chitin and Chitosan as Direct Compression Excipients in Pharmaceutical Applications
Badwan, Adnan A.; Rashid, Iyad; Al Omari, Mahmoud M.H.; Darras, Fouad H.
2015-01-01
Despite the numerous uses of chitin and chitosan as new functional materials of high potential in various fields, they are still behind several directly compressible excipients already dominating pharmaceutical applications. There are, however, new attempts to exploit chitin and chitosan in co-processing techniques that provide a product with potential to act as a direct compression (DC) excipient. This review outlines the compression properties of chitin and chitosan in the context of DC pharmaceutical applications. PMID:25810109
Chitin and Chitosan as Direct Compression Excipients in Pharmaceutical Applications
Directory of Open Access Journals (Sweden)
Adnan A. Badwan
2015-03-01
Full Text Available Despite the numerous uses of chitin and chitosan as new functional materials of high potential in various fields, they are still behind several directly compressible excipients already dominating pharmaceutical applications. There are, however, new attempts to exploit chitin and chitosan in co-processing techniques that provide a product with potential to act as a direct compression (DC excipient. This review outlines the compression properties of chitin and chitosan in the context of DC pharmaceutical applications.
Energy Technology Data Exchange (ETDEWEB)
Bui, Tung Xuan [School of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of); Kang, Seo-Young [International Environmental Research Center (IERC), Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of); Lee, Sang-Hyup [Water Environment Center, Korea Institute of Science and Technology, Cheongryang, Seoul 130-650 (Korea, Republic of); Choi, Heechul, E-mail: hcchoi@gist.ac.kr [School of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of)
2011-10-15
Highlights: {yields} SBA-15 grafted with aminopropyl, hydroxymethyl, and trimethylsilyl groups as sorbents. {yields} Sorbents for removal of a mixture of 12 pharmaceuticals from water. {yields} Hydroxymethyl-SBA-15 shows similar adsorption efficiency like SBA-15. {yields} Aminopropyl-SBA-15 makes increase for clofibric acid, diclofenac, decrease for atenolol, estrone, trimethoprim. {yields} Trimethylsilyl-SBA-15 makes increase for 9 compounds; 7 compounds from 70.6% to 98.9%. - Abstract: Mesoporous silica SBA-15 and its postfunctionalized counterparts with hydroxymethyl (HM-SBA-15), aminopropyl (AP-SBA-15), and trimethylsilyl (TMS-SBA-15) were prepared and characterized by powder X-ray diffraction, N{sub 2} adsorption-desorption measurement, Fourier-transform infrared spectroscopy, and elemental analysis. The removal of a mixture of 12 selected pharmaceuticals was investigated by batch adsorption experiments onto SBA-15 and the grafted materials. SBA-15 showed to have moderate adsorption affinity with amino-containing (atenolol, trimethoprim) and hydrophobic pharmaceuticals, but it displayed minimal adsorption affinity toward hydrophilic compounds. HM-SBA-15 was analogous with SBA-15 in terms of the adsorption efficiency toward all pharmaceuticals. AP-SBA-15 exhibited an increase in the adsorption of two acidic compounds (clofibric acid, diclofenac) but a decrease in the adsorption of estrone and the two amino-containing compounds. Among the grafted materials, TMS-SBA-15 had the highest adsorption affinity toward most pharmaceuticals. Moreover, the adsorption of nine pharmaceuticals to TMS-SBA-15 was significantly higher than that to SBA-15; seven of which showed the removal percentages from 70.6% to 98.9% onto TMS-SBA-15. The number of pharmaceuticals showing high adsorption efficiency onto TMS-SBA-15 did not alter significantly as the pH changed in the range of 5.5-7.6. The results suggest that TMS-SBA-15 is a promising material for the removal of pharmaceuticals
International Nuclear Information System (INIS)
Bui, Tung Xuan; Kang, Seo-Young; Lee, Sang-Hyup; Choi, Heechul
2011-01-01
Highlights: → SBA-15 grafted with aminopropyl, hydroxymethyl, and trimethylsilyl groups as sorbents. → Sorbents for removal of a mixture of 12 pharmaceuticals from water. → Hydroxymethyl-SBA-15 shows similar adsorption efficiency like SBA-15. → Aminopropyl-SBA-15 makes increase for clofibric acid, diclofenac, decrease for atenolol, estrone, trimethoprim. → Trimethylsilyl-SBA-15 makes increase for 9 compounds; 7 compounds from 70.6% to 98.9%. - Abstract: Mesoporous silica SBA-15 and its postfunctionalized counterparts with hydroxymethyl (HM-SBA-15), aminopropyl (AP-SBA-15), and trimethylsilyl (TMS-SBA-15) were prepared and characterized by powder X-ray diffraction, N 2 adsorption-desorption measurement, Fourier-transform infrared spectroscopy, and elemental analysis. The removal of a mixture of 12 selected pharmaceuticals was investigated by batch adsorption experiments onto SBA-15 and the grafted materials. SBA-15 showed to have moderate adsorption affinity with amino-containing (atenolol, trimethoprim) and hydrophobic pharmaceuticals, but it displayed minimal adsorption affinity toward hydrophilic compounds. HM-SBA-15 was analogous with SBA-15 in terms of the adsorption efficiency toward all pharmaceuticals. AP-SBA-15 exhibited an increase in the adsorption of two acidic compounds (clofibric acid, diclofenac) but a decrease in the adsorption of estrone and the two amino-containing compounds. Among the grafted materials, TMS-SBA-15 had the highest adsorption affinity toward most pharmaceuticals. Moreover, the adsorption of nine pharmaceuticals to TMS-SBA-15 was significantly higher than that to SBA-15; seven of which showed the removal percentages from 70.6% to 98.9% onto TMS-SBA-15. The number of pharmaceuticals showing high adsorption efficiency onto TMS-SBA-15 did not alter significantly as the pH changed in the range of 5.5-7.6. The results suggest that TMS-SBA-15 is a promising material for the removal of pharmaceuticals from aqueous phase
Mangal, Sharad; Meiser, Felix; Morton, David; Larson, Ian
2015-01-01
Tablets represent the preferred and most commonly dispensed pharmaceutical dosage form for administering active pharmaceutical ingredients (APIs). Minimizing the cost of goods and improving manufacturing output efficiency has motivated companies to use direct compression as a preferred method of tablet manufacturing. Excipients dictate the success of direct compression, notably by optimizing powder formulation compactability and flow, thus there has been a surge in creating excipients specifically designed to meet these needs for direct compression. Greater scientific understanding of tablet manufacturing coupled with effective application of the principles of material science and particle engineering has resulted in a number of improved direct compression excipients. Despite this, significant practical disadvantages of direct compression remain relative to granulation, and this is partly due to the limitations of direct compression excipients. For instance, in formulating high-dose APIs, a much higher level of excipient is required relative to wet or dry granulation and so tablets are much bigger. Creating excipients to enable direct compression of high-dose APIs requires the knowledge of the relationship between fundamental material properties and excipient functionalities. In this paper, we review the current understanding of the relationship between fundamental material properties and excipient functionality for direct compression.
International Nuclear Information System (INIS)
1995-07-01
To obtain an overall picture of the current usage of control materials, research under way on new materials and to identify areas where materials are necessary to improve the safety, reliability and/or economics of water reactors, the IAEA convened a Technical Committee Meeting on Advances in Control Materials for Water Reactors. This meeting was recommended by the International Working Group on Fuel Performance and Technology and was held in Vienna from 29 November to 2 December 1993. Twenty-seven participants from twelve different countries attended the meeting and twelve papers were presented and are reproduced in these proceedings together with a summary of the meeting. A separate abstract was prepared for each of the papers. Refs, figs and tabs
Cracking in LWR RPV head penetrations. Working material. Proceedings of a specialists meeting
International Nuclear Information System (INIS)
1995-01-01
The IAEA Specialists' Meeting on Cracking in LWR RPV Head Penetrations was held at the ASTM Headquarters, Philadelphia, Pennsylvania, on May 2-4, 1995. It was attended by 39 participants from 12 countries. The meeting was held in the framework of the IAEA International Working Group on Life Management of Nuclear Power Plants (IWG-LMNPP) and was organized and sponsored by the Oak Ridge National Laboratory and the U.S. Nuclear Regulatory Commission. The purpose of the meeting was to review experience in the field for ensuring adequate performance of reactor pressure vessel (RPV) heads and penetrations. Presentations were aimed at achieving a better understanding of the behaviour of reactor component materials, providing guidance and recommendations to assure reliability and adequate performance, and proposing directions for further investigations. Refs, figs and tabs
Cracking in LWR RPV head penetrations. Working material. Proceedings of a specialists meeting
Energy Technology Data Exchange (ETDEWEB)
NONE
1996-12-31
The IAEA Specialists` Meeting on Cracking in LWR RPV Head Penetrations was held at the ASTM Headquarters, Philadelphia, Pennsylvania, on May 2-4, 1995. It was attended by 39 participants from 12 countries. The meeting was held in the framework of the IAEA International Working Group on Life Management of Nuclear Power Plants (IWG-LMNPP) and was organized and sponsored by the Oak Ridge National Laboratory and the U.S. Nuclear Regulatory Commission. The purpose of the meeting was to review experience in the field for ensuring adequate performance of reactor pressure vessel (RPV) heads and penetrations. Presentations were aimed at achieving a better understanding of the behaviour of reactor component materials, providing guidance and recommendations to assure reliability and adequate performance, and proposing directions for further investigations. Refs, figs and tabs.
Use of atypical antipsychotics in nursing homes and pharmaceutical marketing.
Pimentel, Camilla B; Donovan, Jennifer L; Field, Terry S; Gurwitz, Jerry H; Harrold, Leslie R; Kanaan, Abir O; Lemay, Celeste A; Mazor, Kathleen M; Tjia, Jennifer; Briesacher, Becky A
2015-02-01
To describe the current extent and type of pharmaceutical marketing in nursing homes (NHs) in one state and to provide preliminary evidence for the potential influence of pharmaceutical marketing on the use of atypical antipsychotics in NHs. Nested mixed-methods, cross-sectional study of NHs in a cluster randomized trial. Forty-one NHs in Connecticut. NH administrators, directors of nursing, and medical directors (n = 93, response rate 75.6%). Quantitative data, including prescription drug dispensing data (September 2009-August 2010) linked with Nursing Home Compare data (April 2011), were used to determine facility-level prevalence of atypical antipsychotic use, facility-level characteristics, NH staffing, and NH quality. Qualitative data, including semistructured interviews and surveys of NH leaders conducted in the first quarter of 2011, were used to determine encounters with pharmaceutical marketing. Leadership at 46.3% of NHs (n = 19) reported pharmaceutical marketing encounters, consisting of educational training, written and Internet-based materials, and sponsored training. No association was detected between level of atypical antipsychotic prescribing and reports of any pharmaceutical marketing by at least one NH leader. NH leaders frequently encounter pharmaceutical marketing through a variety of ways, although the impact on atypical antipsychotic prescribing is unclear. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.
Pharmaceutical aerosols. Study of their gamma radiation sterilization
International Nuclear Information System (INIS)
Sebert, P.
1984-10-01
The gamma radiation sterilization of pharmaceutical aerosols was studied. The following topics were investigated: radiosterilization of nitrogen protoxide used as a propellant; radiosterilization of packaging materials (aluminium containers, plastics valves); radio-sterilization of excipients and active ingredients. Most of the investigated materials proved to be stable to irradiation (2,5 Mrads) from pharmacopoeial aspect. Stability tests of the preparations packaged showed no change in the parameters investigated [fr
Bridgeman, Devon; Corral, Javier; Quach, Ashley; Xian, Xiaojun; Forzani, Erica
2014-09-09
Using supported ionic-liquid membrane (SILM)-inspired methodologies, we have synthesized, characterized, and developed a humidity sensor by coating a liquid composite material onto a hygroscopic, porous substrate. Similar to pH paper, the sensor responds to the environment's relative humidity and changes color accordingly. The humidity indicator is prepared by casting a few microliters of low-toxicity reagents on a nontoxic substrate. The sensing material is a newly synthesized liquid composite that comprises a hygroscopic medium for environmental humidity capture and a color indicator that translates the humidity level into a distinct color change. Sodium borohydride was used to form a liquid composite medium, and DenimBlu30 dye was used as a redox indicator. The liquid composite medium provides a hygroscopic response to the relative humidity, and DenimBlu30 translates the chemical changes into a visual change from yellow to blue. The borate-redox dye-based humidity sensor was prepared, and then Fourier transform infrared spectroscopy, differential scanning calorimetry, and image analysis methods were used to characterize the chemical composition, optimize synthesis, and gain insight into the sensor reactivity. Test results indicated that this new sensing material can detect relative humidity in the range of 5-100% in an irreversible manner with good reproducibility and high accuracy. The sensor is a low-cost, highly sensitive, easy-to-use humidity indicator. More importantly, it can be easily packaged with products to monitor humidity levels in pharmaceutical and food packaging.
Radiation protection in the pharmaceutical-chemical industry
International Nuclear Information System (INIS)
Griesser, R.
1992-01-01
Some aspects of the use of ionizing radiation in research in the pharmaceutical and chemical industries will be discussed, the emphasis being placed on the handling of open radioactive materials in research laboratories. The compliance with official regulations and the preparation of company internal radiation protection regulations are described. 1 tab., 9 refs
Does brand differentiate pharmaceuticals?
Bednarik, Josef
2005-12-01
Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.
Scott, Tia-Marie; Phillips, Patrick J.; Kolpin, Dana W.; Colella, Kaitlyn M.; Furlong, Edward T.; Foreman, William T.; Gray, James L.
2018-01-01
Discharges from pharmaceutical manufacturing facilities (PMFs) previously have been identified as important sources of pharmaceuticals to the environment. Yet few studies are available to establish the influence of PMFs on the pharmaceutical source contribution to wastewater treatment plants (WWTPs) and waterways at the national scale. Consequently, a national network of 13 WWTPs receiving PMF discharges, six WWTPs with no PMF input, and one WWTP that transitioned through a PMF closure were selected from across the United States to assess the influence of PMF inputs on pharmaceutical loading to WWTPs. Effluent samples were analyzed for 120 pharmaceuticals and pharmaceutical degradates. Of these, 33 pharmaceuticals had concentrations substantially higher in PMF-influenced effluent (maximum 555,000 ng/L) compared to effluent from control sites (maximum 175 ng/L). Concentrations in WWTP receiving PMF input are variable, as discharges from PMFs are episodic, indicating that production activities can vary substantially over relatively short (several months) periods and have the potential to rapidly transition to other pharmaceutical products. Results show that PMFs are an important, national-scale source of pharmaceuticals to the environment.
Pharmaceutical load in sewage sludge and biochar produced by hydrothermal carbonization.
vom Eyser, C; Palmu, K; Schmidt, T C; Tuerk, J
2015-12-15
We investigated the removal of twelve pharmaceuticals in sewage sludge by hydrothermal carbonization (HTC), which has emerged as a technology for improving the quality of organic waste materials producing a valuable biochar material. In this study, the HTC converted sewage sludge samples to a biochar product within 4h at a temperature of 210 °C and a resulting pressure of about 15 bar. Initial pharmaceutical load of the sewage sludge was investigated as well as the residual concentrations in biochar produced from spiked and eight native sewage sludge samples from three waste water treatment plants. Additionally, the solid contents of source material and product were compared, which showed a considerable increase of the solid content after filtration by HTC. All pharmaceuticals except sulfamethoxazole, which remained below the limit of quantification, frequently occurred in the investigated sewage sludges in the μg/kg dry matter (DM) range. Diclofenac, carbamazepine, metoprolol and propranolol were detected in all sludge samples with a maximum concentration of 800 μg/kgDM for metoprolol. HTC was investigated regarding its contaminant removal efficiency using spiked sewage sludge. Pharmaceutical concentrations were reduced for seven compounds by 39% (metoprolol) to≥97% (carbamazepine). In native biochar samples the four compounds phenazone, carbamazepine, metoprolol and propranolol were detected, which confirmed that the HTC process can reduce the load of micropollutants. In contrast to the other investigated compounds phenazone concentration increased, which was further addressed in thermal behaviour studies including three structurally similar potential precursors. Copyright © 2015 Elsevier B.V. All rights reserved.
Challenges in Translational Development of Pharmaceutical Cocrystals.
Kale, Dnyaneshwar P; Zode, Sandeep S; Bansal, Arvind K
2017-02-01
The last 2 decades have witnessed increased research in the area of cocrystals resulting in deeper scientific understanding, increase in intellectual property landscape, and evolution in the regulatory environment. Pharmaceutical cocrystals have received significant attention as a new solid form on account of their ability to modulate poor physicochemical properties of drug molecules. However, pharmaceutical development of cocrystals could be challenging, thus limiting their translation into viable drug products. In the present commentary, the role of cocrystals in the modulation of material properties and challenges involved in the pharmaceutical development of cocrystals have been discussed. The major hurdles encountered in the development of cocrystals such as safety of coformers, unpredictable performance during dissolution and solubility in different media, difficulties in establishing in vitro-in vivo correlation, and polymorphism have been extensively discussed. The influence of selecting appropriate formulation and process design on these challenges has been discussed. Finally, a brief outline of cocrystals that are undergoing clinical development has also been presented. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
2015-03-26
materials like crystalline semiconductors, graphene , and composites, the materials discussed here could have a significant impact. This thesis investigates...diagnosis [124], crystallinity of pharmaceutical materials [125], materials diagnosis for restoration of paintings [126], and materials research [127...temperature dots and paint were placed on samples on the substrate. Temperature dots are typically used in the transportation of goods such as food in order
[Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].
Dzhalilova, K I
2009-11-01
Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.
Electrostatics of Pharmaceutical Aerosols for Pulmonary Delivery.
Lip Kwok, Philip Chi
2015-01-01
This paper provides a review on key research findings in the rapidly developing area of pharmaceutical aerosol electrostatics. Solids and liquids can become charged without electric fields, the former by contact or friction and the latter by flowing or spraying. Therefore, charged particles and droplets carrying net charges are produced from pharmaceutical inhalers (e.g. dry powder inhalers, metered dose inhalers, and nebulisers) due to the mechanical processes involved in aerosolisation. The charging depends on many physicochemical factors, such as formulation composition, solid state properties, inhaler material and design, and relative humidity. In silico, in vitro, and limited in vivo studies have shown that electrostatic charges may potentially influence particle deposition in the airways. However, the evidence is not yet conclusive. Furthermore, there are currently no regulatory requirements on the characterisation and control of the electrostatic properties of inhaled formulations. Besides the need for further investigations on the relationship between physicochemical factors and charging characteristics of the aerosols, controlled and detailed in vivo studies are also required to confirm whether charges can affect particle deposition in the airways. Since pharmaceutical aerosol electrostatics is a relatively new research area, much remains to be explored. Thus there is certainly potential for development. New findings in the future may contribute to the advancement of pharmaceutical aerosol formulations and respiratory drug delivery.
Bettina Schwarzer
1995-01-01
Despite the widely acknowledged importance information technology plays in multinational corporations, many companies lack an understanding of when and how to (re)organize global IS management. The issues of timing and organization of global IS management, however, seem to be of utmost importance in a company’s attempt to implement a new, global business strategy. Based on three case studies from the pharmaceutical industry, this paper analyzes the sequence in which business strategy, organ...
Glass formability in medium-sized molecular systems/pharmaceuticals. I. Thermodynamics vs. kinetics
Energy Technology Data Exchange (ETDEWEB)
Tu, Wenkang; Li, Xiangqian; Chen, Zeming; Liu, Ying Dan; Wang, Li-Min, E-mail: simone.capaccioli@unipi.it, E-mail: Limin-Wang@ysu.edu.cn [State Key Lab of Metastable Materials Science and Technology, and College of Materials Science and Engineering, Yanshan University, Qinhuangdao, Hebei 066004 (China); Labardi, Massimiliano [CNR-IPCF, Sede Secondaria Pisa, Largo Pontecorvo 3, I-56127 Pisa (Italy); Capaccioli, Simone, E-mail: simone.capaccioli@unipi.it, E-mail: Limin-Wang@ysu.edu.cn [CNR-IPCF, Sede Secondaria Pisa, Largo Pontecorvo 3, I-56127 Pisa (Italy); Department of Physics, Pisa University, Largo Bruno Pontecorvo 3, I-56127 Pisa (Italy); Paluch, M. [Institute of Physics, University of Silesia, Uniwersytecka 4, 40-007 Katowice (Poland)
2016-05-07
Scrutinizing critical thermodynamic and kinetic factors for glass formation and the glass stability of materials would benefit the screening of the glass formers for the industry of glassy materials. The present work aims at elucidating the factors that contribute to the glass formation by investigating medium-sized molecules of pharmaceuticals. Glass transition related thermodynamics and kinetics are performed on the pharmaceuticals using calorimetric, dielectric, and viscosity measurements. The characteristic thermodynamic and kinetic parameters of glass transition are found to reproduce the relations established for small-molecule glass formers. The systematic comparison of the thermodynamic and kinetic contributions to glass formation reveals that the melting-point viscosity is the crucial quantity for the glass formation. Of more interest is the finding of a rough correlation between the melting-point viscosity and the entropy of fusion normalized by the number of beads of the pharmaceuticals, suggesting the thermodynamics can partly manifest its contribution to glass formation via kinetics.
Glass formability in medium-sized molecular systems/pharmaceuticals. I. Thermodynamics vs. kinetics.
Tu, Wenkang; Li, Xiangqian; Chen, Zeming; Liu, Ying Dan; Labardi, Massimiliano; Capaccioli, Simone; Paluch, M; Wang, Li-Min
2016-05-07
Scrutinizing critical thermodynamic and kinetic factors for glass formation and the glass stability of materials would benefit the screening of the glass formers for the industry of glassy materials. The present work aims at elucidating the factors that contribute to the glass formation by investigating medium-sized molecules of pharmaceuticals. Glass transition related thermodynamics and kinetics are performed on the pharmaceuticals using calorimetric, dielectric, and viscosity measurements. The characteristic thermodynamic and kinetic parameters of glass transition are found to reproduce the relations established for small-molecule glass formers. The systematic comparison of the thermodynamic and kinetic contributions to glass formation reveals that the melting-point viscosity is the crucial quantity for the glass formation. Of more interest is the finding of a rough correlation between the melting-point viscosity and the entropy of fusion normalized by the number of beads of the pharmaceuticals, suggesting the thermodynamics can partly manifest its contribution to glass formation via kinetics.
Directory of Open Access Journals (Sweden)
Андрій Ігорович Бойко
2016-04-01
Full Text Available Aim. Implementation of pharmaceutical informatics methods in the system of pharmaceutical care for diabetes patients in Ukraine.Methods. System method was used for the analysis of status and reforming the pharmaceutical care for patients with diabetes; program-oriented management at informatization project realization; pharmaceutical informatics in the creation of computer pharmaceutical knowledge bases; methods of data synthesis and summarizing.Results. System analysis of the basic directions of reforming the pharmaceutical care for patients with diabetes in Ukraine was carried out. Ways of it’s of optimization were processed: establishment of specialized pharmacies with implementation of modern information technologies and special postgraduate education for pharmacists. Structure and information providing of computer knowledge base “Pharmaceutical care for patients with diabetes” was substantiated.Conclusion. Based on the regional project “Informatization of prescription antidiabetic drugs circulation in Ukraine” realization, the necessity of establishment of specialized pharmacies providing pharmaceutical care for patients with diabetes was substantiated. Ways for optimization of postgraduate education for pharmacists of the specialized pharmacies by implementation of special thematic improvement cycles were proceed. Computer knowledge base as an effective tool for optimization of pharmaceutical care for patients with diabetes was realized
Packaging and labeling of pharmaceutical products obtained from the internet.
Veronin, Michael
2011-02-15
For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping
Bulk characterization of pharmaceutical powders by low-pressure compression
DEFF Research Database (Denmark)
Sørensen, A.H.; Sonnergaard, Jørn; Hovgaard, L.
2005-01-01
Low-pressure compression of pharmaceutical powders using small amounts of sample (50 mg) was evaluated as an alternative to traditional bulk powder characterization by tapping volumetry. Material parameters were extrapolated directly from the compression data and by fitting with the Walker...
Energy Technology Data Exchange (ETDEWEB)
NONE
2000-02-01
The safe, reliable and economic operation of water cooled nuclear power reactors depends to a large extent upon the reliable operation of control assemblies for the regulation and shutdown of the reactors. These consist of neutron absorbing materials clad in stainless steel or zirconium based alloys, guide tubes and guide cards, and other structural components. Current designs have worked extremely well in normal conditions, but less than ideal behaviour limits the lifetimes of control materials, imposing an economic penalty which acts as a strong incentive to produce improved materials and designs that are more reliable. Neutron absorbing materials currently in use include the ceramic boron carbide, the high melting point metal hafnium and the low melting point complex alloy Ag-In-Cd. Other promising neutron absorbing materials, such as dysprosium titanate, are being evaluated in the Russian Federation. These control materials exhibit widely differing mechanical, physical and chemical properties, which must be understood in order to be able to predict the behaviour of control rod assemblies. Identification of existing failure mechanisms, end of life criteria and the implications of the gradual introduction of extended burnup, mixed oxide (MOX) fuels and more complex fuel cycles constitutes the first step in a search for improved materials and designs. In the early part of this decade, it was recognized by the International Working Group on Fuel Performance and Technology (IWGFPT) that international conferences, symposia and published reviews on the materials science aspects of control assemblies were few and far between. Consequently, the IWGFPT recommended that the IAEA should rectify this situation with a series of Technical Committee meetings (TCMs) devoted entirely to the materials aspects of reactor control assemblies. The first was held in 1993 and in the intervening five years considerable progress has been made. In bringing together experts in the
International Nuclear Information System (INIS)
2000-02-01
The safe, reliable and economic operation of water cooled nuclear power reactors depends to a large extent upon the reliable operation of control assemblies for the regulation and shutdown of the reactors. These consist of neutron absorbing materials clad in stainless steel or zirconium based alloys, guide tubes and guide cards, and other structural components. Current designs have worked extremely well in normal conditions, but less than ideal behaviour limits the lifetimes of control materials, imposing an economic penalty which acts as a strong incentive to produce improved materials and designs that are more reliable. Neutron absorbing materials currently in use include the ceramic boron carbide, the high melting point metal hafnium and the low melting point complex alloy Ag-In-Cd. Other promising neutron absorbing materials, such as dysprosium titanate, are being evaluated in the Russian Federation. These control materials exhibit widely differing mechanical, physical and chemical properties, which must be understood in order to be able to predict the behaviour of control rod assemblies. Identification of existing failure mechanisms, end of life criteria and the implications of the gradual introduction of extended burnup, mixed oxide (MOX) fuels and more complex fuel cycles constitutes the first step in a search for improved materials and designs. In the early part of this decade, it was recognized by the International Working Group on Fuel Performance and Technology (IWGFPT) that international conferences, symposia and published reviews on the materials science aspects of control assemblies were few and far between. Consequently, the IWGFPT recommended that the IAEA should rectify this situation with a series of Technical Committee meetings (TCMs) devoted entirely to the materials aspects of reactor control assemblies. The first was held in 1993 and in the intervening five years considerable progress has been made. In bringing together experts in the
Wu, Huiquan; Khan, Mansoor
2012-08-01
As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.
On the die compaction of powders used in pharmaceutics.
Aryanpour, Gholamreza; Farzaneh, Masoud
2018-07-01
Die compaction is widely used in the compaction of pharmaceutical powders (tableting). It is well known that the powder densification is a result of particle rearrangement and particle deformation. The former is considered to be the governing mechanism of densification in an initial stage of compaction and the latter is regarded as the governing mechanism in the compaction at the higher pressure range. As a more realistic assumption, one can consider that a simultaneous performance of both the rearrangement and deformation mechanisms takes place from the beginning of compaction. To mathematically formulate this assumption, a piston equation is presented where the material relative density is given as a function of the applied pressure on the powder. From the equation, it is possible to obtain the contribution of each mechanism to the material densification at each value of the applied pressure. In the continuation, the piston equation is applied to the tabletting of some pharmaceutical powders. These are the powders of Ascorbic Acid, Avicel ® PH 101, Avicel ® PH 301, Emcompress ® , Sodium Chloride, and Tablettose ® whose tableting results have been previously published in the literature. The results show the piston equation as a suitable approach to describe the tabletting of pharmaceutical powders.
Srivastava, Rajesh; Chandra, Ashish; Kumar, Girish
2004-01-01
The annual global pharmaceutical sales have grown over 466 billion dollars, almost 50% of which comes from North America. Among developing countries, India, with 16% of the world population, accounts for only a small percentage of the global pharmaceutical industry. Until recently, India has had virtually no pharmaceutical industry worth the name producing drugs from basic raw materials and it used to rely mostly on the imports from countries like the USA and England for all its requirements of drugs. On the other hand, India has seen a plethora of multinational pharmaceutical companies come and do business in India. This paper develops a matrix which provides a broad guidance to the mid- to large-size Indian pharmaceutical domestic companies, which should embark on the path to global expansion to establish their might as well.
Li, Shuang; Li, Tao; Li, Jian-guo; Chen, Li; Ren, Jun; Li, Chao-lin
2012-02-01
To evaluate the comprehensive workplace health promotion intervention effect in a pharmaceutical company. The evaluation was conducted by using questionnaires, access to information, on-site surveys, satisfaction surveys and interviews. After the intervention, the awareness rate of the staff on "Occupational Disease Prevention Law", occupational disease prevention measures, the definition of hypertension, HIV transmission and high blood pressure, coronary heart disease preventive measures, have been raised from 72.4%, 13.8%, 67.5%, 45.8%, 51.7% to 97.8%, 19.9%, 82.3%, 94.7%, 53.1% respectively. The lifestyle of the staff has been improved, the improvement rate of smoking, drinking, having breakfast 4 times a week and above are 98.5%, 70.2% and 30.6% separately. Out of the 47 evaluation indicators, 41 meet the requirements, 5 basically meet the requirements. After implementing workplace health promotion activities, the level of occupational safety and health management of the pharmaceutical company has been enhanced, the physical and mental health of the staff have been promoted. The WHP comprehensive interventions are feasible and effective.
Third working meeting on radiation interaction. 1
International Nuclear Information System (INIS)
Schmidt, J.; Brede, O.; Doellstaedt, R.; Mehnert, R.
1984-12-01
The following topics have been discussed during the meeting: elementary processes in radiation chemistry and physics (theory, inorganic and organic systems); applied radiation chemistry and radiation processing; techniques, methods and instrumentation used in radiation chemistry and radiation processing; and irradiation of food, agricultural products, pharmaceutical products, domestic and industrial wastes. 52 papers are included in part 1
Third working meeting on radiation interaction. 2
International Nuclear Information System (INIS)
Schmidt, J.; Brede, O.; Doellstaedt, R.; Mehnert, R.
1984-12-01
The following topics have been discussed during the meeting: elementary processes in radiation chemistry and physics (theory, inorganic and organic systems); applied radiation chemistry and radiation processing; techniques, methods and instrumentation used in radiation chemistry and radiation processing; and irradiation of food, agricultural products, pharmaceutical products, domestic and industrial wastes. 55 papers are included in part 2
Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers
Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...
Horizon Scanning for Pharmaceuticals
DEFF Research Database (Denmark)
Lepage-Nefkens, Isabelle; Douw, Karla; Mantjes, GertJan
for a joint horizon scanning system (HSS). We propose to create a central “horizon scanning unit” to perform the joint HS activities (a newly established unit, an existing HS unit, or a third party commissioned and financed by the collaborating countries). The unit will be responsible for the identification...... and filtration of new and emerging pharmaceutical products. It will maintain and update the HS database, organise company pipeline meetings, and disseminate the HSS’s outputs. The HS unit works closely together with the designated national HS experts in each collaborating country. The national HS experts...... will collect country-specific information, liaise between the central HS unit and country-specific clinical and other experts, coordinate the national prioritization process (to select products for early assessment), and communicate the output of the HSS to national decision makers. The outputs of the joint...
Impact of pharmaceutical cocrystals: the effects on drug pharmacokinetics.
Shan, Ning; Perry, Miranda L; Weyna, David R; Zaworotko, Michael J
2014-09-01
Pharmaceutical cocrystallization has emerged in the past decade as a new strategy to enhance the clinical performance of orally administered drugs. A pharmaceutical cocrystal is a multi-component crystalline material in which the active pharmaceutical ingredient is in a stoichiometric ratio with a second compound that is generally a solid under ambient conditions. The resulting cocrystal exhibits different solid-state thermodynamics, leading to changes in physicochemical properties that offer the potential to significantly modify drug pharmacokinetics. The impact of cocrystallization upon drug pharmacokinetics has not yet been well delineated. Herein, we compile previously published data to address two salient questions: what effect does cocrystallization impart upon physicochemical properties of a drug substance and to what degree can those effects impact its pharmacokinetics. Cocrystals can impact various aspects of drug pharmacokinetics, including, but not limited to, drug absorption. The diversity of solid forms offered through cocrystallization can facilitate drastic changes in solubility and pharmacokinetics. Therefore, it is unsurprising that cocrystal screening is now a routine step in early-stage drug development. With the increasing recognition of pharmaceutical cocrystals from clinical, regulatory and legal perspectives, the systematic commercialization of cocrystal containing drug products is just a matter of time.
Pharmaceuticals as Groundwater Tracers - Applications and Limitations
Scheytt, T. J.; Mersmann, P.; Heberer, T.
2003-12-01
Pharmaceutically active substances and metabolites are found at concentrations up to the microgram/L-level in groundwater samples from the Berlin (Germany) area and from several other places world wide. Among the compounds detected in groundwater are clofibric acid, propyphenazone, diclofenac, ibuprofen, and carbamazepine. Clofibric acid, the active metabolite of clofibrate and etofibrate (blood lipid regulators) is detected in groundwater at maximum concentrations of 7300 ng/L. Among the most important input paths of drugs are excretion and disposal into the sewage system. Groundwater contamination is likely to be due to leaky sewage systems, influent streams, bank filtration, and irrigation with effluent water from sewage treatment plants. There are no known natural sources of the above mentioned pharmaceuticals. The use of pharmaceuticals as tracers may include: (a) Quantification of infiltration from underground septic tanks (b) Detection of leaky sewage systems / leaky sewage pipes (c) Estimation of the effectiveness of sewage treatment plants (d) Identification of transport pathways of other organic compounds (e) Quantification of surface water / groundwater interaction (f) Characterization of the biodegradation potential. The use of pharmaceuticals as tracers is limited by variations in input. These variations depend on the amount of drugs prescribed and used in the study area, the social structure of the community, the amount of hospital discharge, and temporal concentration variations. Furthermore, the analysis of trace amounts of pharmaceuticals is sophisticated and expensive and may therefore limit the applicability of pharmaceuticals as tracers. Finally, the transport and degradation behavior of pharmaceuticals is not fully understood. Preliminary experiments in the laboratory were conducted using sediment material and groundwater from the Berlin area to evaluate the transport and sorption behavior of selected drugs. Results of the column experiments
Using containerless methods to develop amorphous pharmaceuticals.
Weber, J K R; Benmore, C J; Suthar, K J; Tamalonis, A J; Alderman, O L G; Sendelbach, S; Kondev, V; Yarger, J; Rey, C A; Byrn, S R
2017-01-01
Many pipeline drugs have low solubility in their crystalline state and require compounding in special dosage forms to increase bioavailability for oral administration. The use of amorphous formulations increases solubility and uptake of active pharmaceutical ingredients. These forms are rapidly gaining commercial importance for both pre-clinical and clinical use. Synthesis of amorphous drugs was performed using an acoustic levitation containerless processing method and spray drying. The structure of the products was investigated using in-situ high energy X-ray diffraction. Selected solvents for processing drugs were investigated using acoustic levitation. The stability of amorphous samples was measured using X-ray diffraction. Samples processed using both spray drying and containerless synthesis were compared. We review methods for making amorphous pharmaceuticals and present data on materials made by containerless processing and spray drying. It was shown that containerless processing using acoustic levitation can be used to make phase-pure forms of drugs that are known to be difficult to amorphize. The stability and structure of the materials was investigated in the context of developing and making clinically useful formulations. Amorphous compounds are emerging as an important component of drug development and for the oral delivery of drugs with low solubility. Containerless techniques can be used to efficiently synthesize small quantities of pure amorphous forms that are potentially useful in pre-clinical trials and for use in the optimization of clinical products. Developing new pharmaceutical products is an essential enterprise to improve patient outcomes. The development and application of amorphous pharmaceuticals to increase absorption is rapidly gaining importance and it provides opportunities for breakthrough research on new drugs. There is an urgent need to solve problems associated with making formulations that are both stable and that provide high
Metabolic engineering: the ultimate paradigm for continuous pharmaceutical manufacturing.
Yadav, Vikramaditya G; Stephanopoulos, Gregory
2014-07-01
Research and development (R&D) expenditures by pharmaceutical companies doubled over the past decade, yet candidate attrition rates and development times rose markedly during this period. Understandably, companies have begun downsizing their pipelines and diverting investments away from R&D in favor of manufacturing. It is estimated that transitioning to continuous manufacturing could enable companies to compete for a share in emerging markets. Accordingly, the model for continuous manufacturing that has emerged commences with the conversion of late-stage intermediates into the active pharmaceutical ingredient (API) in a series of continuous flow reactors, followed by continuous solid processing to form finished tablets. The use of flow reactions for API synthesis will certainly generate purer products at higher yields in shorter times compared to equivalent batch reactions. However, transitioning from batch to flow configuration simply alleviates transport limitations within the reaction milieu. As the catalogue of reactions used in flow syntheses is a subset of batch-based chemistries, molecules such as natural products will continue to evade drug prospectors. Also, it is uncertain whether flow synthesis can deliver improvements in the atom and energy economies of API production at the scales that would achieve the levels of revenue growth targeted by companies. Instead, it is argued that implementing metabolic engineering for the production of oxidized scaffolds as gateway molecules for flow-based addition of electrophiles is a more effective and scalable strategy for accessing natural product chemical space. This new paradigm for manufacturing, with metabolic engineering as its engine, would also permit rapid optimization of production variables and allow facile scale-up from gram to ton scale to meet material requirements for clinical trials, thus recasting manufacturing as a tool for discovery. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
International Nuclear Information System (INIS)
1994-01-01
Many microanalytical procedure require specific natural-matrix reference materials containing very low levels of trace elements and having a high degree of homogeneity. This proposed CRP will specifically address the question of quality control materials for these techniques. The participants of the meeting discussed the requirements for certified reference materials to by used in microanalysis with particular emphasis on the homogeneity issues. This publication contains summary of the discussions along with conclusions and recommendations made by the participants. The publication also contains 13 individual presentations delivered by the participants. Each of the individual papers has been provided with an abstract and indexed separately
Energy Technology Data Exchange (ETDEWEB)
NONE
1994-07-01
Many microanalytical procedure require specific natural-matrix reference materials containing very low levels of trace elements and having a high degree of homogeneity. This proposed CRP will specifically address the question of quality control materials for these techniques. The participants of the meeting discussed the requirements for certified reference materials to by used in microanalysis with particular emphasis on the homogeneity issues. This publication contains summary of the discussions along with conclusions and recommendations made by the participants. The publication also contains 13 individual presentations delivered by the participants. Each of the individual papers has been provided with an abstract and indexed separately.
Development of Halal Pharmaceuticals Traceability Systems for Used with Mobile Devices
International Nuclear Information System (INIS)
Abd Jalil Abd Hamid
2014-01-01
From early times, the pharmaceutical industry has had simple traceability systems, but with the increasing implementation of quality management in pharmaceutical manufacture, traceability systems have become more advanced covering more information and more steps in the production chain. Pork and its byproducts are not considered permissible (non-halal) and are forbidden for muslims to consume, along with alcohol and meat from animals not slaughtered according to Islamic law. Recently, the porcine DNA crisis and debates about non-halal substances have drawn new attention to production chain traceability. Existing guidelines on halal products, especially those issued by Jakim, and the halal standard MS2424, were insufficient to overcome the heaping problems of non-halal pharmaceuticals. An effective traceability system is essential to mitigate the risks associated with non-halal pharmaceutical and also as a tool for communication making information available along the production and supply chain. Traceability in pharmaceutical manufacturing can range from in-house traceability in production plants to traceability in whole or part of the production chain from raw material to consumer, and descriptors of the product and its history can be few or many as decided. This study is written to discuss on the approaches towards development of halal pharmaceuticals traceability systems for used with mobile devices for fulfilling muslims consumer demands. Specifically, this study discusses the conceptual architecture on halal traceability system for halal pharmaceutical product in Malaysia. (author)
The A to Z of pharmaceutical cocrystals: a decade of fast-moving new science and patents.
Almarsson, Örn; Peterson, Matthew L; Zaworotko, Michael
2012-07-01
From aspirin to zoledronic acid, pharmaceutical cocrystals emerged in the past decade as a promising new weapon in the arsenal of drug development. Resurgence of interest in multicomponent crystal compositions has led to significant advances in the science of cocrystal design and discovery. These advances have built upon crystal engineering, which provides a deep understanding of supramolecular interactions between molecules that govern crystal packing and physicochemical properties of crystalline materials. Concomitantly, the patent landscape of pharmaceutical cocrystals developed rapidly in the last decade. This review presents a broad survey of patents issued in the area of pharmaceutical cocrystals. In addition, the review contains analyses of key patents in the area involving compositions and methodologies. Along the way, the main events of the past decade representing a renaissance of cocrystals of pharmaceutical materials are chronicled. Future directions in the area are discussed in light of key pending patent applications and recent publications of seminal interest.
Minimizing material damage using low temperature irradiation
Craven, E.; Hasanain, F.; Winters, M.
2012-08-01
Scientific advancements in healthcare driven both by technological breakthroughs and an aging and increasingly obese population have lead to a changing medical device market. Complex products and devices are being developed to meet the demands of leading edge medical procedures. Specialized materials in these medical devices, including pharmaceuticals and biologics as well as exotic polymers present a challenge for radiation sterilization as many of these components cannot withstand conventional irradiation methods. The irradiation of materials at dry ice temperatures has emerged as a technique that can be used to decrease the radiation sensitivity of materials. The purpose of this study is to examine the effect of low temperature irradiation on a variety of polymer materials, and over a range of temperatures from 0 °C down to -80 °C. The effectiveness of microbial kill is also investigated under each of these conditions. The results of the study show that the effect of low temperature irradiation is material dependent and can alter the balance between crosslinking and chain scission of the polymer. Low temperatures also increase the dose required to achieve an equivalent microbiological kill, therefore dose setting exercises must be performed under the environmental conditions of use.
Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda.
Paumgartten, Francisco José Roma
2016-12-22
In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.
Directory of Open Access Journals (Sweden)
M. S. Ponomarenko
2016-08-01
Full Text Available Since the beginning of creation the system of training and retraining, determining the specific role and significance of the pharmaceutical manpower from the XVI century to the present day, the discussions about their state-public organizing and permanent improvements scheme, including the system of pharmaceutical postgraduate education in accordance with the requirements of the European Union (EU are held. The purpose of the work lies in the fact that noopharmaceutical modern (non-pharmaceutical opinion and assessment of historical events, traditions, their survival, national ethical mindset in the pharmaceutical business are extrapolated for the future reform of the sector in line with EU requirements. And on the stage of review of the conceptual characteristics of primary, medium and distant prospects, the positive experience is taken into account, rejecting the already proven negative position in reforming the pharmaceutical sector in the health sector according to European modern requirements. Materials and methods. Historical literary and official sources, archival materials have been used. Modern Pharmacy memories of veterans “Figures in pharmacy” have been used. Results. Personnel policy contributes to fight against corruption and mafia in pharmacy. This way legal and regulatory policy will accelerate the destruction of pharmaceutical, pseudo productive and alcohol-drug mafia. Regulatory policy in the pharmaceutical sector will normalize events, which will provide state control quality of drugs - implementation of EU rules, attractiveness and interest of foreign manufacturers to the pharmaceutical sector of Ukraine [20-30], including the preparation of qualified pharmacists (bachelors, masters, other professionals of pharmacy and industrial pharmacy. Conclusions. The main stages of development of the property (material and human resources to provide medical treatment and patients have been detected. The basic steps of transformation
Bergström, Richard
2011-04-01
The established market model for pharmaceutical products, as for most other products, is heavily dependent on sales volumes. Thus, it is a primary interest of the producer to sell large quantities. This may be questionable for medicinal products and probably most questionable for antibacterial remedies. For these products, treatment indications are very complex and encompass both potential patient benefits, possible adverse effects in the actual patient and, which is unique for this therapeutic class, consideration about what effects the drug use will have on the future therapeutic value of the drug. This is because bacteria are sure to develop resistance. The European Federation of Pharmaceutical Industries and Associations (EFPIA) agrees with the general description of the antibacterial resistance problem and wants to participate in measures to counteract antibacterial resistance. Stakeholders should forge an alliance that will address the need for and prudent use of new antibiotics. A variety of incentives probably have to be applied, but having all in common that the financial return has to be separated from the use of the product. Copyright © 2011. Published by Elsevier Ltd.
The argument for pharmaceutical policy.
Traulsen, Janine Morgall; Almarsdóttir, Anna Birna
2005-02-01
Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.
Brixner, Diana; Kaló, Zoltán; Maniadakis, Nikos; Kim, Kyoo; Wijaya, Kalman
2018-03-29
This article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement. A literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets. An International Outcomes Research Board (IORB) of academia and industry experts conducted extensive research, meetings, and workshops to define high-priority criteria to incorporate into an evidence-based health technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA) technique. The resulting framework was further tailored for country-specific needs in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). The IORB defined nine criteria four categories (Product, Manufacturing, Service, and Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement and health policy decision making. Then the IORB developed the EFOR as a base case document, which can be adapted and used as a template by health authorities in emerging countries. Emerging countries have a significant need for an HTA tool that balances affordability with accurate evidence showing the value differentiation of OPPs. The value attributes in this setting often are different from those in developed markets, which emphasize new products and have high regulation and manufacturing standards. The EFOR is an easy-to-use, adaptable framework that emerging countries can use to increase the consistency, transparency, and effectiveness of drug decision making. The open source EFOR is available as Supplemental Materials
Directory of Open Access Journals (Sweden)
P. V. Olіynуk
2015-08-01
Full Text Available In conditions of the emergency situations’ amount increasing the readiness of the state to provide affected people and all other segments of the population with full pharmaceutical provision is important. The aim of research is an analysis of the state of the legislative and regulatory framework of governmental administration by pharmaceutical provision of the population in the conditions of emergency situations. Materials and methods. We used methods of observation and synthesis, generalization and formalization, analysis of content. The object of the study were regulations, government pharmaceutical providing of population in emergency situations. Results. Studies show the need to develop methods and principles of public administration process to ensure people with pharmaceutical and specific methodological approaches in emergency situations. Conclusions. It has been established, that it is necessary to develop scientifically based methods of governance by the process of pharmaceutical providing the affected population.
Tropical Journal of Pharmaceutical Research, June 2002; 1 (1): 63-22
African Journals Online (AJOL)
Clinical Phamacy
Development and in-vitro Evaluation of a Topical Drug ... The present study was carried out to exploit the feasibility of using polymeric ... Materials. Betamethazone. (Glaxo. SmithKline. Pharmaceuticals Ltd), Ethyl cellulose .... A dialysis tubing.
International Nuclear Information System (INIS)
2013-11-01
of materials under development for Generation IV concepts. International collaboration among MTRs and specialized facilities has been identified as integral to progress in fusion development as well as enhancing reactor utilization. This publication specifies which areas of research remain in the qualification of structural materials and components, and has detailed the characteristics of many research reactors and devices that can accomplish an important portion of these necessary studies. This publication is the outcome of two recent IAEA sponsored meetings under its programme to enhance the utilization and collaboration of research reactor and material test facilities: - Consultancy meeting on Role of Research Reactors in Materials Research for Nuclear Fusion Technology, 13-15 December 2010, IAEA, Vienna; - Technical meeting on Materials under High Energy and High Intensity Neutron Fluxes for Nuclear Fusion Technology, 27-29 June 2011, IAEA, Vienna. These meetings brought together representatives from MTRs, spallation neutron sources, multiple beam irradiation facilities, material scientists as well as fusion community representatives to discuss the current state of fusion research and to plot necessary studies and modes of research collaboration
Recent trends in the impurity profile of pharmaceuticals
Directory of Open Access Journals (Sweden)
Kavita Pilaniya
2010-01-01
Full Text Available Various regulatory authorities such as the International Conference on Harmonization (ICH, the United States Food and Drug administration (FDA, and the Canadian Drug and Health Agency (CDHA are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs. The various sources of impurity in pharmaceutical products are - reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \\ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas-liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid-liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC-Mass Spectroscopy (MS, LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.
Zhang, W.; Liu, C. H.; Bhalsod, G.; Zhang, Y.; Chuang, Y. H.; Boyd, S. A.; Teppen, B. J.; Tiedje, J. M.; Li, H.
2015-12-01
Pharmaceuticals are contaminants of emerging concern frequently detected in soil and water environments, raising serious questions on their potential impact on human and ecosystem health. Overuse and environmental release of antibiotics (i.e., a group of pharmaceuticals extensively used in human medicine and animal agriculture) pose enormous threats to the health of human, animal, and the environment, due to proliferation of antibiotic resistant bacteria. Recently, we have examined interactions of pharmaceuticals with soil geosorbents, bacteria, and vegetable crops in order to elucidate pathways of sorption, uptake, and translocation of pharmaceuticals across the multiple interfaces in soils. Sorption of pharmaceuticals by biochars was studied to assess the potential of biochar soil amendment for reducing the transport and bioavailability of antibiotics. Our preliminary results show that carbonaceous materials such as biochars and activated carbon had strong sorption capacities for antibiotics, and consequently decreased the uptake and antibiotic resistance gene expression by an Escherichia coli bioreporter. Thus, biochar soil amendment showed the potential for reducing selection pressure on antibiotic resistant bacteria. Additionally, since consumption of pharmaceutical-tainted food is a direct exposure pathway for humans, it is important to assess the uptake and accumulation of pharmaceuticals in food crops grown in contaminated soils or irrigated with reclaimed water. Therefore, we have investigated the uptake and accumulations of pharmaceuticals in greenhouse-grown lettuce under contrasting irrigation practices (i.e., overhead or surface irrigations). Preliminary results indicate that greater pharmaceutical concentrations were measured in overhead irrigated lettuce than in surface irrigated lettuce. This could have important implications when selecting irrigation scheme to use the reclaimed water for crop irrigation. In summary, proper soil and water management
[Logistics in the pharmaceutical service].
Stanko, P; Fulmeková, M
2005-11-01
The conception of the field of pharmaceutical service defines pharmaceutical service as the basic part of pharmacy, the principal task of which is to provide pharmaceutical care as an inseparable part of providing health care. It represents a set of professional activities of the pharmacist oriented to securing human and veterinary pharmaceutical products and health care products and to optimising effective, safe and quality pharmacotherapy. Technically, pharmaceutical service is an applied discipline, as it makes use of knowledge gained in other pharmaceutical, medical, psychological, social, and economic sciences. Because of its interdisciplinary character it is necessary to extend the theory of pharmaceutical service in such a way so that it may reflect all aspects of its sphere of activity. One of the possibilities is to define the pharmacy premises as an independent functional unit which operates on the basis of valid legal standards in such a way that on the one hand it secures the provision of health (pharmaceutical) care, and on the other hand it maintains its cost-effectiveness. To keep the quality of care of the patient and the economic aspect in balance, it is necessary to define the term pharmaceutical logistics also under the conditions of Slovak (Czech) pharmacy as early satisfaction of the requirements of the patient (client) in the pharmacy premises, which means that the appropriate pharmaceutical product or health care product and the appropriate information must be at the right time in the required amount and required quality in the right place.
An Overview of Pharmaceutical Validation and Process Controls in ...
African Journals Online (AJOL)
It has always been known that the processes involved in pharmaceutical production impact significantly on the quality of the products The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to ...
Radiation sterilization of pharmaceuticals and polymers
International Nuclear Information System (INIS)
Gopal, N.G.S.
1978-01-01
Radiation, in the form of high energy electrons as well as gamma radiation, has featured in the last 15 yr as a promising sterilization agent for many heat sensitive and ethylene oxide incompatible pharmaceuticals and polymers of medical usage. This article deals with (i) a comparison of the various methods of sterilization and their shortcomings, (ii) modes of interaction of radiation with matter, (iii) the types of radiation sources in common use, (iv) dosimetry, (v) dose rate effect, (vi) a literature survey of the radiation effect on pharmaceuticals in solid form as well as in aqueous solution and on polymers in the form of plastic medical products and (vii) the evaluation of the irradiated products. The effect of dose rate on the stability of these materials is emphasized. Either very little work has been done on the dose rate effect or the published information is scanty. The literature survey covers the recent period of 5 to 6 years. (author)
CATEGORY MANAGEMENT IN THE MANAGEMENT OF MINIMUM ASSORTMENT OF THE PHARMACEUTICAL ORGANIZATION
I. F. Samoshchenkova; R. Y. Garankina
2017-01-01
The main principle of the category management is the management of product category as a separate business unit. Category management directs the activities of the pharmaceutical organization to meet the consumer requirements and to provide customers with maximum benefits, which are expressed in the improved assortment,the attractive prices, the reduction of cases of lack of necessary goods, the simplifiedpurchase process. In article the structure of the category management and its role inthe ...
Introducing Pharmaceutical Care to Primary Care in Iceland—An Action Research Study
Directory of Open Access Journals (Sweden)
Anna Bryndis Blondal
2017-04-01
Full Text Available Even though pharmaceutical care is not a new concept in pharmacy, its introduction and development has proved to be challenging. In Iceland, general practitioners are not familiar with pharmaceutical care and additionally no such service is offered in pharmacies or primary care settings. Introducing pharmaceutical care in primary care in Iceland is making great efforts to follow other countries, which are bringing the pharmacist more into patient care. General practitioners are key stakeholders in this endeavor. The aim of this study was to introduce pharmacist-led pharmaceutical care into primary care clinics in Iceland in collaboration with general practitioners by presenting different setting structures. Action research provided the framework for this research. Data was collected from pharmaceutical care interventions, whereby the pharmaceutical care practitioner ensures that each of a patient’s medications is assessed to determine if it is appropriate, effective, safe, and that the patient can take medicine as expected. Sources of data included pharmaceutical care notes on patients, researcher’s notes, meetings, and interviews with general practitioners over the period of the study. The study ran from September 2013 to October 2015. Three separate semi-structured in-depth interviews were conducted with five general practitioners from one primary health care clinic in Iceland at different time points throughout the study. Pharmaceutical care was provided to elderly patients (n = 125 before and between general practitioners’ interviews. The study setting was a primary care clinic in the Reykjavik area and the patients’ homes. Results showed that the GPs’ knowledge about pharmacist competencies as healthcare providers and their potential in patient care increased. GPs would now like to have access to a pharmacist on a daily basis. Direct contact between the pharmacist and GPs is better when working in the same physical space
Pharmaceutical powder compaction technology
National Research Council Canada - National Science Library
Çelik, Metin
2011-01-01
"Revised to reflect modern pharmaceutical compacting techniques, this Second Edition guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel...
International Nuclear Information System (INIS)
Chung, Hyun-Kyung
2012-05-01
This report summarizes the proceedings of the IAEA Consultants' Meeting on 'Procedures for Evaluation of Atomic, Molecular and Plasma-Material Interaction Data for Fusion' on 7-9 February 2012. Fourteen participants from 8 Institutes of 3 Member States attended the three-day meeting held at the National Institute for Fusion Science, Toki in Japan. The report includes discussions on data evaluation activities, meeting conclusions and recommendations and the abstracts of presentations presented in the meeting. (author)
Pharmaceutical advertising in emergency departments.
Marco, Catherine A
2004-04-01
Promotion of prescription drugs represents a growing source of pharmaceutical marketing expenditures. This study was undertaken to identify the frequency of items containing pharmaceutical advertising in clinical emergency departments (EDs). In this observational study, emergency physician on-site investigators quantified a variety of items containing pharmaceutical advertising present at specified representative times and days, in clinical EDs. Measurements were obtained by 65 on-site investigators, representing 22 states. Most EDs in this study were community EDs (87% community and 14% university or university affiliate), and most were in urban settings (50% urban, 38% suburban, and 13% rural). Investigators measured 42 items per ED (mean = 42; median = 31; interquartile range of 14-55) containing pharmaceutical advertising in the clinical area. The most commonly observed items included pens (mean 15 per ED; median 10), product brochures (mean 5; median 3), stethoscope labels (mean 4; median 2), drug samples (mean 3; median 0), books (mean 3.4), mugs (mean 2.4), and published literature (mean 3.1). EDs with a policy restricting pharmaceutical representatives in the ED had significantly fewer items containing pharmaceutical advertising (median 7.5; 95% CI = 0 to 27) than EDs without such a policy (median 35; 95% CI = 27 to 47, p = 0.005, nonparametric Wilcoxon two-sample test). There were no differences in quantities of pharmaceutical advertising for EDs in community compared with university settings (p = 0.5), rural compared with urban settings (p = 0.3), or annual ED volumes (p = 0.9). Numerous items containing pharmaceutical advertising are frequently observed in EDs. Policies restricting pharmaceutical representatives in the ED are associated with reduced pharmaceutical advertising.
Billing third party payers for pharmaceutical care services.
Poirier, S; Buffington, D E; Memoli, G A
1999-01-01
To describe the steps pharmacists must complete when seeking compensation from third party payers for pharmaceutical care services. Government publications; professional publications, including manuals and newsletters; authors' personal experience. Pharmacists in increasing numbers are meeting with success in getting reimbursed by third party payers for patient care activities. However, many pharmacists remain reluctant to seek compensation because they do not understand the steps involved. Preparatory steps include obtaining a provider/supplier number, procuring appropriate claim forms, developing data collection and documentation systems, establishing professional fees, creating a marketing plan, and developing an accounting system. To bill for specific patient care services, pharmacists need to collect the patient's insurance information, obtain a statement of medical necessity from the patient's physician, complete the appropriate claim form accurately, and submit the claim with supporting documentation to the insurer. Although many claims from pharmacists are rejected initially, pharmacists who work with third party payers to understand the reasons for denial of payment often receive compensation when claims are resubmitted. Pharmacists who follow these guidelines for billing third party payers for pharmaceutical care services should notice an increase in the number of paid claims.
Impurities in Drug Products and Active Pharmaceutical Ingredients.
Kątny, M; Frankowski, M
2017-05-04
Analytical methods should be selective and fast. In modern times, scientists strive to meet the criteria of green chemistry, so they choose analytical procedures that are as short as possible and use the least toxic solvents. It is quite obvious that the products intended for human consumption should be characterized as completely as possible. The safety of a drug is dependent mainly on the impurities that it contains. High pressure liquid chromatography and ultra-high pressure liquid chromatography have been proposed as the main techniques for forced degradation and impurity profiling. The aim of this article was to characterize the relevant classification of drug impurities and to review the methods of impurities determination for atorvastatin (ATV) and duloxetine (DLX) (both in active pharmaceutical ingredients and in different dosage forms). These drugs have an impact on two systems of the human body: cardiac and nervous. Simple characteristics of ATV and DLX, their properties and specificity of action on the human body, are also included in this review. The analyzed pharmaceuticals-ATV (brand name Lipiron) and DLX (brand name Cymbalta)-were selected for this study based on annual rankings prepared by Information Medical Statistics.
Tropical Journal of Pharmaceutical Research
African Journals Online (AJOL)
Journal Homepage Image. We seek to encourage pharmaceutical and allied research of tropical and international relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and the healthcare professionals. We publish articles in pharmaceutical sciences and related ...
Manufacturing capability as a technological development indicator in the pharmaceutical industry
Directory of Open Access Journals (Sweden)
John Jairo Gallo Castro
2010-01-01
Full Text Available The pharmaceutical industrial has five subsectors: medicines, cosmetics, phytotherapeutics, cleaning products and medical devices. The medicine subsector consists of organisations producing, importing and selling these products. Most studies about this industry have been guided by economic interests without assessing technological aspects of production. This article was aimed at proposing a methodology for assessing and describing the medicine sector according to its technological development by using the manufacturing capability concept. The main information was taken from the Colombian Medicaments and Food Surveillance Institute’s (Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA databases related to pharmaceutical plant production in Bogotá, including material transformation facilities. This study led to three characteristics being identified for defining the pharmaceutical industry’s manufacturing capability: that related to the pharmacological group to which active pharmaceutical ingredients belong, that linked to specifications regarding medicines’ sterility and that related to the technology required for manufacturing each pharmaceutical product. An analysis of these features has thus been presented and some technologies have been identified which have not been transferred or assimilated by the organisations being studied. It was found that manufacturing capability should be considered as being an indicator of the degree of technological development in these subsectors in Colombia.
2010-01-01
Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally effluent had median concentrations ranging from 3.4 to >400 μg/L. Maximum concentrations of oxycodone (1700 μg/L) and metaxalone (3800 μg/L) in samples from NY3 effluent exceeded 1000 μg/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 μg/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847
[Designing the Annual Meeting and Active Learning System].
Kawamura, Kazumi
2018-01-01
At the 10th Annual Meeting of the Japanese Society for Pharmaceutical Palliative Care and Sciences our theme centered on active learning systems where adult learners engage on their own initiative. Many of the participants were pharmacists active in clinical practices. Regardless of their specialized skill-sets, pharmacists are constantly faced with difficult challenges in their daily work. Passive, one-way lectures are one resource for them, but unfortunately such lectures provide limited insights for resolving concrete problems. The present meeting aimed to show participants how to obtain information they need to solve specific real-world problems. This paper summarizes how we planned this year's meeting, including details about the debate symposium, social lunch, and online questionnaires. All these elements had the end goal of enabling learners proactivity to become their own best resource for learning. It is sincerely hoped that the design and execution of this meeting will prove resourceful for future annual meetings.
Pacilio, Julia E.; Tokarski, John T.; Quiñones, Rosalynn; Iuliucci, Robbie J.
2014-01-01
High-resolution solid-state NMR (SSNMR) spectroscopy has many advantages as a tool to characterize solid-phase material that finds applications in polymer chemistry, nanotechnology, materials science, biomolecular structure determination, and others, including the pharmaceutical industry. The technology associated with achieving high resolution…
Pharmaceutical spray drying: solid-dose process technology platform for the 21st century.
Snyder, Herman E
2012-07-01
Requirement for precise control of solid-dosage particle properties created with a scalable process technology are continuing to expand in the pharmaceutical industry. Alternate methods of drug delivery, limited active drug substance solubility and the need to improve drug product stability under room-temperature conditions are some of the pharmaceutical applications that can benefit from spray-drying technology. Used widely for decades in other industries with production rates up to several tons per hour, pharmaceutical uses for spray drying are expanding beyond excipient production and solvent removal from crystalline material. Creation of active pharmaceutical-ingredient particles with combinations of unique target properties are now more common. This review of spray-drying technology fundamentals provides a brief perspective on the internal process 'mechanics', which combine with both the liquid and solid properties of a formulation to enable high-throughput, continuous manufacturing of precision powder properties.
Pharmaceutical compounds in drinking water
Directory of Open Access Journals (Sweden)
Vikas Chander
2016-06-01
Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.
International Nuclear Information System (INIS)
1997-01-01
The international principles developed to help in the regulation and deregulation of low-activity materials require elaboration, and there is a need for guidance regarding their practical application. The objectives of the meeting, organized by the Agency were: To provide a forum in which concerns and issues concerned with the regulatory management of materials containing very low levels of radioactivity can be discussed; to develop strategies for resolving the issues through international action; to develop advice for Agency work in drafting guidance material for safety standards
Validation of the sterilization process for radiopharmaceuticals and materials with humid heat
International Nuclear Information System (INIS)
Robles, Anita; Moore, Mariel; Morote, Mario; Guevara, Buenaventura; Castro, Delcy; Paragulla, Wilson; Martinez, Ramos; Ocana, Elias; Novoa, Carlos
2014-01-01
A validation protocol has been designed and applied for the sterilization process of radiopharmaceuticals and materials, with humid heat for sodium pertechnetate Tc-99m injection solution (placebo) and materials, in compliance with good manufacturing practices for pharmaceutical products. The sterilization cycle set for each load is developed, according to the following parameters: 121 o C ± 1 o C (temperature), 15 ± 0.5 psi (pressure) and an exposure time of 20 and 15 minutes, respectively. The results in the penetration test with load, F0 values were higher than 20 minutes at 121 o C and for the biological challenge by biological indicators (Bacillus stearothermophilus) was negative in colder spots, in three consecutive runs. The sterilization process for each load and equipment has been validated to meet the established acceptance criteria. (authors).
Putcha, Lakshmi
2011-01-01
An important requirement of therapeutics for extended duration exploration missions beyond low Earth orbit will be the development of pharmaceutical technologies suitable for sustained and preventive health care in remote and adverse environmental conditions. Availability of sustained, stable and targeted delivery pharmaceuticals for preventive health of major organ systems including gastrointestinal, hepato-renal, musculo-skeletal and immune function are essential to offset adverse effects of space environment beyond low Earth orbit. Specifically, medical needs may include multi-drug combinations for hormone replacement, radiation protection, immune enhancement and organ function restoration. Additionally, extended stability of pharmaceuticals dispensed in space must be also considered in future drug development. Emerging technologies that can deliver stable and multi-therapy pharmaceutical preparations and delivery systems include nanotechnology based drug delivery platforms, targeted-delivery systems in non-oral and non-parenteral formulation matrices. Synthetic nanomaterials designed with molecular precision offer defined structures, electronics, and chemistries to be efficient drug carriers with clear advantages over conventional materials of drug delivery matricies. Nano-carrier materials like the bottle brush polymers may be suitable for systemic delivery of drug cocktails while Superparamagnetic Iron Oxide Nanoparticles or (SPIONS) have great potential to serve as carriers for targeted drug delivery to a specific site. These and other emerging concepts of drug delivery and extended shelf-life technologies will be reviewed in light of their application to address health-care challenges of exploration missions. Innovations in alternate treatments for sustained immune enhancement and infection control will be also discussed.
Penicillin dust exposure and penicillin resistance among pharmaceutical workers in Tehran, Iran.
Farshad, Ali Asghar; Enferadi, Mojtaba; Bakand, Shahnaz; Jamshidi Orak, Rouhangiz; Mirkazemi, Roksana
2016-07-01
Antimicrobial resistance (AMR) adversely impacts the prevention and treatment of a wide range of infections and is considered as a serious threat to global public health. Occupational-related AMR is a neglected area of research. To assess exposure to penicillin dust, penicillin active materials, and to report the frequency of penicillin resistance among pharmaceutical workers in Tehran, Iran. A quasi-experimental study was conducted among workers on a penicillin production line in a pharmaceutical company (n = 60) and workers in a food producing company (n = 60). Data were collected via survey, air sampling, and throat swab. The mean overall concentrations of penicillin dust and penicillin active material were 6.6 and 4.3 mg/m 3 , respectively, in the pharmaceutical industry. Streptococcus pneumoniae (S. pneumoniae) was detected in 45% (27) individuals in the exposed group, 92.6% of which showed penicillin resistance. Resistance was significantly higher among workers in penicillin production line (p = 0.014). High level of AMR among workers in penicillin production line is a health risk for the workers as well as society as a whole through the spread of drug resistant micro-organisms.
International Nuclear Information System (INIS)
Watson, R.D.
1986-09-01
This paper contains a collection of viewgraphs from a joint meeting of the Division of Development and Technology Plasma/Materials Interaction and High Heat Flux Materials and Components Task Groups. A list of contributing topics is: PPPL update, ATF update, Los Alamos RFP program update, status of DIII-D, PMI graphite studies at ORNL, PMI studies for low atomic number materials, high heat flux materials issues, high heat flux testing program, particle confinement in tokamaks, helium self pumping, self-regenerating coatings technical planning activity and international collaboration update
Polymers for Pharmaceutical Packaging and Delivery Systems
DEFF Research Database (Denmark)
Fristrup, Charlotte Juel
materials of interest for pharmaceutical packaging and delivery systems. Confocal fluorescence microscopy studies and stability studies with insulin aspart (AspB28 insulin) were conducted to evaluate the impact of modified PP compared to unmodified PP. In contrast to PEEK, PP did not contain any functional....... In order to decrease the amount of catalyst residual in the modified materials, activator regenerated by electron transfer (ARGET) SI-ATRP was applied in the second experimental round. Two poly(ethylene glycol)methyl ether methacrylate (MPEGMA) monomers with 4 and 23 ethylene oxide units in the side chain......Selection of polymer materials which will be exposed to protein drugs in either containers or medical devices is often very challenging due to the demands on the polymers. Suitable polymer materials should comply with requirements like compatibility with proteins, sterilisability, good barrier...
Malviya, Rishabha; Sharma, Pramod Kumar; Dubey, Susheel Kumar
2016-11-01
Polymer modifications open new era for the development of polymers with requisite properties. Use of modified polymers is practically boundless. Different studies focus on biomedical applications of chemically modified polysaccharides. Development and utilization of modified polysaccharides get attention to be used as carrier for pharmaceutical drug delivery as well as tissue engineering scaffolds. Grafted polymer shows better cellular regeneration, signal transmission, diagnostic and imaging material than putative form. This review article aims to discuss various approaches to modify naturally derived polymer and their applications as pharmaceutical drug carrier and as a material for wound dressing and artificial cartilage due to better biophysical cues. Manuscript included various patents based on the applications of modified polymers and techniques used to modify polymers. Copyright © 2016 Elsevier B.V. All rights reserved.
Wei, Guoguang; Mangal, Sharad; Denman, John; Gengenbach, Thomas; Lee Bonar, Kevin; Khan, Rubayat I; Qu, Li; Li, Tonglei; Zhou, Qi Tony
2017-10-01
This study has investigated the surface coating efficiency and powder flow improvement of a model cohesive acetaminophen powder by high-shear processing with pharmaceutical lubricants through 2 common equipment, conical comil and high-shear mixer. Effects of coating materials and processing parameters on powder flow and surface coating coverage were evaluated. Both Carr's index and shear cell data indicated that processing with the lubricants using comil or high-shear mixer substantially improved the flow of the cohesive acetaminophen powder. Flow improvement was most pronounced for those processed with 1% wt/wt magnesium stearate, from "cohesive" for the V-blended sample to "easy flowing" for the optimally coated sample. Qualitative and quantitative characterizations demonstrated a greater degree of surface coverage for high-shear mixing compared with comilling; nevertheless, flow properties of the samples at the corresponding optimized conditions were comparable between 2 techniques. Scanning electron microscopy images demonstrated different coating mechanisms with magnesium stearate or l-leucine (magnesium stearate forms a coating layer and leucine coating increases surface roughness). Furthermore, surface coating with hydrophobic magnesium stearate did not retard the dissolution kinetics of acetaminophen. Future studies are warranted to evaluate tableting behavior of such dry-coated pharmaceutical powders. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Remedial action programs annual meeting: Meeting notes
International Nuclear Information System (INIS)
1987-01-01
The US Department of Energy Grand Junction Projects Office was pleased to host the 1987 Remedial Action programs Annual Meeting and herein presents notes from that meeting as prepared (on relatively short notice) by participants. These notes are a summary of the information derived from the workshops, case studies, and ad hoc committee reports rather than formal proceedings. The order of the materials in this report follows the actual sequence of presentations during the annual meeting
IAEA technical meeting on fissile material strategies for sustainable nuclear energy
International Nuclear Information System (INIS)
Ganguly, Chaitanyamoy; Koyama, Kazutoshi
2005-01-01
A Technical Meeting (TM) on 'Fissile Material Management Strategies for Sustainable Nuclear Energy' was organized by the International Atomic Energy Agency (IAEA) in Vienna from 12 to 15 September 2005. Prior to the TM, three Working Groups (WG) composed of experts from 10 countries prepared Key Issues papers on: 1) Uranium Demand and Supply through 2050; 2) Back-end Fuel Cycle Options; and 3) Sustainable Nuclear Energy beyond 2050: Cross-cutting Issues. Some 36 papers, including 3 key issue papers, were presented during the TM in 3 different sessions. The present paper summarizes the deliberations of the TM. (author)
Pacheco, Daniela P; Reis, Rui L; Correlo, Vítor M; Marques, Alexandra P
2015-01-01
Tissue-engineered constructs made of biotechnology-derived materials have been preferred due to their chemical and physical composition, which offers both high versatility and a support to enclose/ incorporate relevant signaling molecules and/or genes known to therapeutically induce tissue repair. Herein, a critical overview of the impact of different biotechnology-derived materials, scaffolds, and recombinant signaling molecules over the behavior of cells, another element of tissue engineered constructs, as well its regulatory role in tissue regeneration and disease progression is given. Additionally, these tissue-engineered constructs evolved to three-dimensional (3D) tissue-like models that, as an advancement of two-dimensional standard culture methods, are expected to be a valuable tool in the field of drug discovery and pharmaceutical research. Despite the improved design and conception of current proposed 3D tissue-like models, advanced control systems to enable and accelerate streamlining and automation of the numerous labor-intensive steps intrinsic to the development of tissue-engineered constructs are still to be achieved. In this sense, this review intends to present the biotechnology- derived materials that are being explored in the field of tissue engineering to generate 3D tissue-analogues and briefly highlight their foremost breakthroughs in tissue regeneration and drug discovery. It also aims to reinforce that the crosstalk between tissue engineering and pharmaceutical biotechnology has been fostering the outcomes of tissue engineering approaches through the use of biotechnology-derived signaling molecules. Gene delivery/therapy is also discussed as a forefront area that represents another cross point between tissue engineering and pharmaceutical biotechnology, in which nucleic acids can be considered a "super pharmaceutical" to drive biological responses, including tissue regeneration.
Wu-Pong, Susanna; Gobburu, Jogarao; O'Barr, Stephen; Shah, Kumar; Huber, Jason; Weiner, Daniel
2013-05-13
Despite pharma's recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences graduate programs are currently maintaining traditional methods for master's and doctoral student education. The literature on graduate education in the biomedical sciences has long been advocating educating students to hone soft skills like communication and teamwork, in addition to maintaining excellent basic skills in research. However, recommendations to date have not taken into account the future trends in the pharmaceutical industry. The AACP Graduate Education Special Interest Group has completed a literature survey of the trends in the pharmaceutical industry and graduate education in order to determine whether our graduate programs are strategically positioned to prepare our graduates for successful careers in the next few decades. We recommend that our pharmaceutical sciences graduate programs take a proactive leadership role in meeting the needs of our future graduates and employers. Our graduate programs should bring to education the innovation and collaboration that our industry also requires to be successful and relevant in this century.
[Hospital pharmaceutical practice in prison].
Harcouët, L
2010-09-01
Since 1994, hospital pharmaceutical teams have been in charge of pharmaceutical tasks in "unités de consultation et de soins ambulatoires" (UCSA), which are hospital consulting care units in French prisons. In 2008, pharmaceutical team in Parisian prisons received 6500 prescriptions and prepared 85,000 nominative bags containing drugs. Prisoners were 1.3% to receive treatments against HIV, 8.2% cardiovascular drugs, 7.2% opioid substitution treatments, and 52.9% psychoactive drugs, including 39.3% hypnotics, 40.5% anxiolytics, 11.3% antidepressants and 12.2% neuroleptics. In prison, the dichotomy between somatic and mental care is marked, attitudes of prisoners about their medicines are complex (important claims, embezzlement, etc.) and it is difficult for law defendants to maintain treatment confidentiality and to prepare prison outing in terms of health. To attenuate the heterogeneity of drug distribution systems in French prisons, we propose pharmaceutical analysis of prescriptions and nominative dispensation, computerization in UCSA in coordination with hospitals, a better contribution of prison medical and pharmaceutical staff in hospital "drug committees" and the redaction of pharmaceutical guidelines. Acting in concert with multidisciplinary medical staff in UCSA, pharmaceutical teams have to develop epidemiological studies to improve knowledge in prisoner's health and also prevention and health care in prison. Copyright © 2010 Elsevier Masson SAS. All rights reserved.
Radiation sterilization of some pharmaceutical preparations and medical products
International Nuclear Information System (INIS)
Tashmetov, M.Yu.; Makhkamov, Sh.M.; Urinov, Sh.S.; Turaev, A.S.; Sultanov, M.S.; Inagomov, Kh.S.
2006-01-01
sterilization; a low power spectrum of radiation (1.25 MeV); radiating activity is completely excluded; low temperature at radiating processing; medical properties, quality and functional purpose of a preparation and a product are kept. Mechanical and structural infringements of processed production are excluded, high accuracy of the control of a phase of irradiation, adaptability to manufacture and profitability of the method of processing are provided. By present time the technology of radiation sterilization of many kinds of pharmaceutical preparations and medical products is developed, however the sterilizing doze for each material - product in various different countries. It is connected with quality of materials and components from which pharmaceutical preparations and medical products are prepared, technologies of their manufacture, packing materials, and climatic conditions in each country. Experimental works on development of technology of sterilization of pharmaceutical preparations and medical products is carried out in the two research channels gamma facility of the INP AS RU, designed for radiating processing of various products, substances and production. As experimental objects for radiation sterilization: injection syringes for unitary application; surgical threads (catgut); hygienic packages, tampons, surgical cotton wool; the medical product 'Glipil' are chosen. Various dose and temperature regimes for sterilization of single use syringes, made in Uzbekistan are studied, and certain optimal doze of sterilization is reached providing the highest degree of sterility, as well as functionalities and initial optical parameters. By the radiating of surgical threads (catgut, silk) in two gamma channels with various capacities at temperatures up to 25 deg C a certain optimal doze of sterilization with preservation of their initial durability qualities was determined. Medical product 'Glipil' which demanding the special conditions of sterilization, connected not only
Pharmaceutical cocrystals: an overview.
Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary
2011-10-31
Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper. Copyright © 2011 Elsevier B.V. All rights reserved.
International Nuclear Information System (INIS)
2011-05-01
Research reactors (RRs) have played, and continue to play, a key role in the development of the peaceful uses of nuclear energy and technology. The role of the IAEA is to assist Member States in the effective utilization of these technologies in various domains of research such as fundamental and applied science, industry, human health care and environmental studies, as well as nuclear energy applications. In particular, material testing reactors (MTRs), serve as unique tools in scientific and technological development and they have quite a wide variety of applications. Today, a large range of different RR designs exist when compared with power reactors and they also have different operating modes, producing high neutron fluxes, which may be steady or pulsed. Recently, an urgent need has arisen for the development of new advanced materials, for example in the nuclear industry, where RRs offer capacities for irradiation programmes. Besides the scientific and research activities and commercial applications, RRs are also used extensively for educational training activities for scientists and engineers. This report is a compilation of outputs of an IAEA Technical Meeting (TM-34779) held on Research Reactor Application for Materials under High Neutron Fluence. The overall objective of the meeting was to review typical applications of small and medium size RRs, such as material characterization and testing, neutron physics and beam research, neutron radiography and imaging as well as isotope production and other types of non-nuclear applications. Several issues were discussed during the meeting, in particular: (1) recent development of irradiation facilities, specific irradiation programmes and their implementation; (2) effective and optimal RR operation regimes for irradiation purposes; (3) sharing of best practices and existing technical knowledge; and (4) fostering of advanced or innovative technologies, e.g. information exchange and effective collaboration. This
Sirés, Ignasi; Brillas, Enric
2012-04-01
In the last years, the decontamination and disinfection of waters by means of direct or integrated electrochemical processes are being considered as a very appealing alternative due to the significant improvement of the electrode materials and the coupling with low-cost renewable energy sources. Many electrochemical technologies are currently available for the remediation of waters contaminated by refractory organic pollutants such as pharmaceutical micropollutants, whose presence in the environment has become a matter of major concern. Recent reviews have focused on the removal of pharmaceutical residues upon the application of other important methods like ozonation and advanced oxidation processes. Here, we present an overview on the electrochemical methods devised for the treatment of pharmaceutical residues from both, synthetic solutions and real pharmaceutical wastewaters. Electrochemical separation technologies such as membrane technologies, electrocoagulation and internal micro-electrolysis, which only isolate the pollutants from water, are firstly introduced. The fundamentals and experimental set-ups involved in technologies that allow the degradation of pharmaceuticals, like anodic oxidation, electro-oxidation with active chlorine, electro-Fenton, photoelectro-Fenton and photoelectrocatalysis among others, are further discussed. Progress on the promising solar photoelectro-Fenton process devised and further developed in our laboratory is especially highlighted and documented. The abatement of total organic carbon or reduction of chemical oxygen demand from contaminated waters allows the comparison between the different methods and materials. The routes for the degradation of the some pharmaceuticals are also presented. Copyright © 2011 Elsevier Ltd. All rights reserved.
Pharmaceutical applications of magnetic resonance imaging (MRI).
Richardson, J Craig; Bowtell, Richard W; Mäder, Karsten; Melia, Colin D
2005-06-15
Magnetic resonance imaging (MRI) is a powerful imaging modality that provides internal images of materials and living organisms on a microscopic and macroscopic scale. It is non-invasive and non-destructive, and one of very few techniques that can observe internal events inside undisturbed specimens in situ. It is versatile, as a wide range of NMR modalities can be accessed, and 2D and 3D imaging can be undertaken. Despite widespread use and major advances in clinical MRI, it has seen limited application in the pharmaceutical sciences. In vitro studies have focussed on drug release mechanisms in polymeric delivery systems, but isolated studies of bioadhesion, tablet properties, and extrusion and mixing processes illustrate the wider potential. Perhaps the greatest potential however, lies in investigations of pharmaceuticals in vivo, where pilot human and animal studies have demonstrated we can obtain unique insights into the behaviour of gastrointestinal, topical, colloidal, and targeted drug delivery systems.
Sex, gender, and pharmaceutical politics: From drug development to marketing.
Fisher, Jill A; Ronald, Lorna M
2010-08-01
Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing. This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials. The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals. The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome. Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and
International Nuclear Information System (INIS)
2002-01-01
Many microanalytical procedure require specific natural-matrix reference materials containing very low levels of trace elements and having a high degree of homogeneity. This proposed CRP will specifically address the question of quality control materials for these techniques. The participants of the meeting discussed the requirements for certified reference materials to by used in microanalysis with particular emphasis on the homogeneity issues. This publication contains summary of the discussions along with conclusions and recommendations made by the participants. The publication also contains ten individual presentations delivered by the participants. Each of the individual papers has been provided with an abstract and indexed separately
Helmlinger, Gabriel; Al-Huniti, Nidal; Aksenov, Sergey; Peskov, Kirill; Hallow, Karen M; Chu, Lulu; Boulton, David; Eriksson, Ulf; Hamrén, Bengt; Lambert, Craig; Masson, Eric; Tomkinson, Helen; Stanski, Donald
2017-11-15
Modeling & simulation (M&S) methodologies are established quantitative tools, which have proven to be useful in supporting the research, development (R&D), regulatory approval, and marketing of novel therapeutics. Applications of M&S help design efficient studies and interpret their results in context of all available data and knowledge to enable effective decision-making during the R&D process. In this mini-review, we focus on two sets of modeling approaches: population-based models, which are well-established within the pharmaceutical industry today, and fall under the discipline of clinical pharmacometrics (PMX); and systems dynamics models, which encompass a range of models of (patho-)physiology amenable to pharmacological intervention, of signaling pathways in biology, and of substance distribution in the body (today known as physiologically-based pharmacokinetic models) - which today may be collectively referred to as quantitative systems pharmacology models (QSP). We next describe the convergence - or rather selected integration - of PMX and QSP approaches into 'middle-out' drug-disease models, which retain selected mechanistic aspects, while remaining parsimonious, fit-for-purpose, and able to address variability and the testing of covariates. We further propose development opportunities for drug-disease systems models, to increase their utility and applicability throughout the preclinical and clinical spectrum of pharmaceutical R&D. Copyright © 2017 Elsevier B.V. All rights reserved.
Energy Technology Data Exchange (ETDEWEB)
Malviya, Rishabha, E-mail: rishabhamalviya19@gmail.com [Polymer Science Laboratory, Department of Pharmacy, School of Medical & Allied Sciences, Galgotias University, Greator Noida, UP (India); Department of Pharmacy, Uttarkhand Technical University, Dehradun, Uttarkhand (India); Sharma, Pramod Kumar [Polymer Science Laboratory, Department of Pharmacy, School of Medical & Allied Sciences, Galgotias University, Greator Noida, UP (India); Dubey, Susheel Kumar [Siddarth Institute of Pharmacy, Dehradun, Uttarkhand (India)
2016-11-01
Polymer modifications open new era for the development of polymers with requisite properties. Use of modified polymers is practically boundless. Different studies focus on biomedical applications of chemically modified polysaccharides. Development and utilization of modified polysaccharides get attention to be used as carrier for pharmaceutical drug delivery as well as tissue engineering scaffolds. Grafted polymer shows better cellular regeneration, signal transmission, diagnostic and imaging material than putative form. This review article aims to discuss various approaches to modify naturally derived polymer and their applications as pharmaceutical drug carrier and as a material for wound dressing and artificial cartilage due to better biophysical cues. Manuscript included various patents based on the applications of modified polymers and techniques used to modify polymers. - Highlights: • Properties of natural polysaccharides can be modulated by modification in their basic backbone. • Polysaccharides can be easily modified using microwave irradiation as compared to conventional closed vessel modification. • Biodegradable and biocompatible nature of modified polymer promotes their use in targeted cellular delivery of pharmaceuticals. • Studies show strong support that biodegradable polymers have ability to modulate cell signaling, cellular attachment, migration, proliferation and differentiation. • Manuscript reveals the fact that various commercial patents have been granted for the use of modified polymer.
An experimental investigation of temperature rise during compaction of pharmaceutical powders.
Krok, Alexander; Mirtic, Andreja; Reynolds, Gavin K; Schiano, Serena; Roberts, Ron; Wu, Chuan-Yu
2016-11-20
During pharmaceutical powder compaction, temperature rise in the compressed powder can affect physiochemical properties of the powder, such as thermal degradation and change in crystallinity. Thus, it is of practical importance to understand the effect of process conditions and material properties on the thermal response of pharmaceutical formulations during compaction. The aim of this study was to examine the temperature rise of pharmaceutical powders during tableting, in particular, to explore how the temperature rise depends on material properties, compression speed and tablet shape. Three grades of microcrystalline cellulose (MCC) were considered: MCC Avicel pH 101, MCC Avicel pH 102 and MCC DG. These powders were compressed using a compaction simulator at various compaction speeds (10-500mm/s). Flat faced, shallow convex and normal convex tablets were produced and temperature distributions on the surface of theses tablets upon ejection were examined using an infrared thermoviewer. It was found that an increase in the compaction speed led to an increase in the average surface temperature. A higher surface temperature was induced when the powder was compressed into a tablet with larger surface curvature. This was primarily due to the increasing degree of powder deformation (i.e. the volume reduction) and the effect of interparticule/wall friction. Copyright © 2016 Elsevier B.V. All rights reserved.
Growth of the Asian health-care market: global implications for the pharmaceutical industry.
Epstein, Richard J
2007-10-01
The global economy is being transformed by an explosion of information unleashed by the internet, the digital revolution, communications and increased international mobility. This transformation is manifesting in many ways, including rapid development of countries such as China, commoditization of public services, mobilization of workforces, shifting of market control from suppliers to consumers, interlinked rises in product demand and customer expectations, and problems regulating international business competition. As Asia is home to half of the world's population, and offers both a large relatively low-cost workforce in some countries and a potentially huge retail market, this region could be central to the future of the global economy. Like other industries, the pharmaceutical industry faces a new array of Asia-specific opportunities and challenges. Success in meeting these challenges will go to those pharmaceutical companies that best understand the unique strengths and constraints of Asia's diverse cultures, talents and markets.
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth report.
2016-01-01
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.
Analysis of Pharmaceutical Excipient MCC Avicel PH102 Using Compaction Equations
Directory of Open Access Journals (Sweden)
Peciar Peter
2016-07-01
Full Text Available This paper focuses on the characterization of the tabletting process and analysis one of the most common pharmaceutical excipients MCC Avicel PH102 by Heckel, Kawakita, Cooper-Eaton and Adams compaction equations. Experimental material was determined by measuring its parameters as particle size distribution, angle of wall friction and flow properties and for more detailed characteristics of the material particles, microscopy images of the powder before and after compressing were created.
Electrochemical biosensors in pharmaceutical analysis
Gil, Eric de Souza; Melo, Giselle Rodrigues de
2010-01-01
Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, fo...
Pharmaceutical and biomedical applications of lipid-based nanocarriers.
Carbone, Claudia; Leonardi, Antonio; Cupri, Sarha; Puglisi, Giovanni; Pignatello, Rosario
2014-03-01
Increasing attention is being given to lipid nanocarriers (LNs) as drug delivery systems, due to the advantages offered of a higher biocompatibility and lower toxicity compared with polymeric nanoparticles. Many administration routes are being investigated for LNs, including topical, oral and parenteral ones. LNs are also proposed for specific applications such as cancer treatment, gene therapy, diagnosis and medical devices production. However, the high number of published research articles does not match an equal amount of patents. A recent Review of ours, published in Pharmaceutical Patent Analyst, reported the patents proposing novel methods for the production of LNs. This review work discusses recent patents, filed in 2007-2013 and dealing with the industrial applications of lipid-based nanocarriers for the vectorization of therapeutically relevant molecules, as well as biotech products such as proteins, gene material and vaccines, in the pharmaceutical, diagnostic and biomedical areas.
International Nuclear Information System (INIS)
Langley, R.A.
1995-12-01
The proceedings and results of the Final IAEA Research Coordination Meeting on ''Plasma-interaction Induced Erosion of Fusion Reactor Materials'' held on October 9, 10 and 11, 1995 at the IAEA Headquarters in Vienna are briefly described. This report includes a summary of presentations made by the meeting participants, the results of a data survey and needs assessment for the erosion of plasma facing components and in-vessel materials, and recommendations regarding future work. (author). Refs, figs, tabs
Pattern of pharmaceutical retailing of anti-diabetic products in Ibadan, Nigeria.
Famuyiwa, O O
1991-01-01
Twenty-four pharmacists in the city of Ibadan were surveyed through a self-administered structured questionnaire as to the extent of their involvement in the pharmaceutical retailing of antidiabetic products and their cost. Oral hypoglycemic agents especially, chlorpropamide (Diabenese) and glibenclamide (Daonil) were the most readily available drugs being obtainable from 21 (87.5%) pharmacies. Insulin was stocked regularly by only 14 (58.3%) of the pharmacists and insulin syringes and needles could be obtained from only 10 (41.6%) of the pharmacies. Among materials for urine testing, clinistix strip was the most readily available and fully one-third of the pharmacies did not stock any such material. The prices of all the products were disturbingly high and between 1983 and 1986 when retail prices were re-assessed, the cost of some materials had escalated by as much as 400%. Scarcity of antidiabetic products and their high cost pose serious challenges for those involved in the care of diabetic patients in Nigeria. Some suggestions have been made as to what steps both the government and the pharmaceutical industry can take in ensuring the availability of these life sustaining products for the increasingly large Nigerian diabetic population.
Jihan M Badr
2013-01-01
Background: Yohimbine is an indole alkaloid used as a promising therapy for erectile dysfunction. A number of methods were reported for the analysis of yohimbine in the bark or in pharmaceutical preparations. Materials and Method: In the present work, a simple and sensitive high performance thin layer chromatographic method is developed for determination of yohimbine (occurring as yohimbine hydrochloride) in pharmaceutical preparations and validated according to International Conference of Ha...
International Nuclear Information System (INIS)
Nygren, R.E.
1992-04-01
The Plasma/Wall Interaction and High Heat Flux Materials and Components Task Groups typically hold a joint meeting each year to provide a forum for discussion of technical issues of current interest as well as an opportunity for program reviews by the Department of Energy (DOE). At the meeting in September 1990, reported here, research programs in support of the International Thermonuclear Experimental Reactor (ITER) were highlighted. The first part of the meeting was devoted to research and development (R ampersand D) for ITER on plasma facing components plus introductory presentations on some current projects and design studies. The balance of the meeting was devoted to program reviews, which included presentations by most of the participants in the Small Business Innovative Research (SBIR) Programs with activities related to plasma wall interactions. The Task Groups on Plasma/Wall Interaction and on High Heat Flux Materials and Components were chartered as continuing working groups by the Division of Development and Technology in DOE's Magnetic Fusion Program. This report is an addition to the series of ''blue cover'' reports on the Joint Meetings of the Plasma/Wall Interaction and High Heat Flux Materials and Components Task Groups. Among several preceding meetings were those in October 1989 and January 1988
What residents don't know about physician-pharmaceutical industry interactions.
Watkins, Raquel S; Kimberly, James
2004-05-01
Little is known about the knowledge and skills internal medicine residents need to interact appropriately with pharmaceutical industry representatives. The authors conducted a needs assessment of current knowledge and preferences for potential components of a new educational initiative among residents. In 2001, a two-page questionnaire using a five-point ordinal scale was mailed to all internal medicine residents and faculty at one institution. Analysis included use of Wilcoxon two-sample test. Response rates were 97% (85/88) for residents and 79% (86/109) for faculty. Residents and faculty's knowledge about formal position statements or literature on the impact of marketing strategies on prescribing patterns, drug marketing costs, or how pharmaceutical representatives are trained to interact with physicians was very limited. Most responders felt residents should learn to critically interpret promotional materials, recognize potential for conflict of interest, and consider how patients perceive the physician-pharmaceutical industry relationship. More faculty than residents valued including position statements (66% versus 39%, p marketing on prescribing patterns (70% versus 41%, p education. Only one-half or fewer favored small-group discussions, lecture series, critical-reading skills seminars, or panel discussions. Internal medicine residents and faculty reported low levels of knowledge about physician-pharmaceutical industry relationships. Some consensus about educational components existed, but optimal educational formats remain uncertain. A six-hour curriculum to address this complex, emotionally charged topic was developed, implemented, and evaluated.
Energy Technology Data Exchange (ETDEWEB)
Fitzsimmons, Tim [Dept. of Energy (DOE), Washington DC (United States). Office of Basic Energy Sciences. Division of Materials Sciences and Engineering
2006-05-16
This volume highlights the scientific content of the 2006 Hydrogen Contractors Meeting sponsored by the Division of Materials Sciences and Engineering (DMS&E) on behalf of the Office of Basic Energy Sciences (BES) of the U. S. Department of Energy (DOE). Hydrogen Contractors Meeting held from May 16-19, 2006 at the Crystal Gateway Marriott Hotel Arlington, Virginia. This meeting is the second in a series of research theme-based Contractors Meetings sponsored by DMS&E held in conjunction with our counterparts in the Office of Energy Efficiency and Renewable Energy (EERE) and the first with the Hydrogen, Fuel Cells and Infrastructure Technologies Program. The focus of this year’s meeting is BES funded fundamental research underpinning advancement of hydrogen storage. The major goals of these research efforts are the development of a fundamental scientific base in terms of new concepts, theories and computational tools; new characterization capabilities; and new materials that could be used or mimicked in advancing capabilities for hydrogen storage.
Directory of Open Access Journals (Sweden)
Ershova Elena Vladimirovna
2015-10-01
Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.
PREFACE: Brazil MRS Meeting 2014
2015-11-01
The annual meetings, organized by the Brazilian materials research society - B-MRS, are amongst the most import discussion forums in the area of materials science and engineering in Brazil, with a growing interest from the national and international scientific society. In the last 4 years, more than 1,500 participants have attended the B-MRS meetings, promoting an auspicious environment for presentation and discussion of scientific and technological works in the materials science area. The XIII Brazilian Materials Research Society Meeting was held from 28 September to 02 October, 2014, in João Pessoa, PB, Brazil. The Meeting congregated more than 1650 participants from the whole of Brazil and from 28 other countries. More than 2100 abstracts were accepted for presentation, distributed along 19 Symposia following the format used in traditional meetings of Materials Research Societies. These involved topics such as: synthesis of new materials, computer simulations, optical, magnetic and electronic properties, traditional materials as clays and cements, advanced metals, carbon and graphene nanostructures, nanomaterials for nanostructures, energy storage systems, composites, surface engineering and others. A novelty was a symposium dedicated to innovation and technology transfer in materials research. The program also included 7 Plenary Lectures presented by internationally renowned researchers: Alberto Salleo from Stanford University, United States of America; Roberto Dovesi from Universita' degli Studi di Torino, Italy; Luís Antonio F. M. Dias Carlos from Universidade de Aveiro, Portugal; Jean Marie Dubois from Institut Jean-Lamour, France; Sir Colin Humphreys from University of Cambridge, England; Karl Leo from Technische Universität Dresden, Germany; Robert Chang from Northwestern University, Evanston, United States of America. The numbers of participants in the B-MRS meetings have been growing continuously, and in this meeting we had almost 2200 presentations
Pharmaceuticals labelled with stable isotopes
International Nuclear Information System (INIS)
Krumbiegel, P.
1986-11-01
The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13 C, 15 N, and 2 H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2 H, 13 C, and 15 N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)
Bruyere, O; Kanis, J A; Ibar-Abadie, M-E; Alsayed, N; Brandi, M L; Burlet, N; Cahall, D L; Chines, A; Devogelaer, J-P; Dere, W; Goel, N; Hughes, N; Kaufman, J-M; Korte, S; Mitlak, B H; Niese, D; Rizzoli, R; Rovati, L C; Reginster, J-Y
2010-05-01
This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. Real or perceived problems in the relationship between academics and the industry have been the subject of much recent debate. It has been suggested that academic clinicians should sever all links with the industry-a view that is rarely challenged. Academic experts and members of the pharmaceutical industry were invited to an expert consensus meeting to debate this topic. This meeting was organized by the Group for the Respect of Ethics and Excellence in Science. Conflict of interest, competing interest, right and duties of academic scientist, authorship, and staff and student education were discussed. Guidelines for a transparent, ethical, strong, and successful partnership between the academic scientist and the pharmaceutical industry have been provided. The Group support interactions between the industry and clinicians provided that it is transparent and ethical.
Directory of Open Access Journals (Sweden)
Sonali S. Bharate
2010-09-01
Full Text Available Studies of active drug/excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. The potential physical and chemical interactions between drugs and excipients can affect the chemical nature, the stability and bioavailability of drugs and, consequently, their therapeutic efficacy and safety. The present review covers the literature reports of interaction and incompatibilities of commonly used pharmaceutical excipients with different active pharmaceutical ingredients in solid dosage forms. Examples of active drug/excipient interactions, such as transacylation, the Maillard browning reaction, acid base reactions and physical changes are discussed for different active pharmaceutical ingredients belonging to different therapeutic categories viz antiviral, anti-inflammatory, antidiabetic, antihypertensive, anti-convulsant, antibiotic, bronchodialator, antimalarial, antiemetic, antiamoebic, antipsychotic, antidepressant, anticancer, anticoagulant and sedative/hypnotic drugs and vitamins. Once the solid-state reactions of a pharmaceutical system are understood, the necessary steps can be taken to avoid reactivity and improve the stability of drug substances and products.
International Nuclear Information System (INIS)
2013-12-01
For many years, the increase in efficiency in the production of nuclear electricity has been an economic challenge in many countries which have developed this kind of energy. The increase in fuel burnup and fuel residence time leads to a reduction in the volume of fresh fuel loaded and spent fuel discharged, respectively. More demanding nuclear fuel cycle parameters are combined with a need to operate nuclear power plants with maximal availability and load factors, in load-follow mode and with longer fuel cycles. In meeting these requirements, fuel has to operate in a demanding environment of high radiation fields, high temperatures, high mechanical stresses and high coolant flow. Requirements of increased fuel reliability and minimal fuel failures also remain in force. Under such circumstances, continuous development of more radiation resistant fuel materials, especially advanced cladding, careful and incremental examinations, and improved understanding and modelling of high burnup fuel behaviour are required. Following a recommendation of the IAEA Technical Working Group on Fuel Performance and Technology, the Technical Meeting on In-pile Testing and Instrumentation for Development of Generation-IV Fuels and Materials was held in Halden, Norway, on 21-24 August 2012. The purpose of the meeting was to review the current status and the progress in methods and technologies used for the in-pile testing of nuclear fuel achieved since the previous IAEA meeting on In-core Instrumentation and Reactor Core Assessment, also held in Halden in 2007. Emphasis was placed on advanced techniques applied for the understanding of high burnup fuel behaviour of water cooled power reactors that represent the vast majority of the current nuclear reactor fleet. However, the meeting also included papers and discussion on testing techniques applied or developed specifically for new fuel and structural materials considered for Generation-IV systems. The meeting was attended by 43
Preference for pharmaceutical formulation and treatment process attributes
Directory of Open Access Journals (Sweden)
Stewart KD
2016-07-01
, acute vs chronic and patient (eg, injection experience characteristics.Conclusion: Despite heterogeneity in study methods and design, some general patterns of preference clearly emerged. Overall, the results of this review suggest that treatment process has a quantifiable impact on preference and willingness to pay for treatment, even in many situations where safety and efficacy were the primary concerns. Patient preferences for treatment process attributes can inform drug development decisions to better meet the needs of patients and deliver improved outcomes. Keywords: preference, treatment process, pharmaceutical formulation, conjoint, utility, contingent valuation
[PICS: pharmaceutical inspection cooperation scheme].
Morénas, J
2009-01-01
The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.
Recognizing misleading pharmaceutical marketing online.
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
2014-01-01
In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.
Directory of Open Access Journals (Sweden)
N. O. Tkachenko
2017-12-01
Full Text Available The modern development of the social policy of pharmaceutical organizations in Ukraine, focused on the needs of society, is characterized by the lag in practical implementation of appropriate social responsibility (SR from the increased interest of pharmaceutical scientists in its various aspects. Issues of personal identity, its role and place in the system of socially responsible behavior of pharmaceutical organizations and the professional activity of pharmacists remain insufficiently studied. The purpose research. Conceptual analysis of the social responsibility of the individual with the integration into pharmacy and the rationale for strategic directions for the formation of social responsibility as a professional competence of pharmacists in the system of continuous pharmaceutical education. Materials and methods. We used the methods of information retrieval, comparison, systematization, analysis, synthesis and modeling. Materials for research were publications of fundamental and applied research of domestic and foreign scientists on issues of social responsibility, international standards. Results. Personality in the process of activity is both the subject and the object of responsibility, since social responsibility is a condition for interaction between the individual and the society. The social responsibility of pharmacy specialists directed to primary and secondary social groups, society and the individual, as well as to oneself. In the latter case, the self-concept is important, that is, the individual's complete self-image and the readiness of the individual to act in a certain way in certain situations, as well as the possible social roles of the pharmacist. The process of forming the social responsibility of pharmacy specialists is a complex level system that continuously educates, develops and improves the skill of social responsibility throughout professional life. Conclusions. On the basis of theoretical generalization of the
International Nuclear Information System (INIS)
2009-01-01
The key topics of the meeting are the following: Radiation damage phenomena and modelling of material properties under irradiation; On-going challenges in radiation materials science; Key material parameters and operational conditions of selected reactor designs; Microstructures and mechanical properties of nuclear structural materials; Pathways to development of new structural materials; Qualification of new structural materials; Advanced microstructure probing methods; Special emphasis is given to the application of nuclear techniques in the development and qualification of new structural materials.
International Nuclear Information System (INIS)
1997-01-01
The aim of the Technical Committee Meeting (TCM) was to review developed systems and methods in diagnostics in the scope of their impacts and importance to the safety of Nuclear Power Plants. Papers presented on TCM came from different sources, from developers, from manufacturers, from licensing authorities and from NPP personal. They reflect up to date status in the given subject. Participants of TCM formulated three working groups to elaborate different questions which were raised during the discussions. Their results are reflected in the three chapter titles of the given material. Annex 1 to this document contains presentations made at the Technical Committee Meeting. Refs, figs, tabs
1984-04-01
No.356 MATERIALS SUBSTITUTION AND RECYCLING Papers presented at the 5 7th Meeting of the Structures and Materials Panel in Vimneiro, Portupi. 19 -14...nation. The mission of AGARD is carried out through the Panels which are composed of experts appointed by the National Delegates, the Consultant and...composition. The quality heat treatment for monocrystalline alloys such as CMSX2 normally consists of a 3-stage process, viz., Stage 1 2-3 hours @ 1260°C
Pharmaceutical care in Kuwait: hospital pharmacists' perspectives.
Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B
2014-12-01
Pharmaceutical care practice has been championed as the primary mission of the pharmacy profession, but its implementation has been suboptimal in many developing countries including Kuwait. Pharmacists must have sufficient knowledge, skills, and positive attitudes to practise pharmaceutical care, and barriers in the pharmacy practice model must be overcome before pharmaceutical care can be broadly implemented in a given healthcare system. To investigate hospital pharmacists' attitudes towards pharmaceutical care, perceptions of their preparedness to provide pharmaceutical care, and the barriers to its implementation in Kuwait. Six general hospitals, eight specialized hospitals and seven specialized health centers in Kuwait. A descriptive, cross-sectional survey was distributed to all pharmacists working in the governmental hospitals in Kuwait (385 pharmacists). Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (standard deviations) were calculated and compared using statistical package for social sciences, version 20. Statistical significance was accepted at a p value of Kuwait. Completed surveys were received from 250 (64.9%) of the 385 pharmacists. Pharmacists expressed overall positive attitudes towards pharmaceutical care. They felt well prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Pharmacists with more practice experience expressed significantly more positive attitudes towards pharmaceutical care (p = 0.001) and they felt better prepared to provide pharmaceutical care competencies (p Kuwait advocate implementation of pharmaceutical care while also appreciating the organizational, technical and professional barriers to its widespread adoption. Collaborative efforts between health authorities and educational institutions, and the integration of innovative approaches in
Berry, David J; Steed, Jonathan W
2017-08-01
As small molecule drugs become harder to develop and less cost effective for patient use, efficient strategies for their property improvement become increasingly important to global health initiatives. Improvements in the physical properties of Active Pharmaceutical Ingredients (APIs), without changes in the covalent chemistry, have long been possible through the application of binary component solids. This was first achieved through the use of pharmaceutical salts, within the last 10-15years with cocrystals and more recently coamorphous systems have also been consciously applied to this problem. In order to rationally discover the best multicomponent phase for drug development, intermolecular interactions need to be considered at all stages of the process. This review highlights the current thinking in this area and the state of the art in: pharmaceutical multicomponent phase design, the intermolecular interactions in these phases, the implications of these interactions on the material properties and the pharmacokinetics in a patient. Copyright © 2017 Elsevier B.V. All rights reserved.
The role of cocrystals in pharmaceutical science.
Shan, Ning; Zaworotko, Michael J
2008-05-01
Pharmaceutical cocrystals, a subset of a long known but little-studied class of compounds, represent an emerging class of crystal forms in the context of pharmaceutical science. They are attractive to pharmaceutical scientists because they can significantly diversify the number of crystal forms that exist for a particular active pharmaceutical ingredient (API), and they can lead to improvements in physical properties of clinical relevance. In this article we address pharmaceutical cocrystals from the perspective of design (crystal engineering) and present a series of case studies that demonstrate how they can enhance the solubility, bioavailability, and/or stability of API crystal forms.
Fast-Scan DSC and its role in pharmaceutical physical form characterisation and selection.
Ford, James L; Mann, Timothy E
2012-04-01
Conventional rate Differential Scanning Calorimetry (DSC) has been used for many years as a tool in the analysis of pharmaceutical materials. In recent years an extension of the technique to include fast heating and cooling rates has become more prevalent. Broadly termed Fast-Scan DSC, this review examines the current applications of this technique to the characterisation and selection of pharmaceutical materials. Its increasing use encompasses the characterisation of amorphousness in crystalline materials, the characterisation of polymorphs and polymorphic transitions, the solubility of drugs in polymers, and characterisation of dosage forms. Notwithstanding the advantages of analytical speed in analytical turnover, the review emphasises the advantages of Fast-Scan DSC in its sensitivity which allows the separation of overlapping thermal events, the reduction it provides in degradation during the scanning process and its role in determining solubility in waxy and polymeric based systems. A comparison of the uses of Fast-Scan DSC to modulated DSC techniques and localised thermal analysis is also given. © 2011 Elsevier B.V. All rights reserved.
International Nuclear Information System (INIS)
Abdul Jalil Abd Hamid; Shafii Khamis; Rehir Dahalan
2011-01-01
Paper batch records have been used for decades to record procedures, the types and quantities of each material used, and the status of each step in the manufacturing process for both pharmaceuticals and medical devices. Although paper batch records are well established in its implementation, the system is laborious to maintain and prone to human error, particularly as manufacturing operations become increasingly complicated. Many pharmaceutical manufacturers are currently evaluating the feasibility of Electronic Batch Record (EBR) system. An integrated EBR system has been developed by Medical Technology Division of Nuclear Malaysia to monitor process and equipment used in the manufacture of pharmaceuticals and medical devices. The system architecture consists of an iPAN7 data processing system operating under Microsoft Windows Embedded CE 6.0 R2. The system serves as a common data bank and an input/output device for the iPAN7 processors. Full traceability from component material to finished product is maintained. Properly implemented, EBR eliminate paperwork, speed up information distribution, and provide useful tools for improving quality and efficiency. This paper discusses the general system requirements and specifications along with the hardware and software required to implement those requirements and specifications. Also discussed are problems which were encountered after initial development and plans for future development, and a plan for extending and commercializing this technology. (author)
Entrepreneurial patent management in pharmaceutical startups.
Holgersson, Marcus; Phan, Tai; Hedner, Thomas
2016-07-01
Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.
Introduction: Institutional corruption and the pharmaceutical policy.
Rodwin, Marc A
2013-01-01
Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. © 2013 American Society of Law, Medicine & Ethics, Inc.
Balcom, Ian N.; Driscoll, Heather; Vincent, James; Leduc, Meagan
2016-01-01
Pharmaceuticals and other micropollutants have been detected in drinking water, groundwater, surface water, and soil around the world. Even in locations where wastewater treatment is required, they can be found in drinking water wells, municipal water supplies, and agricultural soils. It is clear conventional wastewater treatment technologies are not meeting the challenge of the mounting pressures on global freshwater supplies. Cost-effective ecological wastewater treatment technologies have ...
Integrating systems Approaches into Pharmaceutical Sciences
DEFF Research Database (Denmark)
Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.
2008-01-01
During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...
Materials modified by irradiation
International Nuclear Information System (INIS)
Chmielewski, A.G.
2007-01-01
Application of radiation in pharmaceutical sciences and cosmetology, polymer materials, food industry, environment, health camre products and packing production is described. Nano-technology is described more detailed, because it is less known as irradiation using technology. Economic influence of the irradiation on the materials value addition is shown
The Effectiveness of Pharmaceutical Marketing
E.R. Kappe
2011-01-01
textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to
International Nuclear Information System (INIS)
1996-01-01
The objectives of the Technical Committee Meeting was to review the activities of research on radioactive materials release and sodium fires in fast reactors in each of the participating countries. It covered: out-of-pile experiments and analysis codes on source term; in-pile experiments on source term; core disruptive accidents; sodium leak experience in liquid metal fast reactors; evaluation of sodium fire; and aerosol behaviour
Energy Technology Data Exchange (ETDEWEB)
NONE
1996-07-01
The objectives of the Technical Committee Meeting was to review the activities of research on radioactive materials release and sodium fires in fast reactors in each of the participating countries. It covered: out-of-pile experiments and analysis codes on source term; in-pile experiments on source term; core disruptive accidents; sodium leak experience in liquid metal fast reactors; evaluation of sodium fire; and aerosol behaviour.
Directory of Open Access Journals (Sweden)
M. M. Bahlol
2016-01-01
Full Text Available Purpose. Pharmaceutical industry is transnational and globally important. Many pharmaceutical companies operate their business in multinational and international forms in different countries. Diverse researches from different countries indicated and confirmed marketing promotion importance in pharmaceutical field. Therefore, marketing promotion and its effects are a very important issue that should be globally investigated in real life and evidence context. We oriented our research according to these scientific and practical values.Methodology. We reviewed pharmaceutical marketing promotion researches from more than 25 different countries, e.g., USA, Canada, Italy, France, Russia, India, Egypt and Syria where we employed our knowledge of three widely spread languages, i.e., English, Russian and Arabic. Such language variation supports us with large and variable amount of scientific knowledge, deep understanding and ability of analysis. Some studies investigated average response to pharmaceutical marketing promotion and few studies took into consideration heterogeneity in their effects with respect to advertising medium or drug characteristics.Originality. We investigated empirical evidences of pharmaceutical marketing promotion that can be directed to either consumer or healthcare professionals.Findings. We extracted, gathered and associated information of pharmaceutical promotion globally which oriented us to several evidence and practical facts with regard to employing promotion tools in different definite situations pertinent to main directions; their welfare and health enhancing effects and adverse effects. Practical Implications- Consequently, we developed practically-oriented guidelines for companies concerning pharmaceutical promotion globally ate the end of this paper.
[Bioequivalence studies of pharmaceutical preparations].
Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H
2007-01-01
Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.
Institute of Nuclear Materials Management 36. annual meeting: Proceedings. Volume 24
International Nuclear Information System (INIS)
Anon.
1995-01-01
The sessions at this meeting covered the following topics: international safeguards; physical protection; material control and accountability (MC and A) training; waste overview; nonproliferation and arms control -- US/former Soviet Union; MC and A/physical protection -- SNM storage; spent fuel storage; physical protection -- intrusion sensors and access delay; MC and A -- gamma ray and holdup measurements; MC and A -- neutron based measurements; MC and A/nonproliferation and arms control -- fissile materials disposition; low level waste; packaging and transportation; international safeguards and nonproliferation and arms control -- IAEA verification in the US; international safeguards and physical protection -- video systems; poster and demonstrations; international safeguards and physical protection -- T.I.D.'s, tags and seals; high level wastes and mixed waste; MC and A -- bulk measurements; MC and A and physical protection -- policy; nonproliferation and arms control -- detection and monitoring techniques; nonproliferation and arms control -- US-Russian lab-to-lab safeguards cooperation; MC and A -- information systems; physical protection and MC and A -- vulnerability assessments; waste management -- measurement; international safeguards -- integrated and remote monitoring systems; MC and A -- material control and accountability and indicators; nonproliferation and arms control -- treaties and analysis; nonproliferation and arms control -- plutonium/HEU nonproliferation; MC and A -- measurement control and verification; and international safeguards and nonproliferation and arms control -- environmental monitoring and export control. Separate abstracts were prepared for some of the papers in this volume
Marketing orientation in pharmaceutical industry
Directory of Open Access Journals (Sweden)
Prošić Danica
2006-01-01
Full Text Available Pharmaceutical companies are major stakeholders in the global health agenda Virtually all drugs used by patients in Europe reach markets through the promotion tactics of a small number of corporations with a tremendous impact on global health. The sector is both fast growing and highly profitable. Effective marketing strategies are a crucial ingredient in making sure pharmaceutical products and profits flow in a virtuous cycle. At first glance, the relationship between doctors and drug companies, as well as advertising practices for over-the-counter medication, appears tightly regulated. According to many consumer organizations, drug promotion in Europe today can be characterized as nice and friendly marketing. This refers to the creation of a false sense of trust that consumers associate with branded pharmaceutical products, as a result of pharmaceutical marketing efforts disguised as genuine corporate responsibility.
PARTICULARITIES OF MODERN PHARMACEUTICAL PROMOTION
Directory of Open Access Journals (Sweden)
Юрий Владимирович Тарасов
2014-02-01
Full Text Available Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1
National transparency assessment of Kuwait's pharmaceutical sector.
Badawi, Dalia A; Alkhamis, Yousif; Qaddoumi, Mohammad; Behbehani, Kazem
2015-09-01
Corruption is one of several factors that may hinder the access to pharmaceuticals. Since Kuwait has the highest per-capita spending on pharmaceuticals in the region, we wanted to evaluate the level of transparency in its pharmaceutical sector using an established assessment tool adapted by the World Health Organization. Standardized questionnaires were conducted via semi-structured interviews with key informants to measure the level of transparency in eight functions of the public pharmaceutical sector. The scores for the degree of vulnerability to corruption reflected marginal to moderate venerability to corruption for most pharmaceutical sectors. The perceived strengths included availability of appropriate laws, the presence of clear standard operating procedures, and the use of an efficient registration/distribution system. Weaknesses included lack of conflict of interest guidelines and written terms of reference, absence of pharmacoeconomic studies, and inconsistencies in law enforcement. Findings reveal that few functions of Kuwait pharmaceutical sector remain fairly vulnerable to corruption. However, the willingness of Kuwait Ministry of Health to adopt the assessment study and the acknowledgement of the weaknesses of current processes of the pharmaceutical sector may assist to achieve a transparent pharmaceutical system in the near future. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Strategic Management of Innovations at Pharmaceutical Enterprises
Directory of Open Access Journals (Sweden)
Honcharova Svіtlana Yu.
2014-01-01
Full Text Available The article is devoted to theoretical and practical issues of the use of the concept of strategic management of innovations at pharmaceutical enterprises. It studies main barriers, which restrict development of Ukrainian pharmaceutical enterprises. It analyses the state and tendencies of development of innovation activity of pharmaceutical enterprises and studies foreign experience of innovation activity. It marks out specific features of strategic management of innovation development in pharmaceutical industry. It specifies the role and advantages of methods of strategic analysis in the system of management of a pharmaceutical enterprise. It considers the essence of “innovation development” and “innovation model of development” notions and analyses their organisational and legal provision. It justifies strategic tasks of the pharmaceutical filed to focus on in order to achieve a breakthrough when building an innovation model of economic development. The article proves that the most important factors that ensure growth of efficiency of pharmaceutical production are: wide application of the concept of strategic management and creation of innovations.
Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li
2016-01-01
A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.
Controlling in situ crystallization of pharmaceutical particles within the spray dryer.
Woo, Meng Wai; Lee, May Ginn; Shakiba, Soroush; Mansouri, Shahnaz
2017-11-01
Simultaneous solidification and in situ crystallization (or partial crystallization) of droplets within the drying chamber are commonly encountered in the spray drying of pharmaceuticals. The crystallinity developed will determine the functionality of the powder and its stability during storage. This review discusses strategies that can be used to control the in situ crystallization process. Areas covered: The premise of the strategies discussed focuses on the manipulation of the droplet drying rate relative to the timescale of crystallization. This can be undertaken by the control of the spray drying operation, by the use of volatile materials and by the inclusion of additives. Several predictive approaches for in situ crystallization control and new spray dryer configuration strategies are further discussed. Expert opinion: Most reports, hitherto, have focused on the crystallinity of the spray dried material or the development of crystallinity during storage. More mechanistic understanding of the in situ crystallization process during spray drying is required to guide product formulation trials. The key challenge will be in adapting the mechanistic approach to the myriad possible formulations in the pharmaceutical industry.
Rheology in Pharmaceutical Sciences
DEFF Research Database (Denmark)
Aho, Johanna; Hvidt, Søren; Baldursdottir, Stefania
2016-01-01
Rheology is the science of flow and deformation of matter. Particularly gels and non-Newtonian fluids, which exhibit complex flow behavior, are frequently encountered in pharmaceutical engineering and manufacturing, or when dealing with various in vivo fluids. Therefore understanding rheology......, together with the common measurement techniques and their practical applications. Examples of the use of rheological techniques in the pharmaceutical field, as well as other closely related fields such as food and polymer science, are also given....... is important, and the ability to use rheological characterization tools is of great importance for any pharmaceutical scientist involved in the field. Flow can be generated by shear or extensional deformations, or a combination of both. This chapter introduces the basics of both shear and extensional rheology...
Pharmaceutical Public-Private Partnerships
DEFF Research Database (Denmark)
Bagley, Constance; Tvarnø, Christina D.
2014-01-01
This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding...... and a practical perspective on how properly crafted PPPP arrangements can promote innovation more efficiently than traditional self-optimizing contracts. In particular, a properly framed binding contract, coupled with respect for positive incentives, can move the parties away from an inefficient prisoners...... systems to build and share innovation. When coupled with appropriate attention to the difficult task of coordinating the actions of interdependent actors, a PPPP arrangement can enhance the likelihood of successful commercialization of pharmacological discoveries by flipping the par- ties’ incentives...
Emerging applications of radiation processing. Proceedings of a technical meeting
Energy Technology Data Exchange (ETDEWEB)
NONE
2004-01-01
Approximately 160 gamma irradiators and 1200 electron accelerator based processing units are in operation worldwide. In recent years the IAEA has prepared a directory of industrial gamma irradiators and held several meetings on developments in radiation technology applications. Developments involving the engineering of new sources (both isotope and electrical), high power accelerator applications, etc. have been reported recently, making a review and evaluation of this progress timely. Therefore the IAEA organized a technical meeting in Vienna, Austria, from 28 to 30 April 2003 to review the present situation and the potential contribution of radiation technology to sustainable development. Engineering developments and other features of radiation sources, both isotope and accelerator, were discussed. Recent research has concentrated on three fields: medical and food products, polymers, and environmental pollution control. The stability of radiation sterilized medical implants, as well as the uses of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials, radiation synthesis and modification of polymers for biomedical applications have been studied. Since separation and enrichment technologies play an important role in product recovery and pollution control, the possibility of radiation synthesis of stimuli-responsive membranes, hydrogels and adsorbents is being investigated. Finally, aside from the technologies for flue gas and wastewater treatment already in use, further research is ongoing on the treatment of organic contaminants in both gaseous and liquid phases. Environmental applications, which also offer new opportunities, should be carefully reviewed to reflect existing regulations and current knowledge. The increasingly serious problem of polyaromatic hydrocarbons (PAH) emissions may be solved in part by the application of radiation technology. This is being studied on a pilot scale for the removal of
Emerging applications of radiation processing. Proceedings of a technical meeting
International Nuclear Information System (INIS)
2004-01-01
Approximately 160 gamma irradiators and 1200 electron accelerator based processing units are in operation worldwide. In recent years the IAEA has prepared a directory of industrial gamma irradiators and held several meetings on developments in radiation technology applications. Developments involving the engineering of new sources (both isotope and electrical), high power accelerator applications, etc. have been reported recently, making a review and evaluation of this progress timely. Therefore the IAEA organized a technical meeting in Vienna, Austria, from 28 to 30 April 2003 to review the present situation and the potential contribution of radiation technology to sustainable development. Engineering developments and other features of radiation sources, both isotope and accelerator, were discussed. Recent research has concentrated on three fields: medical and food products, polymers, and environmental pollution control. The stability of radiation sterilized medical implants, as well as the uses of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials, radiation synthesis and modification of polymers for biomedical applications have been studied. Since separation and enrichment technologies play an important role in product recovery and pollution control, the possibility of radiation synthesis of stimuli-responsive membranes, hydrogels and adsorbents is being investigated. Finally, aside from the technologies for flue gas and wastewater treatment already in use, further research is ongoing on the treatment of organic contaminants in both gaseous and liquid phases. Environmental applications, which also offer new opportunities, should be carefully reviewed to reflect existing regulations and current knowledge. The increasingly serious problem of polyaromatic hydrocarbons (PAH) emissions may be solved in part by the application of radiation technology. This is being studied on a pilot scale for the removal of
International Nuclear Information System (INIS)
1996-01-01
The purpose of this meeting was to provide an international forum for presentation and discussion of experiences in the design and operation of training centres for nuclear power plant personnel. The term ''training centre'', as used during this meeting, includes both those facilities that are dedicated to provide training for an individual nuclear power plants, and that are often located near that plant, as well as facilities that provide training for multiple NPPs, and which are operated by vendors or by utility organizations that are not directly controlled by the NPP organizations which they serve. The topic, ''design of training centres'' was used in its broadest sense to include not only facilities (such as classrooms, laboratories and simulators), but also design of: training organizations; training programmes and materials; and examination/evaluation methods. Refs, figs, tabs
Energy Technology Data Exchange (ETDEWEB)
NONE
1996-11-01
The purpose of this meeting was to provide an international forum for presentation and discussion of experiences in the design and operation of training centres for nuclear power plant personnel. The term ``training centre``, as used during this meeting, includes both those facilities that are dedicated to provide training for an individual nuclear power plants, and that are often located near that plant, as well as facilities that provide training for multiple NPPs, and which are operated by vendors or by utility organizations that are not directly controlled by the NPP organizations which they serve. The topic, ``design of training centres`` was used in its broadest sense to include not only facilities (such as classrooms, laboratories and simulators), but also design of: training organizations; training programmes and materials; and examination/evaluation methods. Refs, figs, tabs.
Structural-functional and parametric analysis of the social function of pharmaceutical industry
Directory of Open Access Journals (Sweden)
N. O. Tkachenko
2016-12-01
Full Text Available Pharmacy has always had a special (social value and was sensitive to the new social changes in the society and the state. These changes allow better understand the issues associated with increasing the efficiency of pharmaceutical care to the population. The aim of the work: identify, justify and to summarize the main elements of the social function of pharmacy, as a component of health care system, to further evaluate the properties of the pharmaceutical industry as a system. Materials and methods. To achieve this goal the principle of a systematic approach and the complex of research methods such as structural, functional and parametric analysis, logical knowledge and comparison, ad also generalization have been used. As materials of research, we used the results of fundamental and applied research of national and foreign experts on the issue. Results and discussion. The basic principles of the welfare state and pharmacy as socially oriented sectors of the economy have been determined. We have found that the pharmaceutical industry is an agent, which implements a number of elements of the social function, such as pharmaceutical assistance to the population, the production of social goods (drugs, medical products, medical cosmetics, etc., creating and providing of working places, paying taxes (replenishment of the state budget, the formation and development of human capital, research and innovation activities, charity and sponsorship, environmental protection. Ukraine formally acceded to United Nations document, «Agenda for the XXI Century». This agreement commits our government to implement development and implementation of sustainable development strategies. Its main components are the social responsibility, social integration, an efficient worker and effective owner. Social responsibility acts as a reverse reaction on realization of social policy through the main sectors of the economy. Conclusions. We have summarized the information and
Conceptualizing Pharmaceutical Plants
DEFF Research Database (Denmark)
Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel
2006-01-01
In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....
Proceedings of the 10. Brazilian meeting on magnetic resonance. Abstracts and program
International Nuclear Information System (INIS)
2008-01-01
This annual meeting, held in Brazil from August 4 - 8, 2008 comprised: one mini-course about the use of nuclear magnetic resonance for structural chemical analyses); four major conferences ('NMR applied to molecular dynamics studies of solids and semi-solids', 'Beyond genomes: assessing protein function using solution NMR', 'NMR applied to natural products', 'Solid-state NMR as a tool for the investigation of membrane-associated peptides and proteins'), four short conferences ('NMR applied to petroleum, derivatives and biofuels', 'NMR of solids applied to pharmaceutical drugs', 'NMR applied to agricultural and cattle raising quality control', 'NMR applied to oil wells logging'); oral presentations of three undergrad, three M.Sc., and three Ph.D. projects; nine other research works presented as oral communications and fifty two as congress panels/posters), most being carried out by scientific groups from various Brazilian R and D institutions. Prizes to nine remarkable works of undergrad and post-grad students have been awarded, and a General Assembly meeting of AUREMN, the Brazilian Association of Nuclear Magnetic Resonance Users, also took place at the end of the event. Main topics of the research works presented at this meeting, both as oral communications and as congress panels, were thus distributed: 24% in chemical sciences (mainly organic chemistry), 45% in applied life sciences (agricultural and food sciences, biological sciences and medicine), 29% in materials science (including petroleum and alternative fuels), and 2% regarding development of equipment accessories and improvement of instrumental techniques
PSE in Pharmaceutical Process Development
DEFF Research Database (Denmark)
Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John
2011-01-01
The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper will discuss the use of Process Systems Engineering (PSE) methods in pharmaceutical process development, and searches for answers to questions such as: Which PSE...
Santos, Lúcia H M L M; Gros, Meritxell; Rodriguez-Mozaz, Sara; Delerue-Matos, Cristina; Pena, Angelina; Barceló, Damià; Montenegro, M Conceição B S M
2013-09-01
The impact of effluent wastewaters from four different hospitals: a university (1456 beds), a general (350 beds), a pediatric (110 beds) and a maternity hospital (96 beds), which are conveyed to the same wastewater treatment plant (WWTP), was evaluated in the receiving urban wastewaters. The occurrence of 78 pharmaceuticals belonging to several therapeutic classes was assessed in hospital effluents and WWTP wastewaters (influent and effluent) as well as the contribution of each hospital in WWTP influent in terms of pharmaceutical load. Results indicate that pharmaceuticals are widespread pollutants in both hospital and urban wastewaters. The contribution of hospitals to the input of pharmaceuticals in urban wastewaters widely varies, according to their dimension. The estimated total mass loadings were 306 g d(-1) for the university hospital, 155 g d(-1) for the general one, 14 g d(-1) for the pediatric hospital and 1.5 g d(-1) for the maternity hospital, showing that the biggest hospitals have a greater contribution to the total mass load of pharmaceuticals. Furthermore, analysis of individual contributions of each therapeutic group showed that NSAIDs, analgesics and antibiotics are among the groups with the highest inputs. Removal efficiency can go from over 90% for pharmaceuticals like acetaminophen and ibuprofen to not removal for β-blockers and salbutamol. Total mass load of pharmaceuticals into receiving surface waters was estimated between 5 and 14 g/d/1000 inhabitants. Finally, the environmental risk posed by pharmaceuticals detected in hospital and WWTP effluents was assessed by means of hazard quotients toward different trophic levels (algae, daphnids and fish). Several pharmaceuticals present in the different matrices were identified as potentially hazardous to aquatic organisms, showing that especial attention should be paid to antibiotics such as ciprofloxacin, ofloxacin, sulfamethoxazole, azithromycin and clarithromycin, since their hazard quotients
Novel methodology for pharmaceutical expenditure forecast
Vataire, Anne-Lise; Cetinsoy, Laurent; Aball?a, Samuel; R?muzat, C?cile; Urbinati, Duccio; Kornfeld, ?sa; Mzoughi, Olfa; Toumi, Mondher
2014-01-01
Background and objective: The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the ‘EU Pharmaceutical e...
Bioremediation Kinetics of Pharmaceutical Industrial Effluent
M. Šabić; M. Vuković Domanovac; Z. Findrik Blažević; E. Meštrović
2015-01-01
In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmente...
Schiffelers, M.J.W.A.; Blaauboer, B.J.; Bakker, W.E.; Beken, S.; Hendriksen, C.F.M.; Koeter, H.; Krul, C.A.M.
2014-01-01
Pharmaceuticals and chemicals are subjected to regulatory safety testing accounting for approximately 25% of laboratory animal use in Europe. This testing meets various objections and has led to the development of a range of 3R models to Replace, Reduce or Refine the animal models. However, these
International Nuclear Information System (INIS)
Braams, B.J.
2013-04-01
Nine experts in the field of plasma-wall interaction on beryllium surfaces together with IAEA staff met at IAEA Headquarters 26-28 September 2012 for the First Research Coordination Meeting of an IAEA Coordinated Research Project on data for erosion and tritium retention in beryllium plasma-facing materials. They described their on-going research, reviewed the main data needs and made plans for coordinated research during the remaining years of the project. The proceedings of the meeting are summarized in this report. (author)
Vulnerabilities to misinformation in online pharmaceutical marketing.
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
2013-05-01
Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.
Pharmaceutical policies in European countries.
Barros, Pedro Pita
2010-01-01
Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).
78 FR 67201 - Sunshine Act Meeting
2013-11-08
... Institutional Advancement Committee will meet telephonically on November 22, 2013. The meeting will commence at... of the closed session meeting of the Institutional Advancement Committee. The transcript of any... 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in...
International Nuclear Information System (INIS)
1995-09-01
The stable isotope composition of elements varies in natural compounds as a consequence of the slightly different physico-chemical behaviour of isotopes. The possibility of measuring the stable isotope relative variations with high precision, using mass spectrometry, promoted the rise of new fields of research in geochemistry and hydrology and, more recently, in environmental studies. The steady growth of these investigations and of their practical applications has emphasized the need for high quality isotopic standards and intercomparison samples, with well determined isotopic composition, for the intercalibration of analytical techniques and results among laboratories. The organization of the Consultants Meeting on Stable Isotope Standards and Intercomparison Materials held in Vienna from 1 to 3 December 1993, the fifth of this type (the previous meetings took place in 1966, 1976, 1983 and 1985), called for a review and a discussion of the characteristics, quality and availability of the existing standards and intercalibration materials, and for an assessment of needs for new materials, in view of recent developments and applications. A large part of the discussions was devoted to the new materials prepared for sulphur isotope analysis and the analytical requirements for highly precise isotopic analysis of CO 2 . The papers presented at the meeting are assembled in this volume. Refs, figs and tabs
Energy Technology Data Exchange (ETDEWEB)
NONE
1995-09-01
The stable isotope composition of elements varies in natural compounds as a consequence of the slightly different physico-chemical behaviour of isotopes. The possibility of measuring the stable isotope relative variations with high precision, using mass spectrometry, promoted the rise of new fields of research in geochemistry and hydrology and, more recently, in environmental studies. The steady growth of these investigations and of their practical applications has emphasized the need for high quality isotopic standards and intercomparison samples, with well determined isotopic composition, for the intercalibration of analytical techniques and results among laboratories. The organization of the Consultants Meeting on Stable Isotope Standards and Intercomparison Materials held in Vienna from 1 to 3 December 1993, the fifth of this type (the previous meetings took place in 1966, 1976, 1983 and 1985), called for a review and a discussion of the characteristics, quality and availability of the existing standards and intercalibration materials, and for an assessment of needs for new materials, in view of recent developments and applications. A large part of the discussions was devoted to the new materials prepared for sulphur isotope analysis and the analytical requirements for highly precise isotopic analysis of CO{sub 2}. The papers presented at the meeting are assembled in this volume. Refs, figs and tabs.
International Nuclear Information System (INIS)
Chung, Hyun-Kyung
2012-12-01
This report summarizes the proceedings of the Joint IAEA-NFRI Technical Meeting on 'Data Evaluation for Atomic, Molecular and Plasma Material Interaction Processes in Fusion' on 4-7 September 2012. Twenty five participants from 10 Member States and two from the IAEA attended the four-day meeting held at the Daejeon Convention Center in Daejeon, Republic of Korea hosted by the National Fusion Research Institute (NFRI) in conjunction with the 8th International Symposium on Standard Reference Data. The report includes discussions on the issues of the critical assessment of fundamental data required for fusion and plasma applications, meeting conclusions and recommendations. The abstracts of presentations presented in the meeting are attached in the Appendix. (author)
Nanocrystals Technology for Pharmaceutical Science.
Cheng, Zhongyao; Lian, Yumei; Kamal, Zul; Ma, Xin; Chen, Jianjun; Zhou, Xinbo; Su, Jing; Qiu, Mingfeng
2018-05-17
Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described. Secondly, the application of nanocrystals technology in pharmaceutical science is mainly discussed followed by the introduction of sustained release formulations. Then, the scaling up process, marketed nanocrystal drug products and regulatory aspects about nanodrugs are summarized. Finally, the specific challenges and opportunities of nanocrystals technology for pharmaceutical science are summarized and discussed. This review will provide a comprehensive guide for scientists and engineers in the field of pharmaceutical science and biochemical engineering. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.
EU pharmaceutical expenditure forecast
Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher
2014-01-01
Background and Objectives: With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ ph...
Nanotechnology tools in pharmaceutical R&D
Challa S.S.R. Kumar
2010-01-01
Nanotechnology is a new approach to problem solving and can be considered as a collection of tools and ideas which can be applied in pharmaceutical industry. Application of nanotechnology tools in pharmaceutical R&D is likely to result in moving the industry from ‘blockbuster drug’ model to ‘personalized medicine’. There are compelling applications in pharmaceutical industry where inexpensive nanotechnology tools can be utilized. The review explores the possibility of categorizing various nan...
The evolution of hot-stage microscopy to aid solid-state characterizations of pharmaceutical solids
International Nuclear Information System (INIS)
Vitez, I.M.; Davidovich, M.; Newman, A.W.; Kiesnowski, C.
1998-01-01
A variety of techniques can be used to characterize the physical properties of pharmaceutical solids, including thermal analysis, hot-stage microscopy, X-ray powder diffraction, spectroscopic and micromeritic analysis. Comprehensive characterizations of the physical properties of pharmaceutical solids require a multi-disciplinary approach, since no single technique is capable of characterizing the materials completely.The combination of traditional hot-stage microscopy with new technologies such as high-resolution micrography, image capture, storage manipulation, and presentation, have permitted more comprehensive physical property characterizations to be conducted. As a result of these technological advances, it is possible to present the results of these microscopic analyses, as they were initially collected by the microscopist, outside of the laboratory.An evolutionary trail detailing the use of hot-stage microscopy in the Materials Science Group, from a simple melting point apparatus to the current hot-stage DSC microscopy instrument, will be presented. Examples of materials characterized using the hot-stage microscopy system will also be presented. (Copyright (c) 1998 Elsevier Science B.V., Amsterdam. All rights reserved.)
Energy Technology Data Exchange (ETDEWEB)
Galitsky, Christina; Galitsky, Christina; Chang, Sheng-chieh; Worrell, Ernst; Masanet, Eric
2008-03-01
The U.S. pharmaceutical industry consumes almost $1 billion in energy annually. Energy efficiency improvement is an important way to reduce these costs and to increase predictable earnings, especially in times of high energy price volatility. There are a variety of opportunities available at individual plants in the U.S. pharmaceutical industry to reduce energy consumption in a cost-effective manner. This Energy Guide discusses energy efficiency practices and energy efficient technologies that can be implemented at the component, process, system, and organizational levels. A discussion of the trends, structure, and energy consumption characteristics of the U.S. pharmaceutical industry is provided along with a description of the major process steps in the pharmaceutical manufacturing process. Expected savings in energy and energy-related costs are given for many energy efficiency measures, based on case study data from real-world applications in pharmaceutical and related facilities worldwide. Typical measure payback periods and references to further information in the technical literature are also provided, when available. The information in this Energy Guide is intended to help energy and plant managers reduce energy consumption in a cost-effective manner while meeting regulatory requirements and maintaining the quality of products manufactured. At individual plants, further research on the economics of the measures?as well as their applicability to different production practices?is needed to assess potential implementation of selected technologies.
Patent indicators: a window to pharmaceutical market success.
Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao
2013-07-01
Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.
78 FR 12365 - Sunshine Act Meeting
2013-02-22
... Institutional Advancement Committee will meet telephonically on February 26, 2013. The meeting will commence at... made of the closed session of the Board and Institutional Advancement Committee meetings. The... Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to...
High-speed precision weighing of pharmaceutical capsules
International Nuclear Information System (INIS)
Bürmen, Miran; Pernuš, Franjo; Likar, Boštjan
2009-01-01
In this paper, we present a cost-effective method for fast and accurate in-line weighing of hard gelatin capsules based on the optimized capacitance sensor and real-time processing of the capsule capacitance profile resulting from 5000 capacitance measurements per second. First, the effect of the shape and size of the capacitive sensor on the sensitivity and stability of the measurements was investigated in order to optimize the performance of the system. The method was tested on two types of hard gelatin capsules weighing from 50 mg to 650 mg. The results showed that the capacitance profile was exceptionally well correlated with the capsule weight with the correlation coefficient exceeding 0.999. The mean precision of the measurements was in the range from 1 mg to 3 mg, depending on the size of the capsule and was significantly lower than the 5% weight tolerances usually used by the pharmaceutical industry. Therefore, the method was found feasible for weighing pharmaceutical hard gelatin capsules as long as certain conditions are met regarding the capsule fill properties and environment stability. The proposed measurement system can be calibrated by using only two or three sets of capsules with known weight. However, for most applications it is sufficient to use only empty and nominally filled capsules for calibration. Finally, a practical application of the proposed method showed that a single system is capable of weighing around 75 000 capsules per hour, while using multiple systems could easily increase the inspection rate to meet almost any requirements
Arzhantsev, Sergey; Li, Xiang; Kauffman, John F
2011-02-01
We introduce a new method for analysis of X-ray fluorescence (XRF) spectra based on continuous wavelet transform filters, and the method is applied to the determination of toxic metals in pharmaceutical materials using hand-held XRF spectrometers. The method uses the continuous wavelet transform to filter the signal and noise components of the spectrum. We present a limit test that compares the wavelet domain signal-to-noise ratios at the energies of the elements of interest to an empirically determined signal-to-noise decision threshold. The limit test is advantageous because it does not require the user to measure calibration samples prior to measurement, though system suitability tests are still recommended. The limit test was evaluated in a collaborative study that involved five different hand-held XRF spectrometers used by multiple analysts in six separate laboratories across the United States. In total, more than 1200 measurements were performed. The detection limits estimated for arsenic, lead, mercury, and chromium were 8, 14, 20, and 150 μg/g, respectively.
Archives: Tropical Journal of Pharmaceutical Research
African Journals Online (AJOL)
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Archives: Nigerian Journal of Pharmaceutical Research
African Journals Online (AJOL)
Items 1 - 9 of 9 ... Archives: Nigerian Journal of Pharmaceutical Research. Journal Home > Archives: Nigerian Journal of Pharmaceutical Research. Log in or Register to get access to full text downloads.
Directory of Open Access Journals (Sweden)
N. O. Vetiutneva
2018-03-01
Full Text Available The aim of the work is the content analysis and methodological justification of the professional functions of the Responsible persons for quality assurance of medicines in pharmaceutical and hospital institutions. Materials and methods. The following research methods were used: system and comparative analysis, generalization, systematization, graphic modeling, observation. Research materials: normative legal acts, normative documents, recommendations of international organizations, information of wholesale and retail pharmaceutical companies, pharmaceutical and hospital institutions, professional non-governmental organizations, placed on official web-sites and collected in the process of direct observation. Results. The personnel and qualification aspects of professional activity of Responsible persons of pharmaceutical and hospital institutions were discussed. On the basis of analysis of the modern legal and regulatory framework, a general list of professional functions of the Responsible persons of health care institutions had been formed. The content analysis and comparison of the number of the functions of Responsible persons performed in health care institutions of different types is carried out. The new functions of the Responsible persons of health care institutions are considered. The managerial nature of the professional functions of the Responsible persons and the expediency of their complementing with the leadership functions are substantiated. On the basis of international management standards, requirements of GPP and GPEP, systematization of the functions of the Responsible persons of health care institutions in the groups and subgroups was performed. Conclusions. The generalization and systematization of the professional functions of the Responsible persons of health care institutions had been carried out for five classification groups of functions, namely: leadership, planning, organizational, control and information, of which the
Pharmaceutical technology management--profitable business avenue.
Puthli, Shivanand P
2010-01-01
Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.
Pharmaceutical care education in Kuwait: pharmacy students’ perspectives
Katoue, Maram G.; Awad, Abdelmoneim I.; Schwinghammer, Terry L.; Kombian, Samuel B.
2014-01-01
Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance...
Vulnerabilities to misinformation in online pharmaceutical marketing
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
2013-01-01
Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527
78 FR 59374 - Sunshine Act Meeting
2013-09-26
... Institutional Advancement Committee will meet telephonically on October 1, 2013. The meeting will commence at 4... meeting of the Institutional Advancement Committee. The transcript of any portion of the closed session... the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in...
78 FR 53480 - Sunshine Act Meeting
2013-08-29
... Institutional Advancement Committee will meet telephonically on September 3, 2013. The meeting will commence at... session meeting of the Institutional Advancement Committee. The transcript of any portion of the closed... Disabilities Act and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials...
78 FR 14839 - Sunshine Act Meeting
2013-03-07
... Institutional Advancement Committee will meet telephonically on March 12, 2013 and March 26, 2013. Each meeting... session meeting of the Institutional Advancement Committee. The transcript of any portion of the closed... Act and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials will...
78 FR 21978 - Sunshine Act Meeting
2013-04-12
... Institutional Advancement Committee will meet telephonically on April 23, 2013. The meeting will commence at 4... written transcript will be made of each closed session meeting of the Institutional Advancement Committee... the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in...
Pharmaceutical costs of assisted reproduction in Spain.
Lorente, Maria-Reyes; Hernández, Juana; Antoñanzas, Fernando
2013-11-01
Assisted reproduction is one of the health services currently being considered for possible limitation or exclusion from the public health services portfolio in Spain. One of the main reasons claimed for this is the impact on the budget for pharmaceutical expenditure. The objective of this study was to assess the significance of the pharmaceutical costs of assisted reproduction in Spain. This study focused on medical practice in Spain, and is based on the opinions of experts in assisted reproduction and the results provided by professional societies' publications. The reference year is 2012 and the setting was secondary care. We have included all existing pharmaceutical modalities for assisted reproduction, as well as the most common drug for each modality. We have considered the pharmaceutical cost per cycle for artificial insemination, in vitro fertilisation with or without intracytoplasmic sperm injection (IVF_ICSI), and cryotransfer and donated fresh oocytes reception. In Spain, artificial insemination has a pharmaceutical cost per cycle of between €69.36 and €873.79. This amounts to an average cycle cost of €364.87 for partner's sperm and €327.10 for donor sperm. The pharmaceutical cost of IVF_ICSI ranges between €278.16 and €1,902.66, giving an average cost per cycle of €1,139.65. In the case of cryotransfer and donated fresh oocytes reception, the pharmaceutical cost per cycle is between €22.61 and €58.73, yielding an average cost of €40.67. The budgetary impact of pharmaceutical expenditure for assisted reproduction in Spain for the year 2012 was estimated at €98.7 million. In Spain, the total pharmaceutical cost of assisted reproduction is substantial. According to our results, we can say that about 29% of the total pharmaceutical expenditure for assisted reproduction techniques is funded by the National Health System and the rest represents 2.4% of the total annual out-of-pocket family expenditure on drugs.
Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals
International Nuclear Information System (INIS)
Kulkarni, R.D.; Gopal, N.G.S.
1975-01-01
Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)
Directory of Open Access Journals (Sweden)
Geoffrey K Spurling
2010-10-01
Full Text Available BACKGROUND: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. METHODS AND FINDINGS: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise. Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008, International Pharmaceutical Abstracts (1970 to February 2008, Embase (1997 to February 2008, Current Contents (2001 to 2008, and Central (The Cochrane Library Issue 3, 2007 using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies and other sources (138 studies. Articles were then excluded because they did not fulfil inclusion criteria (179 or quality appraisal criteria (18, leaving 58 included studies with 87 distinct
[The role of biotechnology in pharmaceutical drug design].
Gaisser, Sibylle; Nusser, Michael
2010-01-01
Biotechnological methods have become an important tool in pharmaceutical drug research and development. Today approximately 15 % of drug revenues are derived from biopharmaceuticals. The most relevant indications are oncology, metabolic disorders and disorders of the musculoskeletal system. For the future it can be expected that the relevance of biopharmaceuticals will further increase. Currently, the share of substances in preclinical testing that rely on biotechnology is more than 25 % of all substances in preclinical testing. Products for the treatment of cancer, metabolic disorders and infectious diseases are most important. New therapeutic approaches such as RNA interference only play a minor role in current commercial drug research and development with 1.5 % of all biological preclinical substances. Investments in sustainable high technology such as biotechnology are of vital importance for a highly developed country like Germany because of its lack of raw materials. Biotechnology helps the pharmaceutical industry to develop new products, new processes, methods and services and to improve existing ones. Thus, international competitiveness can be strengthened, new jobs can be created and existing jobs preserved.
International Nuclear Information System (INIS)
1997-01-01
Recent exchange of operational safety experience among countries, within the framework of the IRS, revealed a noticeable increase in incidents involving foreign material intrusion (FMI) in nuclear power plant systems. These incidents appeared to have safety impact, sometimes widespread, on many systems and components, including the reactor core, control rods, the secondary side, and other support systems such as the electrical, air, and water systems. Notwithstanding the economic penalties and the operational problems that can arise from the FMI, many events indicated severe component damages, challenges to safety systems and to fuel integrity. Difficulties encountered with the removal of foreign material present further challenges due to the long term effects of such material remaining in the system and interacting with either fuel cladding, with the potential of releasing fission products in coolant systems, or with the system pressure boundary with the potential for material wear and sudden failure of the pressure boundary. The FMI topic was, therefore, one of a number of topics that was recommended by the TCM in 1996 for investigation. A consultant meeting was held at the IAEA during the period 14-18 April 1997 to address this topic. Figs
Naik, Shivangi; Hancock, Bruno; Abramov, Yuriy; Yu, Weili; Rowland, Martin; Huang, Zhonghui; Chaudhuri, Bodhisattwa
2016-04-01
Pharmaceutical powders are very prone to electrostatic charging by colliding and sliding contacts. In pharmaceutical formulation processes, particle charging is often a nuisance and can cause problems in the manufacture of products, such as affecting powder flow, fill, and dose uniformity. For a fundamental understanding of the powder triboelectrification, it is essential to study charge transfer under well-defined conditions. Hence, all experiments in the present study were conducted in a V-blender located inside a glove box with a controlled humidity of 20%. To understand tribocharging, different contact surfaces, namely aluminum, Teflon, poly methyl methacrylate, and nylon were used along with 2 pharmaceutical excipients and 2 drug substances. For the pharmaceutical materials, the work function values were estimated using MOPAC, a semiempirical molecular orbital package which has been previously used for the solid-state studies and molecular structure predictions. For a mechanistic understanding of tribocharging, a discrete element model incorporating charge transfer and electrostatic forces was developed. An effort was made to correlate tribocharging of pharmaceutical powders to properties such as cohesive energy density and surface energy. The multiscale model used is restricted as it considers only spherical particles with smooth surfaces. It should be used judiciously for other experimental assemblies because it does not represent a full validation of a tightly integrated model. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Pharmaceutical policy and the pharmacy profession
DEFF Research Database (Denmark)
Traulsen, Janine Marie; Almarsdóttir, Anna Birna
2005-01-01
In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and indu......In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy...... and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy...... in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental...
Pharmaceuticals: pharmaceutical cost controls--2005. End of Year Issue Brief.
Seay, Melicia; Varma, Priya
2005-12-31
The enactment of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) gave states the option of offering pharmaceutical benefits within their Medicaid programs. But the law placed restrictions on states' flexibility to control what prescriptions they would cover and required the states to reimburse outpatient prescription drugs from manufacturers that signed rebate agreements with the U.S. Department of Health and Human Services. Forty-nine states--Arizona is excluded, based on its program structure--and the District of Columbia currently offer prescription drug coverage under the Medicaid Drug Rebate Program. During the past four years, states all over the country have been plagued with revenue shortfalls in their state Medicaid budgets. While the fiscal situation improved for most states in the 2004 legislative session, many states still face budget pressures in 2005. Compounding existing budget pressures are threats from the Bush Administration to shift increased costs of the Medicaid program on to the states. All things considered, the economic pressure of funding Medicaid is at the top of legislative agendas in 2005. As in previous years, states are attempting to reduce costs to their Medicaid programs by seeking savings in their pharmaceutical programs. Prescription drug costs are highly attributed as a contributing factor to the fiscal climate of state Medicaid programs. Currently, prescription drug spending outpaces that of every other category of health care and drug prices are rising faster than inflation. In response, states are instituting a variety of pharmaceutical cost control measures such as creating preferred drug lists (PDLs), negotiating supplemental rebates, forming bulk purchasing pools, promoting generic drug substitution and implementing price controls. As prescription drug cost containment tools have gained acceptance and momentum, they continue to be controversial. This issue brief explores the debate, history, methodology, utilization
Pharmaceutical care education in Kuwait: pharmacy students' perspectives.
Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B
2014-07-01
Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients' quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. To investigate pharmacy students' attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists' physical separation from patient care areas (82.6%). Pharmacy students' attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and advocate implementation of pharmaceutical care while also
Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development
Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar
2016-01-01
Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...
[An analysis of the pharmaceuticals market in Vietnam].
Simonet, D
2001-01-01
This article sheds a light on the Vietnamese pharmaceutical market. The progress that has been made in the recent years following the opening of the Vietnamese regime to the western world, although not easy, brought a certain number of opportunities for domestic firms and foreign investors. The pharmaceutical Vietnamese industry started to emerge at the beginning of the 1990s. Although, the consumption of drugs is low, it does reach the sum of $ 5.5 per capita. As the majority of these products are imported, foreign companies tend to dominate the market both in volume and in diversity. The state has always played an important role with the implementation of a strict price control strategy and most national drug companies remain state-owned. The production and consumption of drugs were also largely influenced by state policies as the latter also control hospitals. In the second half of the eighties, the progressive liberalisation of the country allowed private drug pharmacies to appear and advertisement campaigns became legal. Because the lack of specific products like antibiotics was clear, the government increased the flow of imports, including private imports by citizens. Sources of imports have become more diverse, although France remains an important source of supply. Fournier, Lipha and Pierre Fabre are among the French drug manufacturers located in Vietnam. Other foreign companies include from India, South Korea, Thailand and Germany. Joint ventures were also created with French and Japanese companies. The import of medical materials is subjected to authorisations from the Ministry of Health and the Ministry of Foreign Trade as it is necessary to obtain a licence to do so. Licences are issued on the basis of the production of drugs that do not currently exist on the local market. But Vietnam also exports pharmaceutical products to Laos, Cambodia, and Cuba. Local resources constitute an important source of new products and have stirred a strong interest among
78 FR 20356 - Sunshine Act Meeting
2013-04-04
... Institutional Advancement Committee will meet telephonically on April 9, 2013. The meeting will commence at 4:00... verbatim written transcript will be made of each closed session meeting of the Institutional Advancement... Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to...
28 CFR 16.202 - Open meetings.
2010-07-01
... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Open meetings. 16.202 Section 16.202 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION Public Observation of Parole Commission Meetings § 16.202 Open meetings. (a) Every portion of every meeting of the...
Report of the consultants meeting on proper use of reference and control materials
International Nuclear Information System (INIS)
2002-01-01
Quality control in analytical laboratories as a basis of a complete quality system needs still to be developed in many Member States. To support the dissemination of information in this field a consultants meeting on 'Proper Use of Reference and Quality Control Materials' was held at the IAEA Headquarters, Vienna, from 13 to 17 August 2001. The experts convened with the objective to prepare a TECDOC to advise analytical laboratories in Member States on the correct use of Certified Reference Materials (CRMs) for Quality Control purposes and give practical recommendations to expand this concept to in-house Quality Control Materials (QCMs). In view of the existing literature in this field an urgent need for a practical guidebook for the preparation and application of cost effective and matrix matching QCMs was identified and the experts tried to fill this gap from their relevant experience. One and a half days of lecturing was followed by intensive discussion and brain storming to create a list of key words, which were structured in a logical order to provide a frame for the projected document. Responsibilities were assigned and deadlines fixed for the submission of the full text. (author)
Report of the consultants meeting on proper use of reference and control materials
Energy Technology Data Exchange (ETDEWEB)
NONE
2002-07-01
Quality control in analytical laboratories as a basis of a complete quality system needs still to be developed in many Member States. To support the dissemination of information in this field a consultants meeting on 'Proper Use of Reference and Quality Control Materials' was held at the IAEA Headquarters, Vienna, from 13 to 17 August 2001. The experts convened with the objective to prepare a TECDOC to advise analytical laboratories in Member States on the correct use of Certified Reference Materials (CRMs) for Quality Control purposes and give practical recommendations to expand this concept to in-house Quality Control Materials (QCMs). In view of the existing literature in this field an urgent need for a practical guidebook for the preparation and application of cost effective and matrix matching QCMs was identified and the experts tried to fill this gap from their relevant experience. One and a half days of lecturing was followed by intensive discussion and brain storming to create a list of key words, which were structured in a logical order to provide a frame for the projected document. Responsibilities were assigned and deadlines fixed for the submission of the full text. (author)
Biocatalytic Synthesis of Chiral Pharmaceutical Intermediates
Directory of Open Access Journals (Sweden)
Ramesh N. Patel
2004-01-01
Full Text Available The production of single enantiomers of drug intermediates has become increasingly important in the pharmaceutical industry. Chiral intermediates and fine chemicals are in high demand from both the pharmaceutical and agrochemical industries for the preparation of bulk drug substances and agricultural products. The enormous potential of microorganisms and enzymes for the transformation of synthetic chemicals with high chemo-, regio- and enantioselectivities has been demonstrated. In this article, biocatalytic processes are described for the synthesis of chiral pharmaceutical intermediates.
Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development
Directory of Open Access Journals (Sweden)
Dipak Dilip Gadade
2016-12-01
Full Text Available Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.
Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development.
Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar
2016-12-01
Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.
Organic Colouring Agents in the Pharmaceutical Industry
Directory of Open Access Journals (Sweden)
Šuleková M.
2017-09-01
Full Text Available Food dyes are largely used in the process of manufacturing pharmaceutical products. The aim of such a procedure is not only to increase the attractiveness of products, but also to help patients distinguish between pharmaceuticals. Various dyes, especially organic colouring agents, may in some cases have a negative impact on the human body. They are incorporated into pharmaceutical products including tablets, hard gelatine capsules or soft gelatine capsules, lozenges, syrups, etc. This article provides an overview of the most widely used colouring agents in pharmaceuticals, their characteristics and the EU legislation which regulates their use.
Lin, Angela Yu-Chen; Tsai, Yu-Ting
2009-06-01
We investigated the occurrence and distribution of pharmaceuticals (including antibiotics, estrogens, non-steroidal anti-inflammatory drugs (NSAIDs), beta-blockers, and lipid regulators) in three rivers and in the waste streams of six hospitals and four pharmaceutical production facilities in Taiwan. The most frequently detected pharmaceuticals were acetaminophen, erythromycin-H(2)O, sulfamethoxazole, and gemfibrozil. NSAIDs were the next most-often detected compounds, with a detection frequency >60%. The other analytes were not detected or were seen in only a few samples at trace concentrations. The present study demonstrates a significant discharge of human medications from hospital and drug production facilities into surface waters in the Taipei district. The high concentrations of pharmaceuticals found in the Sindian and Dahan rivers demonstrate the alarming degree to which they have been impacted by urban drainage (waste effluents from hospitals, households, and pharmaceutical production facilities). The ubiquitous occurrence at extremely high concentrations of acetaminophen and erythromycin-H(2)O in both rivers (up to 15.7 and 75.5 microg/L) and in wastewater from hospitals and pharmaceutical production facilities (up to 417.5 and 7.84 microg/L) was unique. This finding, in combination with acetaminophen's status as the drug most often prescribed by Taiwan's dominant clinical institute, suggests the potential use of acetaminophen as a molecular indicator of contamination of Taiwan's aqueous environments with untreated urban drainage.
Patrick Couvreur: inspiring pharmaceutical innovation.
Stanwix, Hannah
2014-05-01
Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.
Pharmaceutical Pill Counting and Inspection Using a Capacitive Sensor
Directory of Open Access Journals (Sweden)
Ganesan LETCHUMANAN
2008-01-01
Full Text Available A capacitive sensor for high-speed counting and inspection of pharmaceutical products is proposed and evaluated. The sensor is based on a patented Electrostatic Field Sensor (EFS device, previously developed by Sparc Systems Limited. However, the sensor head proposed in this work has a significantly different geometry and has been designed with a rectangular inspection aperture of 160mm × 21mm, which best meets applications where a larger count throughput is required with a single sensor. Finite element modelling has been used to simulate the electrostatic fields generated within the sensor, and as a design tool for optimising the sensor head configuration. The actual and simulated performance of the sensor is compared and analysed in terms of the sensor performance at discriminating between damaged products or detection of miscount errors.
Faleiros, Daniel Resende; Acurcio, Francisco de Assis; Álvares, Juliana; Nascimento, Renata Cristina Rezende Macedo do; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Leite, Silvana Nair; Karnikowski, Margô Gomes de Oliveira; Costa, Karen Sarmento; Guerra, Augusto Afonso
2017-11-13
medicines, as well as little concern about the formality in the use of public resources, expenses that meet individual demands to the detriment of the community, insufficient resources allocated to the Basic Component of Pharmaceutical Services, and exhaustion of the financing model.
Radiation treatment for sterilization of packaging materials
International Nuclear Information System (INIS)
Haji-Saeid, Mohammad; Sampa, Maria Helena O.; Chmielewski, Andrzej G.
2007-01-01
Treatment with gamma and electron radiation is becoming a common process for the sterilization of packages, mostly made of natural or synthetic plastics, used in the aseptic processing of foods and pharmaceuticals. The effect of irradiation on these materials is crucial for packaging engineering to understand the effects of these new treatments. Packaging material may be irradiated either prior to or after filling. The irradiation prior to filling is usually chosen for dairy products, processed food, beverages, pharmaceutical, and medical device industries in the United States, Europe, and Canada. Radiation effects on packaging material properties still need further investigation. This paper summarizes the work done by different groups and discusses recent developments in regulations and testing procedures in the field of packaging technology
A vision of the pharmaceutical industry.
Muñio, S
1998-01-01
As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.
FORMATION AND FURTHER DEVELOPMENT OF MODERN PROMOTION OF PHARMACEUTICAL PRODUCTS
Directory of Open Access Journals (Sweden)
Юрий Владимирович Тарасов
2014-02-01
Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2
Minimizing material damage using low temperature irradiation
International Nuclear Information System (INIS)
Craven, E.; Hasanain, F.; Winters, M.
2012-01-01
Scientific advancements in healthcare driven both by technological breakthroughs and an aging and increasingly obese population have lead to a changing medical device market. Complex products and devices are being developed to meet the demands of leading edge medical procedures. Specialized materials in these medical devices, including pharmaceuticals and biologics as well as exotic polymers present a challenge for radiation sterilization as many of these components cannot withstand conventional irradiation methods. The irradiation of materials at dry ice temperatures has emerged as a technique that can be used to decrease the radiation sensitivity of materials. The purpose of this study is to examine the effect of low temperature irradiation on a variety of polymer materials, and over a range of temperatures from 0 °C down to −80 °C. The effectiveness of microbial kill is also investigated under each of these conditions. The results of the study show that the effect of low temperature irradiation is material dependent and can alter the balance between crosslinking and chain scission of the polymer. Low temperatures also increase the dose required to achieve an equivalent microbiological kill, therefore dose setting exercises must be performed under the environmental conditions of use. - Highlights: ► A study is performed to quantify low temperature irradiation effects on polymer materials and BIs. ► Low temperature irradiation alters the balance of cross-linking and chain scissoning in polymers. ► Low temperatures provide radioprotection for BIs. ► Benefits of low temperatures are application specific and must be considered when dose setting.
Nontraditional roles for certified pharmacy technicians in a pharmaceutical company.
Fung, Stacey M; Gilmour, Christine; McCracken, David; Shane, Korban; Matsuura, Gary
2006-01-01
To describe nontraditional roles for Certified Pharmacy Technicians (CPhTs) within pharmaceutical industry. Drug information department within a large biotechnology/pharmaceutical organization. The Medical Communications department within Genentech uses a skills-mix staffing model in which employees with varying educational and training backgrounds work as a team on meeting the informational needs of consumers and health professionals who contact the company. One position within the department is that of Medical Communications Associate, responsible primarily for managing product inquiries. Medical Communications Associates have degrees in life sciences or an equivalent combination of education and experience, including a minimum of 2 years of related experience in the health care industry. Currently, four of the seven Medical Communications Associates in the department are CPhTs. Not applicable. Ability to recruit CPhTs for Medical Communications Associate positions, and job satisfaction of those hired into these positions. Critical basic skills needed for the Medical Communications Associate position include strong computer literacy, ability to multitask, and ability to work in an environment with frequent interruptions. Strong oral and written communications skills, customer service skills, ability to deal with stressful situations, product-specific knowledge, ability to work on a daily basis with Medical Communications Pharmacists, and knowledge of medical terminology are also important. The skills set of CPhTs matches these requirements, as evidenced by the experiences of the four staff members who have worked in the department for a total of 17 person-years. This nontraditional role for CPhTs can be rewarding and beneficial to all, affording an unique opportunity within the pharmaceutical industry. The skill set and experience of CPhTs can be used in the nontraditional pharmacy practice setting of drug information.
Three-dimensional printing in pharmaceutics: promises and problems.
Yu, Deng Guang; Zhu, Li-Min; Branford-White, Christopher J; Yang, Xiang Liang
2008-09-01
Three-dimensional printing (3DP) is a rapid prototyping (RP) technology. Prototyping involves constructing specific layers that uses powder processing and liquid binding materials. Reports in the literature have highlighted the many advantages of the 3DP system over other processes in enhancing pharmaceutical applications, these include new methods in design, development, manufacture, and commercialization of various types of solid dosage forms. For example, 3DP technology is flexible in that it can be used in applications linked to linear drug delivery systems (DDS), colon-targeted DDS, oral fast disintegrating DDS, floating DDS, time controlled, and pulse release DDS as well as dosage form with multiphase release properties and implantable DDS. In addition 3DP can also provide solutions for resolving difficulties relating to the delivery of poorly water-soluble drugs, peptides and proteins, preparation of DDS for high toxic and potent drugs and controlled-release of multidrugs in a single dosage forms. Due to its flexible and highly reproducible manufacturing process, 3DP has some advantages over conventional compressing and other RP technologies in fabricating solid DDS. This enables 3DP to be further developed for use in pharmaceutics applications. However, there are some problems that limit the further applications of the system, such as the selections of suitable excipients and the pharmacotechnical properties of 3DP products. Further developments are therefore needed to overcome these issues where 3DP systems can be successfully combined with conventional pharmaceutics. Here we present an overview and the potential 3DP in the development of new drug delivery systems.
Grainger-Rousseau, T J; Miralles, M A; Hepler, C D; Segal, R; Doty, R E; Ben-Joseph, R
1997-01-01
To design a pharmaceutical care model, and develop and field test a set of community pharmacy guidelines and practice support materials--Therapeutic Outcomes Monitoring (TOM) modules. Concept interviews with pharmacists, physicians, and patients; development and field testing of practice guidelines. Community pharmacies. Five independent, five chain, and two clinic site pharmacies. A prototype TOM module for asthma was developed through a seven-step process. Concept interviews were held with pharmacists, physicians, and patients to determine the desirability and feasibility of the TOM concept, prototype, and materials. Two field tests were completed and modifications made. Results were gathered through further concept interviews at the completion of the second field tests. Participants' opinions and experiences. Pharmacists, physicians, and patients expressed favorable attitudes about community pharmacists' participation in this pharmaceutical care model. Of the 12 participating pharmacists, 7 successfully implemented TOM in their practice sites and participated in the project throughout the testing; 49 patients were recruited into the study; and 22 patients remained in the program at the end of the second field test. In providing TOM services to these patients, the two most problematic areas for the pharmacists were in documenting care and reporting to physicians. A final phase of the TOM project has not been conducted in the United States because of insufficient numbers of patients for evaluating patient outcomes. The TOM project was successful from a technical but not a marketing perspective. Useful practice guidelines can be written and taught to pharmacists. Enrollment of patients was difficult, and the concept is not likely to spread spontaneously within the existing market for pharmaceutical services.
Pharmaceutical care education in Kuwait: pharmacy students’ perspectives
Directory of Open Access Journals (Sweden)
Katoue MG
2014-09-01
Full Text Available Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods: A descriptive, cross-sectional survey of pharmacy students (n=126 was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results: The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%, lack of pharmacist time (83.3%, organizational obstacles (82.6%, and pharmacists’ physical separation from patient care areas (82.6%. Conclusion: Pharmacy students’ attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University
Energy Technology Data Exchange (ETDEWEB)
NONE
2007-07-01
The 39th Annual Meeting of the Technical Working Group on Fast Reactors (TWG FR) was held from 15-19 May 2006 in Beijing, China, at the invitation of the China Institute of Atomic Energy (CIAEA). The meeting was attended by TWG-FR Members and Advisers from the following Member States (MS): Belgium (observer), Brazil, China, France, Germany, India, Italy, Japan, the Republic of Kazakhstan, the Republic of Korea, the Russian Federation, Sweden (observer), the United Kingdom, and the United States. Belarus, Switzerland, the European Commission, and OECD/NEA were unable to participate. Moreover, Prof. Carlo Rubbia, CERN director general emeritus, participated, upon IAEA invitation, in the meeting as distinguished scientist and IAEA expert. Mr. S.C. Chetal, from India (Indira Gandhi Centre for Atomic Research, IGCAR), was appointed chairman. The objectives of the meeting were to: - Exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); - Review the progress since the 38th TWG-FR Annual Meeting, including the status of the actions; - Consider meeting arrangements for 2006 and 2007; - Reviewed the Agency's ongoing information exchange and co-ordinated research activities in the technical fields relevant to the TWG-FR (FRs and ADS), as well as co-ordination of the TWG-FR's activities with other organizations; - Discuss future joint activities in view of the Agency's Programme and Budget Cycle 2008-2009 (and beyond)
Supply Chain Management in Zhendong Pharmaceutical Company
Li, Yan
2011-01-01
Medicines are special commodity related to people’s lives and health, therefore, pharmaceutical distribution is an industry affecting the national economy and the people's livelihood. With health care reform, changeable pharmaceutical policy and fiercely increasing competition in the medical industry, pharmaceutical distribution companies should improve their level of logistics operations and reduce overall logistics management costs in order to gain a leading position in the competition. In ...
[Fourcroy and pharmaceutical journals].
Bonnemain, Bruno
2011-04-01
Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.
Melocchi, Alice; Parietti, Federico; Maroni, Alessandra; Foppoli, Anastasia; Gazzaniga, Andrea; Zema, Lucia
2016-07-25
Fused deposition modeling (FDM) is a 3D printing technique based on the deposition of successive layers of thermoplastic materials following their softening/melting. Such a technique holds huge potential for the manufacturing of pharmaceutical products and is currently under extensive investigation. Challenges in this field are mainly related to the paucity of adequate filaments composed of pharmaceutical grade materials, which are needed for feeding the FDM equipment. Accordingly, a number of polymers of common use in pharmaceutical formulation were evaluated as starting materials for fabrication via hot melt extrusion of filaments suitable for FDM processes. By using a twin-screw extruder, filaments based on insoluble (ethylcellulose, Eudragit(®) RL), promptly soluble (polyethylene oxide, Kollicoat(®) IR), enteric soluble (Eudragit(®) L, hydroxypropyl methylcellulose acetate succinate) and swellable/erodible (hydrophilic cellulose derivatives, polyvinyl alcohol, Soluplus(®)) polymers were successfully produced, and the possibility of employing them for printing 600μm thick disks was demonstrated. The behavior of disks as barriers when in contact with aqueous fluids was shown consistent with the functional application of the relevant polymeric components. The produced filaments were thus considered potentially suitable for printing capsules and coating layers for immediate or modified release, and, when loaded with active ingredients, any type of dosage forms. Copyright © 2016 Elsevier B.V. All rights reserved.
NMR imaging and pharmaceutical sciences
International Nuclear Information System (INIS)
Beall, P.T.; Good, W.R.
1986-01-01
Described is the technique of NMR-imaging in diagnostic medicine. Proton and phosphorus NMR in diagnosis of abnormal tissue pathology. Discussed is the value of NMR to the pharmaceutical sciences. NMR may play an important role in monitoring the response of tissues to drugs, determining the localization of drugs, performing real time pharmacokinetics and testing the use of NMR contrast pharmaceuticals
Bioremediation Kinetics of Pharmaceutical Industrial Effluent
Directory of Open Access Journals (Sweden)
M. Šabić
2015-05-01
Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental
International Nuclear Information System (INIS)
Uher, M.; Benes, P.; Carsky, J.; Ctrnactova, H.; Fecenko, J.; Fellner, P.; Hodul, P.; Koprda, V.; Kratochvil, B.; Krkoska, P.; Kuruc, J.; Lehotay, J.; Matousek, J.; Milichovsky, P.; Omastova, M.; Petrus, L. jr.; Petrus, L. sr.; Schwendt, P.; Silny, P.; Sevcik, P.; Toma, S.; Uherova, R.; Zachar, P.
1999-09-01
The publication has been set up as a abstracts of the meeting dealing with different chemical problems. The book (Vol. 1) consists of the sections: All-plenary lectures (9 papers); (D) History of the chemistry (14); (K) Didactics of chemistry (32); The book (Vol. 2) consists of the sections: (A) Analytical chemistry (48); (B) Inorganic chemistry (75); (C) Physical chemistry (27); (F) Nuclear chemistry and radioecology (12); (L) Environmental chemistry and toxicology (33); (M) Agricultural chemistry (20). The book (Vol. 3) consists of the sections: (E) Wood, pulp, paper (15); (G) Macromolecular chemistry (42); (H) Organic chemistry, bio-organic chemistry and pharmaceutical chemistry (96); (I) Food chemistry and biochemistry (34); (J) Textile, fibres and foil materials (9). The book (Vol. 4) consists of the workshop Molecular models (3 papers)
Nurse practitioners' perceptions and participation in pharmaceutical marketing.
Crigger, Nancy; Barnes, Kristen; Junko, Autumn; Rahal, Sarah; Sheek, Casey
2009-03-01
This paper reports on a study conducted to describe family nurse practitioners' perceptions towards and participation in pharmaceutical marketing and to explore the relationships among related variables. The pharmaceutical industry's intense global marketing strategies have resulted in widespread concern in healthcare professionals and professional groups, sectors of the public in many countries, and in the World Health Organization. Research on healthcare providers' participation in pharmaceutical marketing indicates that these relationships are conflicts of interests and compromise healthcare providers' prescribing practices and trust. Nursing, as a discipline, appears to be slow to address the impact of pharmaceutical marketing on nursing practice. Questionnaires about perceptions and participation in pharmaceutical marketing were completed by a random sample of 84 licensed family nurse practitioners in the United States of America in 2007. Family nurse practitioners viewed pharmaceutical company marketing uncritically as educational and beneficial. They also perceived other providers but not themselves as influenced by pharmaceutical marketing. The findings supported those found in previous research with nurses and physicians. Lack of education, participation in marketing and psychological and social responses may impede family nurse practitioners' ability to respond critically and appropriately to marketing strategies and the conflict of interest it creates.
78 FR 9430 - Sunshine Act Meeting Notice
2013-02-08
... Corporation's Institutional Advancement Committee will meet telephonically on February 13, 2013. The meeting... will be made of the closed session of the Board and Institutional Advancement Committee meetings. The... Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to...
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2013-07-29
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78 FR 40515 - Sunshine Act Meeting Notice
2013-07-05
... Corporation's Institutional Advancement Committee will meet telephonically on July 9, 2013. The meeting will... transcript will be made of the closed session meeting of the Institutional Advancement Committee. The... the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in...
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2013-06-05
... Corporation's Institutional Advancement Committee will meet telephonically on June 11, 2013. The meeting will... transcript will be made of the closed session meeting of the Institutional Advancement Committee. The... and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be...
Pharmaceutical drug detailing in primary care: extent and methods
DEFF Research Database (Denmark)
Schramm, Jesper
The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's.......The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's....
EU pharmaceutical expenditure forecast.
Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher
2014-01-01
With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012-2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (-€9,367 million), France (-€5,589 million), and, far behind them
78 FR 26809 - Sunshine Act Meetings
2013-05-08
... Corporation's Institutional Advancement Committee will meet telephonically on May 14, 2013. The meeting will... Institutional Advancement Committee. The transcript of any portion of the closed session falling within the... Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to...
International Nuclear Information System (INIS)
van Veenendaal, M.
2008-01-01
The planning meeting was held May 21-23 2008 at Argonne National Laboratory (ANL). The purpose of the meeting was to establish a network on building computational model for resonant elastic and inelastic x-ray scattering. This course of action was recommended by program officer Dale Koelling after the initial submission of a proposal for a Computational Materials Science Network to Basic Energy Sciences. The meeting consisted of talks and discussion. At the end of the meeting three subgroups were formed. After the successful formation of the team, a new proposal was written which was funded by BES. Since this was a planning meeting there were no proceedings. The program and titles of talks are given.
The Impact of Biotechnology on Pharmaceutics.
Block, Lawrence H.
1990-01-01
The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…
Pharmaceutical counseling: Between evidence-based medicine and profits.
Egorova, S N; Akhmetova, T
2015-01-01
The number of pharmacies, which produce drug formulations locally, has recently considerably reduced in Russia. Pharmacies mainly operate as retailers of industrially manufactured drugs.Pharmaceutical consultation of customers at pharmacies aimed at responsible self-medication is the most popular and accessible feature of pharmaceutical care. In Russia there is a significant list of medicines approved for sale in pharmacies on a non-prescription basis that is specified in the product label. In this regard, the role of pharmacists in public health in Russia increases. Pharmacist, working directly with population, is an important figure for the rational use of medicines. This type of work requires high level of professional training and appropriate ethics. To explore the current status of pharmaceutical counseling in Russia. Situation analysis, surveys of pharmacists. Our experience in the system of postgraduate professional education, the results of the survey of pharmacists, and the long-term dialogue with pharmacists allowed us to identify several unresolved issues in the work of a pharmacist selling non-prescription drugs.Lack of differentiation in the functions of a pharmacist with a higher education and pharmaceutical technologist: In production/industrial pharmacy technicians are engaged in manufacturing of pharmaceutical formulations. However, due to the loss of production functions technologists had to move away from production laboratories of apothecaries to the sales area. Currently, the apothecary's assignment to receive prescriptions and dispense medications can be fulfilled by either a pharmacist or a pharmaceutical technician. It significantly discerns the pharmacy from the medical organization with clearly delineated functions of doctors and nurses. Russian regulations should consider the level of education required for high-quality pharmaceutical counseling.Contradiction between the pharmacist's special functions and trade procedure with the lack of
Postma, Maarten J; Milne, George; Nelson, E Anthony S; Pyenson, Bruce; Basili, Marcello; Coker, Richard; Oxford, John; Garrison, Louis P
2010-12-01
Model-based analyses built on burden-of-disease and cost-effectiveness theory predict that pharmaceutical interventions may efficiently mitigate both the epidemiologic and economic impact of an influenza pandemic. Pharmaceutical interventions typically encompass the application of (pre)pandemic influenza vaccines, other vaccines (notably pneumococcal), antiviral treatments and other drug treatment (e.g., antibiotics to target potential complications of influenza). However, these models may be too limited to capture the full macro-economic impact of pandemic influenza. The aim of this article is to summarize current health-economic modeling approaches to recognize the strengths and weaknesses of these approaches, and to compare these with more recently proposed alternative methods. We conclude that it is useful, particularly for policy and planning purposes, to extend modeling concepts through the application of alternative approaches, including insurers' risk theories, human capital approaches and sectoral and full macro-economic modeling. This article builds on a roundtable meeting of the Pandemic Influenza Economic Impact Group that was held in Boston, MA, USA, in December 2008.
The new generation of packing materials
International Nuclear Information System (INIS)
Malikov, T.S.; Dzhonmurodov, A.S.; Usmanova, S.R.; Teshaev, Kh.I.; Mukhidinov, Z.K.
2016-01-01
Present article is devoted to new generation of packing materials. The methods of extraction and investigation of component composition and properties of whey protein, zein, carboxymethylcellulose, hyaluronic acid and pectins were elaborated in order to further application them in pharmaceutical industry as composite materials and for capsulation of medicines.
Salt forms of the pharmaceutical amide dihydrocarbamazepine.
Buist, Amanda R; Kennedy, Alan R
2016-02-01
Carbamazepine (CBZ) is well known as a model active pharmaceutical ingredient used in the study of polymorphism and the generation and comparison of cocrystal forms. The pharmaceutical amide dihydrocarbamazepine (DCBZ) is a less well known material and is largely of interest here as a structural congener of CBZ. Reaction of DCBZ with strong acids results in protonation of the amide functionality at the O atom and gives the salt forms dihydrocarbamazepine hydrochloride {systematic name: [(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)(hydroxy)methylidene]azanium chloride, C15H15N2O(+)·Cl(-)}, dihydrocarbamazepine hydrochloride monohydrate {systematic name: [(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)(hydroxy)methylidene]azanium chloride monohydrate, C15H15N2O(+)·Cl(-)·H2O} and dihydrocarbamazepine hydrobromide monohydrate {systematic name: [(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)(hydroxy)methylidene]azanium bromide monohydrate, C15H15N2O(+)·Br(-)·H2O}. The anhydrous hydrochloride has a structure with two crystallographically independent ion pairs (Z' = 2), wherein both cations adopt syn conformations, whilst the two hydrated species are mutually isostructural and have cations with anti conformations. Compared to neutral dihydrocarbamazepine structures, protonation of the amide group is shown to cause changes to both the molecular (C=O bond lengthening and C-N bond shortening) and the supramolecular structures. The amide-to-amide and dimeric hydrogen-bonding motifs seen for neutral polymorphs and cocrystalline species are replaced here by one-dimensional polymeric constructs with no direct amide-to-amide bonds. The structures are also compared with, and shown to be closely related to, those of the salt forms of the structurally similar pharmaceutical carbamazepine.
Silva, Carla Patrícia; Jaria, Guilaine; Otero, Marta; Esteves, Valdemar I; Calisto, Vânia
2018-02-01
When adsorption is considered for water treatment, commercial activated carbon is usually the chosen adsorbent for the removal of pollutants from the aqueous phase, particularly pharmaceuticals. In order to decrease costs and save natural resources, attempts have been made to use wastes as raw materials for the production of alternative carbon adsorbents. This approach intends to increase efficiency, cost-effectiveness, and also to propose an alternative and sustainable way for the valorization/management of residues. This review aims to provide an overview on waste-based adsorbents used on pharmaceuticals' adsorption. Experimental facts related to the adsorption behaviour of each adsorbent/pharmaceutical pair and some key factors were addressed. Also, research gaps that subsist in this research area, as well as future needs, were identified. Simultaneously, this review aims to clarify the current status of the research on pharmaceuticals' adsorption by waste-based adsorbents in order to recognize if the right direction is being taken. Copyright © 2017 Elsevier Ltd. All rights reserved.
Directory of Open Access Journals (Sweden)
Dewi Hanggraeni
2014-08-01
Full Text Available As one of the biggest medicines market in the South East Asia, the pharmaceutical industry inIndonesia has a huge potential market. However, the majority supply of raw materials has been imported.Besides, regulations of the Health Ministry and the Trade Ministry have still hampered mostplayers in Indonesia pharmaceutical industry. Therefore, this study used Data Envelopment Analysis(DEA models to analyze efficiency and productivity change in the Indonesian pharmaceutical industrybetween 2006 and 2011, listed in the Indonesia Stock Exchange and also supported by applyingefficiency financial ratio. This study finds that the decision for the most relatively efficient companyis different using DEA compared to efficiency financial ratios, yet DEA has better measurement ofefficiency. It is proven by one of State-owned Enterprises has been evaluated underperformed by thefinancial ratio analysis, unexpectedly is efficient using the DEA approach. This study has also proposedand tested a hypothesis on the average efficiency to check if the domestic and foreign pharmaceuticalcompanies differ in their efficiency but the result implies that there is no significant statisticaldifference among them. This study indicates that firms having dominant contribution in selling overthe-counter medicines are more efficient than selling ethical medicines. Lastly, technological changecontribution has more influence to productivity change instead of pure technical efficiency change inIndonesia pharmaceutical companies.
[The aspects of pricing policy in Azerbaijan pharmaceutical sector].
Dzhalilova, K I; Alieva, K Ia
2012-01-01
The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceutical companies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers.
Uptake and depuration of pharmaceuticals in aquatic invertebrates
International Nuclear Information System (INIS)
Meredith-Williams, Melanie; Carter, Laura J.; Fussell, Richard; Raffaelli, David; Ashauer, Roman; Boxall, Alistair B.A.
2012-01-01
The uptake and depuration of a range of pharmaceuticals in the freshwater shrimp (Gammarus pulex) and the water boatman (Notonecta glauca) was studied. For one compound, studies were also done using the freshwater snail Planobarius corneus. In G. pulex, bioconcentration factors (BCFs) ranged from 4.6 to 185,900 and increased in the order moclobemide < 5-fluoruracil < carbamazepine < diazepam < carvedilol < fluoxetine. In N. glauca BCFs ranged from 0.1 to 1.6 and increased in the order 5-fluorouracil < carbamazepine < moclobemide < diazepam < fluoxetine < carvedilol. For P. corneus, the BCF for carvedilol was 57.3. The differences in degree of uptake across the three organisms may be due to differences in mode of respiration, behaviour and the pH of the test system. BCFs of the pharmaceuticals for each organism were correlated to the pH-corrected liposome–water partition coefficient of the pharmaceuticals. - Highlights: ► One of the first studies exploring the uptake of pharmaceuticals into aquatic invertebrates. ► Data presented on uptake, depuration rates and bioconcentration for a range of pharmaceuticals. ► Uptake is correlated with the pH-corrected liposome–water partition coefficient. ► Findings can be used to better predict impacts of pharmaceuticals on the aquatic environment. - The factors affecting the degree of uptake of pharmaceuticals into aquatic invertebrates were studied. The results indicate that species traits such as respiration and behaviour of the organisms and pH-corrected liposome–water partition coefficients are important factors in determining pharmaceutical uptake.
Dropwise additive manufacturing of pharmaceutical products for solvent-based dosage forms.
Hirshfield, Laura; Giridhar, Arun; Taylor, Lynne S; Harris, Michael T; Reklaitis, Gintaras V
2014-02-01
In recent years, the US Food and Drug Administration has encouraged pharmaceutical companies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.
Pharmaceutical portfolio management: global disease burden and corporate performance metrics.
Daems, Rutger; Maes, Edith; Mehra, Maneesha; Carroll, Benjamin; Thomas, Adrian
2014-09-01
Biopharmaceutical companies face multiple external pressures. Shareholders demand a profitable company while governments, nongovernmental third parties, and the public at large expect a commitment to improving health in developed and, in particular, emerging economies. Current industry commercial models are inadequate for assessing opportunities in emerging economies where disease and market data are highly limited. The purpose of this article was to define a conceptual framework and build an analytic decision-making tool to assess and enhance a company's global portfolio while balancing its business needs with broader social expectations. Through a case-study methodology, we explore the relationship between business and social parameters associated with pharmaceutical innovation in three distinct disease areas. The global burden of disease-based theoretical framework using disability-adjusted life-years provides an overview of the burden associated with particular diseases. The social return on investment is expressed as disability-adjusted life-years averted as a result of the particular pharmaceutical innovation. Simultaneously, the business return on investment captures the research and development costs and projects revenues in terms of a profitability index. The proposed framework can assist companies as they strive to meet the medical needs of populations around the world for decades to come. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)
Find environmental regulatory and compliance information for the pharmaceutical manufacturing sector, including essential uses of CFCs, NESHAP for pharmaceutical production, effluent guidelines for wastewater and management of hazardous waste.
Microstructure of Tablet-Pharmaceutical Significance, Assessment, and Engineering.
Sun, Changquan Calvin
2017-05-01
To summarize the microstructure - property relationship of pharmaceutical tablets and approaches to improve tablet properties through tablet microstructure engineering. The main topics reviewed here include: 1) influence of material properties and manufacturing process parameters on the evolution of tablet microstructure; 2) impact of tablet structure on tablet properties; 3) assessment of tablet microstructure; 4) development and engineering of tablet microstructure. Microstructure plays a decisive role on important pharmaceutical properties of a tablet, such as disintegration, drug release, and mechanical strength. Useful information on mechanical properties of a powder can be obtained from analyzing tablet porosity-pressure data. When helium pycnometry fails to accurately measure true density of a water-containing powder, non-linear regression of tablet density-pressure data is a useful alternative method. A component that is more uniformly distributed in a tablet generally exerts more influence on the overall tablet properties. During formulation development, it is highly recommended to examine the relationship between any property of interest and tablet porosity when possible. Tablet microstructure can be engineered by judicious selection of formulation composition, including the use of the optimum solid form of the drug and appropriate type and amount of excipients, and controlling manufacturing process.
A model of the prescription-pharmaceutical sales process
Directory of Open Access Journals (Sweden)
Michael Stros
2018-06-01
Full Text Available The purpose of this paper is to determine the factors in marketing most relevant to achieving pharmaceutical sales success and their interrelations, as well as providing a prescription-pharmaceuticals sales process model. This will enable scholars to obtain a better understanding of the marketing process for prescription pharmaceuticals, as well as enabling marketers to apply more efficient marketing approaches. The study uses a unique data set, combining primary data and secondary data from the Swiss prescription-pharmaceuticals market. The data is analysed using a multiple-regression based model. A multi-level data structure is found, suggesting that factors concerning the specific brand and also the pharmaceutical substance itself are relevant to sales success. It is revealed that the factors most relevant to sales success are: order of market entry, perceived product-quality, average price, and marketing expenditures, leading to practical recommendations for scholars and marketing professionals. The study focuses only on the Swiss prescription-pharmaceuticals market, investigating five medical drug classes. The assumption is made that these results can be generalised to similar markets and drug classes. The study develops a conceptual prescription-pharmaceuticals sales-process model; offers practical guidelines and a good basis for further scholarly research are provided; and identifies several research gaps by giving proposals for future research.
Toward a Regional Research Agenda on Pharmaceutical ...
International Development Research Centre (IDRC) Digital Library (Canada)
African policymakers are pushing for local pharmaceutical manufacturing as a ... Africa Development Community Pharmaceutical Business Plan (2007-2013) and ... IDRC congratulates first cohort of Women in Climate Change Science Fellows.
Control of three different continuous pharmaceutical manufacturing processes: Use of soft sensors.
Rehrl, Jakob; Karttunen, Anssi-Pekka; Nicolaï, Niels; Hörmann, Theresa; Horn, Martin; Korhonen, Ossi; Nopens, Ingmar; De Beer, Thomas; Khinast, Johannes G
2018-05-30
One major advantage of continuous pharmaceutical manufacturing over traditional batch manufacturing is the possibility of enhanced in-process control, reducing out-of-specification and waste material by appropriate discharge strategies. The decision on material discharge can be based on the measurement of active pharmaceutical ingredient (API) concentration at specific locations in the production line via process analytic technology (PAT), e.g. near-infrared (NIR) spectrometers. The implementation of the PAT instruments is associated with monetary investment and the long term operation requires techniques avoiding sensor drifts. Therefore, our paper proposes a soft sensor approach for predicting the API concentration from the feeder data. In addition, this information can be used to detect sensor drift, or serve as a replacement/supplement of specific PAT equipment. The paper presents the experimental determination of the residence time distribution of selected unit operations in three different continuous processing lines (hot melt extrusion, direct compaction, wet granulation). The mathematical models describing the soft sensor are developed and parameterized. Finally, the suggested soft sensor approach is validated on the three mentioned, different continuous processing lines, demonstrating its versatility. Copyright © 2018 Elsevier B.V. All rights reserved.
DEFF Research Database (Denmark)
Mortier, S.T.F.C.; Vedantam, S.; De Beer, T.
Tablets are conventionally produced via consecutive batch process steps. Recent introduction of continuous process equipment is gaining industrial importance in pharmaceutics. Transition to continuous production requires improved understanding of all operations, necessitating the development...... of mechanistic models of multi‐phase systems which in the end allow process control. This contribution focuses on continuous fluidized bed drying of pharmaceutical wet granules. A stepwise approach is used in model development, starting with the drying behaviour of single granules. Experiments to determine...
Iuraş, Andreea; Scurr, David J; Boissier, Catherine; Nicholas, Mark L; Roberts, Clive J; Alexander, Morgan R
2016-04-05
The structure of a material, in particular the extremes of crystalline and amorphous forms, significantly impacts material performance in numerous sectors such as semiconductors, energy storage, and pharmaceutical products, which are investigated in this paper. To characterize the spatial distribution for crystalline-amorphous forms at the uppermost molecular surface layer, we performed time-of-flight secondary-ion mass spectroscopy (ToF-SIMS) measurements for quench-cooled amorphous and recrystallized samples of the drugs indomethacin, felodipine, and acetaminophen. Polarized light microscopy was used to localize crystallinity induced in the samples under controlled conditions. Principal component analysis was used to identify the subtle changes in the ToF-SIMS spectra indicative of the amorphous and crystalline forms for each drug. The indicators of amorphous and crystalline surfaces were common in type across the three drugs, and could be explained in general terms of crystal packing and intermolecular bonding, leading to intramolecular bond scission in the formation of secondary ions. Less intramolecular scission occurred in the amorphous form, resulting in a greater intensity of molecular and dimer secondary ions. To test the generality of amorphous-crystalline differentiation using ToF-SIMS, a different recrystallization method was investigated where acetaminophen single crystals were recrystallized from supersaturated solutions. The findings indicated that the ability to assign the crystalline/amorphous state of the sample using ToF-SIMS was insensitive to the recrystallization method. This demonstrates that ToF-SIMS is capable of detecting and mapping ordered crystalline and disordered amorphous molecular materials forms at micron spatial resolution in the uppermost surface of a material.
International Nuclear Information System (INIS)
2008-01-01
The objectives of the meeting were to: - Exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); - Review the progress since the 40th TWG-FR Annual Meeting, including the status of the actions; - Consider meeting arrangements for 2008, 2009, 2010 and beyond; - Review the IAEA’s ongoing information exchange and coordinated research activities in the technical fields relevant to the TWG-FR (FRs and ADS), as well as coordination of the TWG-FR’s activities with other organizations and international initiatives; - Discuss future joint activities in view of IAEA’s Programme and Budget Cycles beyond 2008-2009
Pharmaceutical product cross-contamination: industrial and clinical ...
African Journals Online (AJOL)
problems. Pharmaceutical product cross-contamination is a serious problem which has been detected as an obstacle ... In the pharmaceutical care of patients in developed countries, cross-contamination ..... neonatal intensive care units.
Quality Systems Implementation in the Pharmaceutical Industry
African Journals Online (AJOL)
Nafiisah
quality standards imposed on local pharmaceutical manufacturers. Keywords: Quality/ .... GMP is concerned with both production and quality control. It is aimed ... in the European pharmaceutical industry in designing their quality systems:.
PHARMACEUTICAL COMPANIES BETWEEN CRISIS AND COMPETITIVENESS - SECTORAL DIAGNOSIS
Directory of Open Access Journals (Sweden)
Mihaela\tBÎRSAN
2015-06-01
Full Text Available The evolution of the pharmaceutical industry was a positive constant with the indicators of industrial production even in years of crisis. Although the economic crisis in Romania decreased average growth rate of pharmaceutical companies, market value is expected to increase. The explanation comes from the fact that in order to boost productivity, pharmaceutical companies are turning to emerging countries with aging populations such as open new markets for future development. Add to this the recent health policies implemented by newly industrialized countries that are aimed at ensuring increased access to care. Analysts see the field phenomenon called "Farma-merger" a good chance for European pharmaceutical companies oriented to developing countries where drug sales should record a double-digit annual growth until 2017. In Erste Group reports stated that the impact of the crisis on the pharmaceutical industry should be limited markets for EU only their economic slowdown. This will be possible because the external indebtedness of pharmaceutical companies in the EU remains at a minimum, they are able to finance their investment plans without tapping financial markets, are not adversely affected by the current limited availability of credit resources. Therefore major pharmaceutical companies in the EU will remain a solid investment on the long term, the negative developments are limited due to high resistance to the crisis their business model segment "generic". The consequence of these developments is reflected in the recognition for the first time, the pharmaceutical sector as a strategic sector for the Romanian economy. In the context of public debate launching the National Strategy for Competitiveness 2014-2020, Generic Medicines Industry Association of Romania (APMGR local pharmaceutical industry reminds the Government proposals on correcting the current fiscal and operational regulatory framework, to allow unlocking investments in facilities
EDITORIAL The 23rd Nordic Semiconductor Meeting The 23rd Nordic Semiconductor Meeting
Ólafsson, Sveinn; Sveinbjörnsson, Einar
2010-12-01
A Nordic Semiconductor Meeting is held every other year with the venue rotating amongst the Nordic countries of Denmark, Finland, Iceland, Norway and Sweden. The focus of these meetings remains 'original research and science being carried out on semiconductor materials, devices and systems'. Reports on industrial activity have usually featured. The topics have ranged from fundamental research on point defects in a semiconductor to system architecture of semiconductor electronic devices. Proceedings from these events are regularly published as a topical issue of Physica Scripta. All of the papers in this topical issue have undergone critical peer review and we wish to thank the reviewers and the authors for their cooperation, which has been instrumental in meeting the high scientific standards and quality of the series. This meeting of the 23rd Nordic Semiconductor community, NSM 2009, was held at Háskólatorg at the campus of the University of Iceland, Reykjavik, Iceland, 14-17 June 2009. Support was provided by the University of Iceland. Almost 50 participants presented a broad range of topics covering semiconductor materials and devices as well as related material science interests. The conference provided a forum for Nordic and international scientists to present and discuss new results and ideas concerning the fundamentals and applications of semiconductor materials. The meeting aim was to advance the progress of Nordic science and thus aid in future worldwide technological advances concerning technology, education, energy and the environment. Topics Theory and fundamental physics of semiconductors Emerging semiconductor technologies (for example III-V integration on Si, novel Si devices, graphene) Energy and semiconductors Optical phenomena and optical devices MEMS and sensors Program 14 June Registration 13:00-17:00 15 June Meeting program 09:30-17:00 and Poster Session I 16 June Meeting program 09:30-17:00 and Poster Session II 17 June Excursion and dinner
Ridgway, Cathy; Bawuah, Prince; Markl, Daniel; Zeitler, J Axel; Ketolainen, Jarkko; Peiponen, Kai-Erik; Gane, Patrick
2017-06-30
The physical properties and mechanical integrity of pharmaceutical tablets are of major importance when loading with active pharmaceutical ingredient(s) (API) in order to ensure ease of processing, control of dosage and stability during transportation and handling prior to patient consumption. The interaction between API and excipient, acting as functional extender and binder, however, is little understood in this context. The API indomethacin is combined in this study with microcrystalline cellulose (MCC) at increasing loading levels. Tablets from the defined API/MCC ratios are made under conditions of controlled porosity and tablet thickness, resulting from different compression conditions, and thus compaction levels. Mercury intrusion porosimetry is used to establish the accessible pore volume, pore size distribution and, adopting the observed region of elastic intrusion-extrusion at high pressure, an elastic bulk modulus of the skeletal material is recorded. Porosity values are compared to previously published values derived from terahertz (THz) refractive index data obtained from exactly the same tablet sample sets. It is shown that the elastic bulk modulus is dependent on API wt% loading under constant tablet preparation conditions delivering equal dimensions and porosity. The findings are considered of novel value in respect to establishing consistency of tablet production and optimisation of physical properties. Copyright © 2017 Elsevier B.V. All rights reserved.
A new e-beam application in the pharmaceutical industry
International Nuclear Information System (INIS)
Sadat, Theo; Malcolm, Fiona
2005-01-01
The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a 'miniature' low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned
Liu, Cheng-Hua; Zhang, Yingjie; Bhalsod, Gemini; Chuang, Ya-Hui; Boyd, Stephen; Teppen, Brian; Tiedje, James; Li, Hui; Zhang, Wei
2016-04-01
Pharmaceuticals are emerging contaminants widely detected in soil and water environments, and concerns are mounting over their potential impact on human and ecosystem health. In particular, overuse of antibiotics (an important group of pharmaceuticals) in human medicine and animal agriculture and rapid emergence of antibiotic resistant bacteria on a global scale are threatening the health of humans, animals, and the environment. We have investigated interactions of pharmaceuticals with pyrogenic carbon geosorbents (e.g., biohar and activated carbon), bacteria, and vegetable crops in order to better understand sorption, uptake, and translocation of pharmaceuticals in the soil-water-biota continuum. Sorption of antibiotics by biochars was studied to assess the effect of biochar soil amendment in reducing the transport and bioavailability of antibiotics. Pyrogenic carbonaceous materials such as biochars and activated carbon had strong sorption capacities for antibiotics, and drastically lowed the uptake of antibiotics by an Escherichia coli, therefore demonstrating soil amendment with pyrogenic carbon geosorbents as an effective remediation strategy to reduce antibiotic transport and selection pressure for antibiotic resistant bacteria. Additionally, because consuming pharmaceutical-tainted food is a direct human exposure pathway, it is critical to investigate the residue levels of pharmaceuticals in food crops grown in contaminated soils or irrigated with reclaimed water. Therefore, we have studied the uptake and accumulations of pharmaceuticals in greenhouse-grown lettuce under overhead or surface irrigations. Preliminary results indicate that pharmaceuticals of large molecular weight and low water solubility had greater concentrations in lettuce shoots under overhead irrigation than surface irrigation. Pharmaceuticals of low molecular weight and high water solubility are less clearly influenced by irrigation methods. These results implies that irrigation scheme
Directory of Open Access Journals (Sweden)
Kamal Uddin Zaidi
2014-01-01
Full Text Available Tyrosinase is a natural enzyme and is often purified to only a low degree and it is involved in a variety of functions which mainly catalyse the o-hydroxylation of monophenols into their corresponding o-diphenols and the oxidation of o-diphenols to o-quinones using molecular oxygen, which then polymerizes to form brown or black pigments. The synthesis of o-diphenols is a potentially valuable catalytic ability and thus tyrosinase has attracted a lot of attention with respect to industrial applications. In environmental technology it is used for the detoxification of phenol-containing wastewaters and contaminated soils, as biosensors for phenol monitoring, and for the production of L-DOPA in pharmaceutical industries, and is also used in cosmetic and food industries as important catalytic enzyme. Melanin pigment synthesized by tyrosinase has found applications for protection against radiation cation exchangers, drug carriers, antioxidants, antiviral agents, or immunogen. The recombinant V. spinosum tryosinase protein can be used to produce tailor-made melanin and other polyphenolic materials using various phenols and catechols as starting materials. This review compiles the recent data on biochemical and molecular properties of microbial tyrosinases, underlining their importance in the industrial use of these enzymes. After that, their most promising applications in pharmaceutical, food processing, and environmental fields are presented.
Pharmaceutical regulation in 15 European countries review.
Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard
2016-10-01
In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).
International Nuclear Information System (INIS)
Joshi, S.K.; Rao, C.N.R.; Tsuruta, T.
1992-01-01
The book contains the state-of-the art lectures delivered at the discussion meeting on new materials, a field in which rapid advances are taking place. The main objective of the meeting was to bring active scientists in this area from Japan and India together. The topics covered diverse aspects of modern materials including high temperature superconducting compounds. (M.G.B.)
Cleaner production at pharmaceutical industry: first steps assessment
Directory of Open Access Journals (Sweden)
Edilaine Conceição Rezende
2015-12-01
Full Text Available The Cleaner Production (CP is an environmental management system effective to comply the environmental obligations and promote sustainable development of enterprises. In this study, the implementing possibilities of CP practices were evaluated to pharmaceutical industry, through prior identification procedures for Pharmaceutical Manufacturing Practices. The study was conducted in a scientific and health care institution, which produces pharmaceutical drugs and makes assistance for public health. The production process was evaluated and made a survey of the main points of waste and sewage generations in each stage, in order to diagnose the measures of CP established and propose new actions. Thus, by using this tool, it was possible to demonstrate the reduction of environmental impacts associated with pharmaceutical production. The Pharmaceutical Manufacturing Practices also contributed to the implementation of measures CP, preserving the final product quality, and generating environmental and economic benefits.
The "Total Immersion" Meeting Environment.
Finkel, Coleman
1980-01-01
The designing of intelligently planned meeting facilities can aid management communication and learning. The author examines the psychology of meeting attendance; architectural considerations (lighting, windows, color, etc.); design elements and learning modes (furniture, walls, audiovisuals, materials); and the idea of "total immersion meeting…
Division of Materials Science (DMS) meeting presentation
Energy Technology Data Exchange (ETDEWEB)
Cline, C.F.; Weber, M.J.
1982-11-08
Materials preparation techniques are listed. Materials preparation capabilities are discussed for making BeF/sub 2/ glasses and other materials. Materials characterization techniques are listed. (DLC)
Directory of Open Access Journals (Sweden)
Carina Akemi Nakamura
2014-12-01
Full Text Available The objective of this study was to investigate the scientific output on health promotion within the pharmaceutical field and its relation with the development of pharmaceutical services within health systems. A comprehensive review of published scientific articles from the Medline and Lilacs databases was carried out. The review comprised articles published until December 2011, and used combinations of the terms 'health promotion' or 'health education' and 'pharmacy', 'pharmacist' or 'pharmaceutical'. The articles were selected according to inclusion and exclusion criteria. A total of 170 full texts and 87 indexed abstracts were analyzed, evidencing that most described actions of health promotion in community pharmacies and other services. Following the Ottawa Charter, most of the studies dealt with new guidance of the service and the supply of pharmaceutical information and services. It was concluded that there is a lack of theoretical background on health promotion in the pharmaceutical field to sustain the professional education and practice required by the health system and the population.
Ali, Nasar; De Hosson, Jeff. Th. M.; Ahmed, W.
The International Meeting on Developments in Materials, Processes and Applications of Nanotechnology (MPA 2008) held at Robinson College, University of Cambridge, UK was the second event of the MPA conference series. The first MPA-2007, held at the University of Ulster, UK officially launched the
East and Central African Journal of Pharmaceutical Sciences An ...
African Journals Online (AJOL)
An Approach to Effective Disinfection of Salon Items [clippers, combs and scissors]. O.S. OLONITOLA'*, P.F. OLURINOLA~ ... 2~epartment of Pharmaceutics and Pharmaceutical Microbiology, Faculty of Pharmaceutical. Sciences, Ahmadu Bello ... antimicrobial products with increased value over those currently available.
Pharmaceutical care in Brazil’s primary health care
Directory of Open Access Journals (Sweden)
Patricia Sodré Araújo
2017-11-01
Full Text Available ABSTRACT OBJECTIVE To characterize the activities of clinical nature developed by pharmacists in basic health units and their participation in educational activities aiming at health promotion. METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015, a cross-sectional and exploratory study, of evaluative nature, consisting of a survey of information in a representative sample of cities, stratified by the Brazilian regions that constitute domains of study, and a subsample of primary health care services. The interviewed pharmacists (n=285 were responsible for the delivery of medicines and were interviewed in person with the use of a script. The characterization of the activities of clinical nature was based on information from pharmacists who declared to perform them, and on participation in educational activities aiming at health promotion, according to information from all pharmacists. The results are presented in frequency and their 95% confidence intervals. RESULTS From the interviewed subjects, 21.3% said they perform activities of clinical nature. Of these, more than 80% considered them very important; the majority does not dispose of specific places to perform them, which hinders privacy and confidentiality in these activities. The main denominations were “pharmaceutical guidance” and “pharmaceutical care.” The registration of activities is mainly made in the users’ medical records, computerized system, and in a specific document filed at the pharmacy, impairing the circulation of information among professionals. Most pharmacists performed these activities mainly along with physicians and nurses; 24.7% rarely participated in meetings with the health team, and 19.7% have never participated. CONCLUSIONS Activities of clinical nature
Energy Technology Data Exchange (ETDEWEB)
NONE
2005-07-01
approaches are used nationally and a review of the regulation of NORM is timely. The mining and milling of uranium and thorium ores and the management of the waste generated from such activities is the subject of several safety documents of the IAEA. An assessment of occupational protection conditions in workplaces with high levels of exposure to natural radiation was made through an IAEA Technical Committee Meeting held in 2001. The findings of this meeting are forming the basis for a work plan for future activities in this area and for a Safety Guide on occupational radiation protection in mining and processing of raw material, as well as two related safety reports. However, there is a range of radiation protection issues, arising from the mining, processing, utilisation and disposal of NORM, which have not yet been covered in IAEA safety documents. These include impacts on the public and the environment of the processing of NORM and the associated generation of waste.
International Nuclear Information System (INIS)
2005-01-01
approaches are used nationally and a review of the regulation of NORM is timely. The mining and milling of uranium and thorium ores and the management of the waste generated from such activities is the subject of several safety documents of the IAEA. An assessment of occupational protection conditions in workplaces with high levels of exposure to natural radiation was made through an IAEA Technical Committee Meeting held in 2001. The findings of this meeting are forming the basis for a work plan for future activities in this area and for a Safety Guide on occupational radiation protection in mining and processing of raw material, as well as two related safety reports. However, there is a range of radiation protection issues, arising from the mining, processing, utilisation and disposal of NORM, which have not yet been covered in IAEA safety documents. These include impacts on the public and the environment of the processing of NORM and the associated generation of waste
Pharmaceutical companies and healthcare providers: Going beyond the gift – An explorative review
Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk
2018-01-01
Introduction Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. Material and methods We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Results Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. Discussion and conclusion The effects of bilateral interactions reported in the literature are
Photoredox-catalyzed deuteration and tritiation of pharmaceutical compounds.
Loh, Yong Yao; Nagao, Kazunori; Hoover, Andrew J; Hesk, David; Rivera, Nelo R; Colletti, Steven L; Davies, Ian W; MacMillan, David W C
2017-12-01
Deuterium- and tritium-labeled pharmaceutical compounds are pivotal diagnostic tools in drug discovery research, providing vital information about the biological fate of drugs and drug metabolites. Herein we demonstrate that a photoredox-mediated hydrogen atom transfer protocol can efficiently and selectively install deuterium (D) and tritium (T) at α-amino sp 3 carbon-hydrogen bonds in a single step, using isotopically labeled water (D 2 O or T 2 O) as the source of hydrogen isotope. In this context, we also report a convenient synthesis of T 2 O from T 2 , providing access to high-specific-activity T 2 O. This protocol has been successfully applied to the high incorporation of deuterium and tritium in 18 drug molecules, which meet the requirements for use in ligand-binding assays and absorption, distribution, metabolism, and excretion studies. Copyright © 2017 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.
Pharmaceutical policy and the lay public
DEFF Research Database (Denmark)
Traulsen, Janine Marie; Almarsdóttir, Anna Birna
2005-01-01
Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisati......Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient...... organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry....... The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation...
Evaluating the impact of Brexit on the pharmaceutical industry.
Kazzazi, Fawz; Pollard, Cleo; Tern, Paul; Ayuso-Garcia, Alejandro; Gillespie, Jack; Thomsen, Inesa
2017-01-01
The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry.
Myrrh a traditional medicine or a multipurpose pharmaceutical excipient
Directory of Open Access Journals (Sweden)
Fatemeh Erfanfar
2015-12-01
Full Text Available A drug dosage form contains excipients as well as active pharmaceutical ingredients. Formerly, excipients were considered inert components that were used by a formulator to provide the suitable volume, weight and consistency of a dosage form. Today, however, excipients are expected to perform multifunctional roles such as enhancing physical, chemical and microbial stabilities of the dosage form, improving the color or odor of the formulation, and influencing the release and bioavailability of the active ingredient. Among various excipients, natural ones seem to be more beneficial to use, since they are economical, safe, biodegradable, and biocompatible. In this article, myrrh oleo-gum-resin is introduced as a potential natural multipurpose excipient that can perform many useful roles in pharmaceutical dosage forms. Scopus and Google scholar electronic databases were searched to find different properties of myrrh as an excipient. Moreover, ten famous traditional Iranian medicine books were studied to find semisolid formulations named Sabgh, which contained myrrh. One of these formulations was prepared, and its physical and microbiological stabilities were assessed. The role of myrrh as an excipient in this formulation is discussed here. Antibacterial and preservative effects shown in the formulation were related to the essential oil of myrrh. The gum portion was found to be a potential surfactant. In addition, myrrh is a natural muco-adhesive and film forming material. These properties were observed for myrrh in the Sabgh formulation in this study as well. So we can conclude that myrrh could be a potential multipurpose excipient in pharmaceutical industries, which needs further research.
Pharmaceutical care in the Netherlands. History, definition and projects
van Mil, J.W F
1996-01-01
The evolving concept of Pharmaceutical Care knows different interpretations in a different countries. In the Netherlands community pharmacists already perform several functions which may be part of the Pharmaceutical Care concept. The Dutch concept of Pharmaceutical care is tested in the TOM and
Pharmaceutical new product development: the increasing role of in-licensing.
Edwards, Nancy V
2008-12-01
Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.
Faltus, Timo; Brehm, Walter
2016-01-01
Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.
Supercritical fluid technology: concepts and pharmaceutical applications.
Deshpande, Praful Balavant; Kumar, G Aravind; Kumar, Averineni Ranjith; Shavi, Gopal Venkatesh; Karthik, Arumugam; Reddy, Meka Sreenivasa; Udupa, Nayanabhirama
2011-01-01
In light of environmental apprehension, supercritical fluid technology (SFT) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Supercritical fluid extraction using carbon dioxide (CO(2)) has been recognized as a green technology. It is a clean and versatile solvent with gas-like diffusivity and liquid-like density in the supercritical phase, which has provided an excellent alternative to the use of chemical solvents. The present commentary provides an overview of different techniques using supercritical fluids and their future opportunity for the drug delivery industry. Some of the emerging applications of SFT in pharmaceuticals, such as particle design, drug solubilization, inclusion complex, polymer impregnation, polymorphism, drug extraction process, and analysis, are also covered in this review. The data collection methods are based on the recent literature related to drug delivery systems using SFT platforms. SFT has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This cutting-edge technology is growing predominantly to surrogate conventional unit operations in relevance to the pharmaceutical production process. Supercritical fluid technology has recently drawn attention in the field of pharmaceuticals. It is a distinct conception that utilizes the solvent properties of supercritical fluids above their critical temperature and pressure, where they exhibit both liquid-like and gas-like properties, which can enable many pharmaceutical applications. For example, the liquid-like properties provide benefits in extraction processes of organic solvents or impurities, drug solubilization, and polymer plasticization, and the gas-like features facilitate mass transfer processes. It has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This review is
GC Method Validation for the Analysis of Menthol in Suppository Pharmaceutical Dosage Form
Directory of Open Access Journals (Sweden)
Murad N. Abualhasan
2017-01-01
Full Text Available Menthol is widely used as a fragrance and flavor in the food and cosmetic industries. It is also used in the medical and pharmaceutical fields for its various biological effects. Gas chromatography (GC is considered to be a sensitive method for the analysis of menthol. GC chromatographic separation was developed using capillary column (VF-624 and a flame ionization detector (FID. The method was validated as per ICH guidelines for various parameters such as precision, linearity, accuracy, solution stability, robustness, limit of detection, and quantification. The tested validation parameters were found to be within acceptable limits. The method was successfully applied for the quantification of menthol in suppositories formulations. Quality control departments and official pharmacopeias can use our developed method in the analysis of menthol in pharmaceutical dosage formulation and raw material.
Internet pharmaceutical sales: attributes, concerns, and future forecast.
Bruckel, Katy; Capozzoli, Ernest A
2003-01-01
Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters.
Kandpal, Lalit Mohan; Tewari, Jagdish; Gopinathan, Nishanth; Stolee, Jessica; Strong, Rick; Boulas, Pierre; Cho, Byoung-Kwan
2017-09-01
Determination of the content uniformity, assessed by the amount of an active pharmaceutical ingredient (API), and hardness of pharmaceutical materials is important for achieving a high-quality formulation and to ensure the intended therapeutic effects of the end-product. In this work, Fourier transform near infrared (FT-NIR) spectroscopy was used to determine the content uniformity and hardness of a pharmaceutical mini-tablet and standard tablet samples. Tablet samples were scanned using an FT-NIR instrument and tablet spectra were collected at wavelengths of 1000-2500 nm. Furthermore, multivariate analysis was applied to extract the relationship between the FT-NIR spectra and the measured parameters. The results of FT-NIR spectroscopy for API and hardness prediction were as precise as the reference high-performance liquid chromatography and mechanical hardness tests. For the prediction of mini-tablet API content, the highest coefficient of determination for the prediction (R2p) was found to be 0.99 with a standard error of prediction (SEP) of 0.72 mg. Moreover, the standard tablet hardness measurement had a R2p value of 0.91 with an SEP of 0.25 kg. These results suggest that FT-NIR spectroscopy is an alternative and accurate nondestructive measurement tool for the detection of the chemical and physical properties of pharmaceutical samples.
The ethics of the medical-pharmaceutical relationship.
Vashi, Neelam A; Latkowski, Jo-Ann M
2012-01-01
Physician interaction with the pharmaceutical industry raises many ethical concerns. This relationship is complex, owing to a pluralism of beliefs held by physicians, patients, and third parties. As a result, determining whether physicians fulfill their responsibilities to both the professional and public communities is an arduous endeavor. In an effort to clarify the situation and provide transparency to this complex relationship, medical and pharmaceutical organizations have enacted their own respective codes and guidelines. Even with adherence to these guidelines, questions remain regarding the codependent relationship that interweaves the pharmaceutical industry with the medical community. Owing to the ever-changing landscape enmeshing product development, scientific advancement, corporate realities and patient care, the proper choice for physicians is rarely obvious; however, to operate to the highest standards, those in the medical community must be candid about relations with the pharmaceutical industry and transparent in their financial interests. Further undertakings should focus not on the eradication of physician-pharmaceutical interaction, but instead on the education of physicians about industry marketing strategies and the delineation of boundaries of these interactions to benefit not the individual physician, but our patients. Copyright © 2012. Published by Elsevier Inc.
Cervera-Padrell, Albert E; Skovby, Tommy; Kiil, Søren; Gani, Rafiqul; Gernaey, Krist V
2012-10-01
A systematic framework is proposed for the design of continuous pharmaceutical manufacturing processes. Specifically, the design framework focuses on organic chemistry based, active pharmaceutical ingredient (API) synthetic processes, but could potentially be extended to biocatalytic and fermentation-based products. The method exploits the synergic combination of continuous flow technologies (e.g., microfluidic techniques) and process systems engineering (PSE) methods and tools for faster process design and increased process understanding throughout the whole drug product and process development cycle. The design framework structures the many different and challenging design problems (e.g., solvent selection, reactor design, and design of separation and purification operations), driving the user from the initial drug discovery steps--where process knowledge is very limited--toward the detailed design and analysis. Examples from the literature of PSE methods and tools applied to pharmaceutical process design and novel pharmaceutical production technologies are provided along the text, assisting in the accumulation and interpretation of process knowledge. Different criteria are suggested for the selection of batch and continuous processes so that the whole design results in low capital and operational costs as well as low environmental footprint. The design framework has been applied to the retrofit of an existing batch-wise process used by H. Lundbeck A/S to produce an API: zuclopenthixol. Some of its batch operations were successfully converted into continuous mode, obtaining higher yields that allowed a significant simplification of the whole process. The material and environmental footprint of the process--evaluated through the process mass intensity index, that is, kg of material used per kg of product--was reduced to half of its initial value, with potential for further reduction. The case-study includes reaction steps typically used by the pharmaceutical
Pharmaceutical care in smoking cessation
Directory of Open Access Journals (Sweden)
Marín Armero A
2015-01-01
Full Text Available Alicia Marín Armero,1 Miguel A Calleja Hernandez,2 Sabina Perez-Vicente,3 Fernando Martinez-Martinez4 1Community Pharmacy, Murcia, Spain; 2Hospital Pharmacy, University Hospital Virgen de las Nieves, Granada, Spain; 3Result Evaluation Unit, Institute of Biomedicine, Sevilla, Spain; 4Research Unit in Pharmaceutical Care, University of Granada, Granada, Spain Abstract: As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. Keywords: community pharmacy, health campaign, tobacco cessation, nicotine replacement therapy
Synthetic biology advances for pharmaceutical production
Breitling, Rainer; Takano, Eriko
2015-01-01
Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems.
Pricing and Reimbursement in U.S. Pharmaceutical Markets
Newhouse, Joseph Paul; Berndt, Ernst R.
2010-01-01
In this survey chapter on pricing and reimbursement in U.S. pharmaceutical markets, we first provide background information on important federal legislation, institutional details regarding distribution channel logistics, definitions of alternative price measures, related historical developments, and reasons why price discrimination is highly prevalent among branded pharmaceuticals. We then present a theoretical framework for the pricing of branded pharmaceuticals, without and then in the pre...
Assessing the assessments: Pharmaceuticals in the environment
International Nuclear Information System (INIS)
Enick, O.V.; Moore, M.M.
2007-01-01
The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development
42 CFR 416.48 - Condition for coverage-Pharmaceutical services.
2010-10-01
... 42 Public Health 3 2010-10-01 2010-10-01 false Condition for coverage-Pharmaceutical services. 416... Coverage § 416.48 Condition for coverage—Pharmaceutical services. The ASC must provide drugs and... direction of an individual designated responsible for pharmaceutical services. (a) Standard: Administration...
Value of pharmaceuticals: ensuring the future of research and development.
Serajuddin, Hamida K; Serajuddin, Abu T M
2006-01-01
To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after
Nozal, Raúl Rodríquez
2011-01-01
The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'.
Case histories in pharmaceutical risk management.
McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E
2009-12-01
The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).
Pharmaceutical care in smoking cessation.
Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando
2015-01-01
As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.
Cost-containment as part of pharmaceutical policy
DEFF Research Database (Denmark)
Almarsdóttir, Anna Birna; Traulsen, Janine Marie
2005-01-01
and profit controls; 2) reimbursement system charges; 3) other fiscal measures; 4) quality measures. Pharmaceuticals policy has suffered from the pervasive misunderstanding that drugs are like any other commodity; resulting in policy makers viewing pharmaceuticals expenditures without thinking about drugs...
Information sources and utilization patterns of pharmaceutical ...
African Journals Online (AJOL)
The study investigated the adequacy of pharmaceutical scientists' information environment in feeding their occupational activities. Data was collected through observation and through questionnaire administration to all the twenty-seven scientists in two large pharmaceutical companies in Lagos, Nigeria. Findings revealed ...
Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune
2010-06-01
This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.
Rational Use of Medicines in Relation to Pharmaceutical Supply ...
African Journals Online (AJOL)
Pharmaceutical management involves a set of practices aiming at ensuring timely availability and appropriate use of safe, effective and quality pharmaceuticals and services in any health care setting. Rational use of medicines is often associated with efficiency of pharmaceutical supply system that operates in the health ...
Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters
Directory of Open Access Journals (Sweden)
Matthias de Cazes
2014-10-01
Full Text Available The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds.
Prioritizing veterinary pharmaceuticals for aquatic environment in Korea.
Kim, Younghee; Jung, Jinyong; Kim, Myunghyun; Park, Jeongim; Boxall, Alistair B A; Choi, Kyungho
2008-09-01
Pharmaceutical residues may have serious impacts on nontarget biological organisms in aquatic ecosystems, and have therefore precipitated numerous investigations worldwide. Many pharmaceutical compounds available on the market need to be prioritized based on their potential ecological and human health risks in order to develop sound management decisions. We prioritized veterinary pharmaceuticals in Korea by their usage, potential to enter the environment, and toxicological hazard. Twenty compounds were identified in the top priority class, most of which were antibiotics. Among these compounds, 8 were identified as deserving more immediate attention: amoxicillin, enramycin, fenbendazole, florfenicol, ivermectin, oxytetracycline, tylosin, and virginiamycin. A limitation of this study is that we initially screened veterinary pharmaceuticals by sales tonnage for veterinary use only. However, this is the first attempt to prioritize veterinary pharmaceuticals in Korea, and it provides important concepts for developing environmental risk management plans for such contaminants in aquatic systems. Copyright © 2008 Elsevier B.V. All rights reserved.
Ozonation for degradation of pharmaceutical in hospital wastewater
DEFF Research Database (Denmark)
Bester, Kai; Hansen, Kamilla S; Spiliotopoulou, Aikaterini
-pollutants (Antoniou et al., 2013). In the present work, ozonation of biological treated hospital wastewater spiked with pharmaceuticals were performed to determine the required ozone dose for 90 % removal of the investigated pharmaceuticals. Effluents with different DOC level were used to investigate the effect...... of DOC on the removal of the pharmaceuticals. Furthermore, the effect of pH on ozone decomposition was investigated in relevant pH range....
The behaviour of pharmaceuticals in anaerobic digester sludge
Campbell, Alison
2013-01-01
Pharmaceuticals are biologically active compounds that may be consumed in hundreds of tonnes per year, and which are excreted into municipal sewerage systems. Many pharmaceuticals persist during sewage treatment, and significant environmental risk has been linked to incomplete removal of pharmaceuticals. Evaluation of this risk is important and should be as representative as possible, taking into consideration all significant exposure routes and removal processes. Sludge treatment processes a...
Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil
International Nuclear Information System (INIS)
Li, W.C.
2014-01-01
With the rapid economic development, a better living condition leads to longer life expectancy, which increased the total population, in particular the elderly group. It may result in increase in the demand of pharmaceuticals for people in domestic use or in hospital. Although most sewage treatment plants or waste water treatment plantsmet the regulatory requirement, there are still many pharmaceuticals removed incompletely and thus discharged to the environment. Therefore, the pharmaceuticals residue draws the public concern because they might cause adverse effects on the organism even human beings. Recently, many studies have published on the source and occurrence as well as the fate of pharmaceuticals all over the world. This paper summarized and reviewed the recent studies on the sources, occurrence, fate and the effects of the most common pharmaceuticals. Finally, it gave the suggestion and risk management for controlling the pharmaceuticals. - Highlights: • The sources of pharmaceutical residuals are studied. • Occurrence and fate of pharmaceutical in environment are studied. • Risk management and recommendation are provided on pharmaceutical pollution. - Concentration of pharmaceuticals in the natural environment is lower than in effluent of sewage treatment plants in which carbamazepine is found frequently in soil and water body
Synthetic biology advances for pharmaceutical production
Breitling, Rainer; Takano, Eriko
2015-01-01
Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872
Microbial Evaluation of Some Non-sterile Pharmaceutical ...
African Journals Online (AJOL)
Purpose: To determine the type and incidence of predominant microorganisms in certain non-sterile pharmaceuticals immediately after collection and one year later. Methods: All pharmaceutical samples were subjected to the following examinations: total bacterial count and presence of microbial pathogens, using ...
NanoXCT: a novel technique to probe the internal architecture of pharmaceutical particles.
Wong, Jennifer; D'Sa, Dexter; Foley, Matthew; Chan, John Gar Yan; Chan, Hak-Kim
2014-11-01
To demonstrate the novel application of nano X-ray computed tomography (NanoXCT) for visualizing and quantifying the internal structures of pharmaceutical particles. An Xradia NanoXCT-100, which produces ultra high-resolution and non-destructive imaging that can be reconstructed in three-dimensions (3D), was used to characterize several pharmaceutical particles. Depending on the particle size of the sample, NanoXCT was operated in Zernike Phase Contrast (ZPC) mode using either: 1) large field of view (LFOV), which has a two-dimensional (2D) spatial resolution of 172 nm; or 2) high resolution (HRES) that has a resolution of 43.7 nm. Various pharmaceutical particles with different physicochemical properties were investigated, including raw (2-hydroxypropyl)-beta-cyclodextrin (HβCD), poly (lactic-co-glycolic) acid (PLGA) microparticles, and spray-dried particles that included smooth and nanomatrix bovine serum albumin (BSA), lipid-based carriers, and mannitol. Both raw HβCD and PLGA microparticles had a network of voids, whereas spray-dried smooth BSA and mannitol generally had a single void. Lipid-based carriers and nanomatrix BSA particles resulted in low quality images due to high noise-to-signal ratio. The quantitative capabilities of NanoXCT were also demonstrated where spray-dried mannitol was found to have an average void volume of 0.117 ± 0.247 μm(3) and average void-to-material percentage of 3.5%. The single PLGA particle had values of 1993 μm(3) and 59.3%, respectively. This study reports the first series of non-destructive 3D visualizations of inhalable pharmaceutical particles. Overall, NanoXCT presents a powerful tool to dissect and observe the interior of pharmaceutical particles, including those of a respirable size.
Review on Physicochemical, Chemical, and Biological Processes for Pharmaceutical Wastewater
Li, Zhenchen; Yang, Ping
2018-02-01
Due to the needs of human life and health, pharmaceutical industry has made great progress in recent years, but it has also brought about severe environmental problems. The presence of pharmaceuticals in natural waters which might pose potential harm to the ecosystems and humans raised increasing concern worldwide. Pharmaceuticals cannot be effectively removed by conventional wastewater treatment plants (WWTPs) owing to the complex composition, high concentration of organic contaminants, high salinity and biological toxicity of pharmaceutical wastewater. Therefore, the development of efficient methods is needed to improve the removal effect of pharmaceuticals. This review provides an overview on three types of treatment technologies including physicochemical, chemical and biological processes and their advantages and disadvantages respectively. In addition, the future perspectives of pharmaceutical wastewater treatment are given.
76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
2011-09-26
..., efficacy, and durability of response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea. FDA intends to make background material...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee link. Procedure...
Information flow in the pharmaceutical supply chain.
Yousefi, Nazila; Alibabaei, Ahmad
2015-01-01
Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.
Pharmaceutical marketing research and the prescribing physician.
Greene, Jeremy A
2007-05-15
Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.
Funding pharmaceutical innovation through direct tax credits.
Lybecker, Kristina M; Freeman, Robert A
2007-07-01
Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.
Microbiological testing of pharmaceuticals and cosmetics in Egypt.
Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan
2015-12-09
Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of bacterial contaminants. Forty-one bacterial contaminants were isolated from 31 of the tested preparations. These isolates were subjected to biochemical identification by both conventional tests as well as API kits, which were sufficient for the accurate identification of only 11 out of the 41 bacterial contaminants (26.8%) to the species level. The remaining isolates were inconclusively identified or showed contradictory results after using both biochemical methods. Using molecular methods, 24 isolates (58.5%) were successfully identified to the species level. Moreover, polymerase chain reaction (PCR) assays were compared to standard biochemical methods in the detection of pharmacopoeial bacterial indicators in artificially-contaminated pharmaceutical samples. PCR-based methods proved to be superior regarding speed, cost-effectiveness and sensitivity. Therefore, pharmaceutical manufacturers would be advised to adopt PCR-based methods in the microbiological quality testing of pharmaceuticals in the future.
Directory of Open Access Journals (Sweden)
Junmin Lai
2017-02-01
Full Text Available The aim of the study was to investigate the effects of the loading factors, i.e., the initial drug loading concentration and the ratio of the drug to carriers, on the in vitro pharmaceutical performance of drug-loaded mesoporous systems. Ibuprofen (IBU was used as a model drug, and two non-ordered mesoporous materials of commercial silica Syloid® 244FP (S244FP and Neusilin® US2 (NS2 were selected in the study. The IBU-loaded mesoporous samples were prepared by a solvent immersion method with a rotary evaporation drying technique and characterized by polarized light microscopy (PLM, Fourier transform infrared (FTIR spectroscopy, X-ray powder diffraction (XRPD and differential scanning calorimetry (DSC. Dissolution experiments were performed in simulated gastric media at 37 °C under non-sink conditions. The concentration of IBU in solution was determined by HPLC. The study showed that the dissolution rate of IBU can be improved significantly using the mesoporous S224FP carriers due to the conversion of crystalline IBU into the amorphous form. Both of the loading factors affected the IBU dissolution kinetics. Due to the molecular interaction between the IBU and NS2 carriers, the loading factors had little effects on the drug release kinetics with incomplete drug desorption recovery and insignificant dissolution enhancement. Care and extensive evaluation must therefore be taken when mesoporous materials are chosen as carrier delivery systems.
Global risk of pharmaceutical contamination from highly populated developing countries.
Rehman, Muhammad Saif Ur; Rashid, Naim; Ashfaq, Muhammad; Saif, Ameena; Ahmad, Nasir; Han, Jong-In
2015-11-01
Global pharmaceutical industry has relocated from the west to Asian countries to ensure competitive advantage. This industrial relocation has posed serious threats to the environment. The present study was carried out to assess the possible pharmaceutical contamination in the environment of emerging pharmaceutical manufacturing countries (Bangladesh, China, India and Pakistan). Although these countries have made tremendous progress in the pharmaceutical sector but most of their industrial units discharge wastewater into domestic sewage network without any treatment. The application of untreated wastewater (industrial and domestic) and biosolids (sewage sludge and manure) in agriculture causes the contamination of surface water, soil, groundwater, and the entire food web with pharmaceutical compounds (PCs), their metabolites and transformed products (TPs), and multidrug resistant microbes. This pharmaceutical contamination in Asian countries poses global risks via product export and international traveling. Several prospective research hypotheses including the development of new analytical methods to monitor these PCs/TPs and their metabolites, highly resistant microbial strains, and mixture toxicity as a consequence of pharmaceutical contamination in these emerging pharmaceutical exporters have also been proposed based on the available literature. Copyright © 2013 Elsevier Ltd. All rights reserved.
Annals of SAM meeting '96. National meeting on precious metals
International Nuclear Information System (INIS)
1996-01-01
Works are presented at the SAM meeting '96 of the Argentine Materials Association. The papers can be grouped under the following main topics: physical metallurgy; ceramics; polymers; precious metals; extractive metallurgy; corrosion; powder metallurgy. refs., ills
Microbiological testing of pharmaceuticals and cosmetics in Egypt
Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan
2015-01-01
Background Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Results Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of b...
FACTORS AFFECTING EMPLOYEE JOB SATISFACTION OF PHARMACEUTICAL SECTOR
Mosammod Mahamuda Parvin; M M Nurul Kabir
2011-01-01
The Pharmaceutical sector plays a vital role in underpinning the economic development of a country. This study attempts to evaluate job satisfaction of employees in different pharmaceutical companies. It focuses on the relative importance of job satisfaction factors and their impacts on the overall job satisfaction of employees. It also investigates the impacts of pharmaceutical type, work experience, age, and sex differences on the attitudes toward job Satisfaction. The result shows that sal...
Directory of Open Access Journals (Sweden)
Sayaka Saito
Full Text Available BACKGROUND: Previous surveys on the relationship between physicians and pharmaceutical representatives (PRs have been of limited quality. The purpose of our survey of practicing physicians in Japan was to assess the extent of their involvement in pharmaceutical promotional activities, physician characteristics that predict such involvement, attitudes toward relationships with PRs, correlations between the extent of involvement and attitudes, and differences in the extent of involvement according to self-reported prescribing behaviors. METHODS AND FINDINGS: From January to March 2008, we conducted a national survey of 2621 practicing physicians in seven specialties: internal medicine, general surgery, orthopedic surgery, pediatrics, obstetrics-gynecology, psychiatry, and ophthalmology. The response rate was 54%. Most physicians met with PRs (98%, received drug samples (85% and stationery (96%, and participated in industry-sponsored continuing medical education (CME events at the workplace (80% and outside the workplace (93%. Half accepted meals outside the workplace (49% and financial subsidies to attend CME events (49%. Rules at the workplace banning both meetings with PRs and gifts predicted less involvement of physicians in promotional activities. Physicians valued information from PRs. They believed that they were unlikely to be influenced by promotional activities, but that their colleagues were more susceptible to such influence than themselves. They were divided about the appropriateness of low-value gifts. The extent of physician involvement in promotional activities was positively correlated with the attitudes that PRs are a valuable source of information and that gifts are appropriate. The extent of such involvement was higher among physicians who prefer to ask PRs for information when a new medication becomes available, physicians who are not satisfied with patient encounters ending only with advice, and physicians who prefer to
Metrology in Pharmaceutical Industry - A Case Study
International Nuclear Information System (INIS)
Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.
2016-01-01
Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area. (paper)
Roggo, Y; Jent, N; Edmond, A; Chalus, P; Ulmschneider, M
2005-09-01
Near-infrared spectroscopy (NIRS) has become a widely used analytical technique in the pharmaceutical industry, serving for example to determine the active substance or water content of tablets. Its great advantage lies in the minimal sample preparation required and speed of measurement. In a study designed to detect the effects of process on tablet dissolution, we describe the application of NIRS to the detection and identification of changes in uncoated and coated tablets in response to pilot-scale changes in process parameters during melt granulation, compression, and coating. Beginning with a qualitative comparison between pharmaceutical batches, we show that NIRS and principal component analysis can separate batches produced with different melt granulation parameters and differentiate between cores compressed with different compaction forces. Complementary infrared imaging can also explain the difference in dissolution properties between samples produced with different melt granulation parameters. NIRS is sensitive to changes in coating formulation, the quality of a coating excipient (hydroxypropyl methylcellulose), and coating time. In a concluding quantitative analysis, we demonstrate the feasibility of NIRS in a manufacturing context for predicting coating time and detecting production cores failing to meet dissolution test specifications.
Pharmaceuticals as indictors of sewage-influenced groundwater
Müller, Beate; Scheytt, Traugott; Asbrand, Martin; de Casas, Andrea Mross
2012-09-01
A set of human pharmaceuticals enables identification of groundwater that is influenced by sewage and provides information on the time of recharge. As the consumption rates of the investigated pharmaceuticals have changed over time, so too has the composition of the sewage. At the study area, south of Berlin (Germany), irrigation was performed as a method of wastewater clean-up at sewage irrigation farms until the early 1990s. Today, treated wastewater is discharged into the surface-water-stream Nuthegraben. Groundwater and surface-water samples were analyzed for the pharmaceutical substances clofibric acid, bezafibrate, diclofenac, carbamazepine and primidone, the main ions and organic carbon. The pharmaceutical substances were detected at concentrations up to microgram-per-liter level in groundwater and surface-water samples from the Nuthegraben Lowland area and from the former irrigation farms. Concentrations detected in groundwater are generally much lower than in surface water and there is significant variation in the distribution of pharmaceutical concentrations in groundwater. Groundwater influenced by the irrigation of sewage water shows higher primidone and clofibric-acid concentrations. Groundwater influenced by recent discharge of treated sewage water into the surface water shows high carbamazepine concentrations while concentrations of primidone and clofibric acid are low.
Kockmann, Norbert; Gottsponer, Michael; Zimmermann, Bertin; Roberge, Dominique M
2008-01-01
Microstructured devices offer unique transport capabilities for rapid mixing, enhanced heat and mass transfer and can handle small amounts of dangerous or unstable materials. The integration of reaction kinetics into fluid dynamics and transport phenomena is essential for successful application from process design in laboratory to chemical production. Strategies to implement production campaigns up to tons of pharmaceutical chemicals are discussed, based on Lonza projects.
Tropical Journal of Pharmaceutical Research: About this journal
African Journals Online (AJOL)
Tropical Journal of Pharmaceutical Research: About this journal. Journal Home > Tropical Journal of Pharmaceutical Research: About this journal. Log in or Register to get access to full text downloads.
Nigerian Journal of Pharmaceutical Research: About this journal
African Journals Online (AJOL)
Nigerian Journal of Pharmaceutical Research: About this journal. Journal Home > Nigerian Journal of Pharmaceutical Research: About this journal. Log in or Register to get access to full text downloads.
Report of the Material Control and Material Accounting Task Force
International Nuclear Information System (INIS)
1978-03-01
In September 1977 a Task Force was formed to complete a study of the role of material control and material accounting in NRC's safeguards program. The Task Force's assignment was to: define the roles and objectives of material control and material accounting in the NRC safeguards program; recommend goals for the material control and material accounting systems based on their roles and objectives; assess the extent to which the existing safeguards regulatory base meets or provides the capability to meet the recommended goals; and provide direction for material control and material accounting development, including both near-term and long-term upgrades. The study was limited to domestic nuclear facilities possessing significant amounts of plutonium, uranium-233 or highly enriched uranium in unsealed form. The Task Force findings are reported
Faltus, Timo; Brehm, Walter
2016-01-01
Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States. PMID:27965965
[Participants-centered Design of Annual Meeting: From the Perspectives of Instructional Systems].
Suzuki, Katsuaki
2018-01-01
This paper examines the reform experience of the 10th Annual Meeting of the Japanese Society for Pharmaceutical Palliative Care and Sciences from Instructional Systems perspectives, to check whether it was effective, efficient, and appealing for participants. "Instructional Systems" has been a research area in educational technology for the past 50 years, and has also been applied to training and human resource development in healthcare domains. If an annual meeting is to be designed for participants' learning, then perspectives of Instructional Systems can be applied to interpret the effort of the reform. First, fill in the gaps of participants' knowledge, using before-and-after comparison. Design a conference to meet the needs of its participants by checking why they attend (expectations) and what they bring in (starting status). Second, design the conference as a process of innovation. The bigger the expected changes, the more carefully participants should be prepared to accommodate them. Third, follow plan-do-check-action cycles with data for confirming and revising the new ways of running the meeting. Plan to check "exportability" of the new ways, to assess whether it can be generalized to future meetings.
Directory of Open Access Journals (Sweden)
Patrick P. DeLuca
2010-09-01
Full Text Available Controlled release delivery is available for many routes of administration and offers many advantages (as microparticles and nanoparticles over immediate release delivery. These advantages include reduced dosing frequency, better therapeutic control, fewer side effects, and, consequently, these dosage forms are well accepted by patients. Advances in polymer material science, particle engineering design, manufacture, and nanotechnology have led the way to the introduction of several marketed controlled release products and several more are in pre-clinical and clinical development.
76th Annual Meeting | Annual Meetings | Events | Indian Academy of ...
Indian Academy of Sciences (India)
Structural materials for the future: The case of bulk metallic glasses ... Cell therapy for ocular surface: A successful model of regenerative medicine. 11.45. SHUBHA TOLE, Tata ... Business Meeting of Fellows (Seminar Hall). 17.30 - 18.00.
A practical discussion of risk management for manufacturing of pharmaceutical products.
Mollah, A Hamid; Baseman, Harold S; Long, Mike; Rathore, Anurag S
2014-01-01
Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing. Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these
Pharmacoligaclly Active: Clinical Trials and the Pharmaceuticals ...
African Journals Online (AJOL)
Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...
Pharmaceutical crystallography: is there a devil in the details?
DEFF Research Database (Denmark)
Bond, A. D.
2012-01-01
Modern instruments for small-molecule crystallography continue to become more sophisticated and more automated. This technical progress provides a basis for frontier research in chemical and pharmaceutical crystallography, but it also encourages analytical crystallographers to become more...... are presented for pharmaceutical compounds, and the potential importance of the "details" in pharmaceutical crystallography is discussed....
Effects of soil properties on the uptake of pharmaceuticals into earthworms
International Nuclear Information System (INIS)
Carter, Laura J.; Ryan, Jim J.; Boxall, Alistair B.A.
2016-01-01
Pharmaceuticals can enter the soil environment when animal slurries and sewage sludge are applied to land as a fertiliser or during irrigation with contaminated water. These pharmaceuticals may then be taken up by soil organisms possibly resulting in toxic effects and/or exposure of organisms higher up the food chain. This study investigated the influence of soil properties on the uptake and depuration of pharmaceuticals (carbamazepine, diclofenac, fluoxetine and orlistat) in the earthworm Eisenia fetida. The uptake and accumulation of pharmaceuticals into E. fetida changed depending on soil type. Orlistat exhibited the highest pore water based bioconcentration factors (BCFs) and displayed the largest differences between soil types with BCFs ranging between 30.5 and 115.9. For carbamazepine, diclofenac and fluoxetine BCFs ranged between 1.1 and 1.6, 7.0 and 69.6 and 14.1 and 20.4 respectively. Additional analysis demonstrated that in certain treatments the presence of these chemicals in the soil matrices changed the soil pH over time, with a statistically significant pH difference to control samples. The internal pH of E. fetida also changed as a result of incubation in pharmaceutically spiked soil, in comparison to the control earthworms. These results demonstrate that a combination of soil properties and pharmaceutical physico-chemical properties are important in terms of predicting pharmaceutical uptake in terrestrial systems and that pharmaceuticals can modify soil and internal earthworm chemistry which may hold wider implications for risk assessment. - Highlights: • Uptake of pharmaceuticals into earthworms is influenced by soil parameters. • Presence of pharmaceuticals in the terrestrial environment influences soil pH. • Uptake of pharmaceuticals by earthworms changes internal earthworm pH. - The uptake of pharmaceuticals into soil invertebrates is dependent on the complex interplay between pharmaceutical physico-chemical properties and soil
Mergers and innovation in the pharmaceutical industry.
Comanor, William S; Scherer, F M
2013-01-01
Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.
Nguyen, Trung T; Barber, Andrew R; Corbin, Kendall; Zhang, Wei
2017-01-01
The worldwide annual production of lobster was 165,367 tons valued over $3.32 billion in 2004, but this figure rose up to 304,000 tons in 2012. Over half the volume of the worldwide lobster production has been processed to meet the rising global demand in diversified lobster products. Lobster processing generates a large amount of by-products (heads, shells, livers, and eggs) which account for 50-70% of the starting material. Continued production of these lobster processing by-products (LPBs) without corresponding process development for efficient utilization has led to disposal issues associated with costs and pollutions. This review presents the promising opportunities to maximize the utilization of LPBs by economic recovery of their valuable components to produce high value-added products. More than 50,000 tons of LPBs are globally generated, which costs lobster processing companies upward of about $7.5 million/year for disposal. This not only presents financial and environmental burdens to the lobster processors but also wastes a valuable bioresource. LPBs are rich in a range of high-value compounds such as proteins, chitin, lipids, minerals, and pigments. Extracts recovered from LPBs have been demonstrated to possess several functionalities and bioactivities, which are useful for numerous applications in water treatment, agriculture, food, nutraceutical, pharmaceutical products, and biomedicine. Although LPBs have been studied for recovery of valuable components, utilization of these materials for the large-scale production is still very limited. Extraction of lobster components using microwave, ultrasonic, and supercritical fluid extraction were found to be promising techniques that could be used for large-scale production. LPBs are rich in high-value compounds that are currently being underutilized. These compounds can be extracted for being used as functional ingredients, nutraceuticals, and pharmaceuticals in a wide range of commercial applications
Financing pharmaceuticals in transition economies.
Kanavos, P
1999-06-01
This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.
New perspectives for visual characterization of pharmaceutical solids
DEFF Research Database (Denmark)
Laitinen, Niklas; Antikainen, Osmo; Rantanen, Jukka
2004-01-01
The utilization of descriptive image information in pharmaceutical powder technology is rather limited. Consequently, the development of this discipline is a challenge within physical characterization of pharmaceutical solids. The aim of this study was to develop and evaluate an inventive visual...... in particle size analysis also enabling the evaluation of the further product quality in the end of the granulation process. The idea of characterization of bulk surface images opens new perspectives for characterization of pharmaceutical solids....
2006 Fundamental Research Underlying Solid-State Lighting: Contractors Meeting
Energy Technology Data Exchange (ETDEWEB)
Fitzsimmons, Tim [Dept. of Energy (DOE), Washington, DC (United States). Office of Basic Energy Sciences. Division of Materials Sciences and Engineering; Kini, Arvind [Dept. of Energy (DOE), Washington, DC (United States). Office of Basic Energy Sciences. Division of Materials Sciences and Engineering; Kelley, Dick [Dept. of Energy (DOE), Washington, DC (United States). Office of Basic Energy Sciences. Division of Materials Sciences and Engineering
2006-02-01
This volume highlights the scientific content of the 2006 Fundamental Research Underlying Solid-State Lighting Contractors Meeting sponsored by the Division of Materials Sciences and Engineering (DMS&E) in the Office of Basic Energy Sciences (BES) of the U. S. Department of Energy (DOE). This meeting is the second in a series of research theme-based Contractors Meetings and will focus on BES/DMS&E-funded research that underpins solid-state lighting technology. The meeting will feature research that cuts across several DMS&E core research program areas. The major programmatic emphasis is on developing a fundamental scientific base, in terms of new concepts and new materials that could be used or mimicked in designing novel materials, processes or devices.
Assessing the Factors Associated With Iran's Intra-Industry Trade in Pharmaceuticals.
Yusefzadeh, Hassan; Hadian, Mohammad; Abolghasem Gorji, Hassan; Ghaderi, Hossein
2015-03-30
Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran's intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. This study assessed the factors associated with Iran's intra-industry trade in pharmaceuticals with the rest of the world during the 2001-2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran's pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran's IIT in pharmaceuticals. The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran's intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn't have the expected signs. In addition, we found that Iran's IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. In order to get more prepared for integration into the global economy, the development of Iran's IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade.
On radiation treatment of pharmaceutical products
International Nuclear Information System (INIS)
Zukov, V.; Mende, V.
1976-01-01
The progress made in the GDR over the past decade in the field of radiosterilization of products of the medical industry, has naturally raised the question of radiosterilization in pharmaceutics. However, because of the diversity and complicated nature of pharmaceutical products and, consequently, longer periods of time required for preliminary studies, their radiosterilization has not yet been applied on an industrial scale, in contrast to the situation in the medical industry. The studies carried out so far have been mainly concerned with ascertaining the permissibility and effectiveness of radiosterilization of individual products under particular conditions rather than with laying down a broad theoretical basis. Accordingly, the present paper does not describe results of special studies but presents a brief rewiev of some studies on radiation treatment of pharmaceutical products undertaken in the GDR. (author)
Material efficiency: providing material services with less material production.
Allwood, Julian M; Ashby, Michael F; Gutowski, Timothy G; Worrell, Ernst
2013-03-13
Material efficiency, as discussed in this Meeting Issue, entails the pursuit of the technical strategies, business models, consumer preferences and policy instruments that would lead to a substantial reduction in the production of high-volume energy-intensive materials required to deliver human well-being. This paper, which introduces a Discussion Meeting Issue on the topic of material efficiency, aims to give an overview of current thinking on the topic, spanning environmental, engineering, economics, sociology and policy issues. The motivations for material efficiency include reducing energy demand, reducing the emissions and other environmental impacts of industry, and increasing national resource security. There are many technical strategies that might bring it about, and these could mainly be implemented today if preferred by customers or producers. However, current economic structures favour the substitution of material for labour, and consumer preferences for material consumption appear to continue even beyond the point at which increased consumption provides any increase in well-being. Therefore, policy will be required to stimulate material efficiency. A theoretically ideal policy measure, such as a carbon price, would internalize the externality of emissions associated with material production, and thus motivate change directly. However, implementation of such a measure has proved elusive, and instead the adjustment of existing government purchasing policies or existing regulations-- for instance to do with building design, planning or vehicle standards--is likely to have a more immediate effect.