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Author : Victor F. Smolen
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 288 pages
Book Rating : 4.3/5 (91 download)
Download or read book Bioavailability Methodology and Regulation written by Victor F. Smolen and published by Wiley-Interscience. This book was released on 1984 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Victor F. Smolen
Publisher :
ISBN 13 :
Total Pages : 259 pages
Book Rating : 4.:/5 (83 download)
Download or read book Controlled Drug Bioavailability written by Victor F. Smolen and published by . This book was released on 1984 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309086256
Total Pages : 433 pages
Book Rating : 4.3/5 (9 download)
Download or read book Bioavailability of Contaminants in Soils and Sediments written by National Research Council and published by National Academies Press. This book was released on 2003-05-03 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioavailability refers to the extent to which humans and ecological receptors are exposed to contaminants in soil or sediment. The concept of bioavailability has recently piqued the interest of the hazardous waste industry as an important consideration in deciding how much waste to clean up. The rationale is that if contaminants in soil and sediment are not bioavailable, then more contaminant mass can be left in place without creating additional risk. A new NRC report notes that the potential for the consideration of bioavailability to influence decision-making is greatest where certain chemical, environmental, and regulatory factors align. The current use of bioavailability in risk assessment and hazardous waste cleanup regulations is demystified, and acceptable tools and models for bioavailability assessment are discussed and ranked according to seven criteria. Finally, the intimate link between bioavailability and bioremediation is explored. The report concludes with suggestions for moving bioavailability forward in the regulatory arena for both soil and sediment cleanup.
Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1420011677
Total Pages : 758 pages
Book Rating : 4.4/5 (2 download)
Download or read book Design and Analysis of Bioavailability and Bioequivalence Studies written by Shein-Chung Chow and published by CRC Press. This book was released on 2008-10-15 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
Author : Jose Julio Ortega-Calvo
Publisher : Springer Nature
ISBN 13 : 3030579190
Total Pages : 428 pages
Book Rating : 4.0/5 (35 download)
Download or read book Bioavailability of Organic Chemicals in Soil and Sediment written by Jose Julio Ortega-Calvo and published by Springer Nature. This book was released on 2020-10-15 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses bioavailability concepts and methods, summarizing the current knowledge on bioavailability science, as well as possible pathways for integrating bioavailability into risk assessment and the regulation of organic chemicals. Divided into 5 parts, it begins with an overview of chemical distribution in soil and sediment, as well as the bioavailability and bioaccumulation of chemicals in plants, soil, invertebrates and vertebrates (including humans). It then focuses on the impact of sorption processes and reviews bioavailability measurement methods. The closing chapters discuss the impact of bioavailability studies on chemical risk assessment, and highlights further research needs. Written by a multi-disciplinary team of authors, it is an essential resource for scientists in academia and industry, students, as well as for authorities.
Author : Vinod P. Shah
Publisher : Springer
ISBN 13 : 1493912895
Total Pages : 393 pages
Book Rating : 4.4/5 (939 download)
Download or read book Topical Drug Bioavailability, Bioequivalence, and Penetration written by Vinod P. Shah and published by Springer. This book was released on 2015-01-30 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.
Author : Dieter Hauschke
Publisher : John Wiley & Sons
ISBN 13 : 0470094761
Total Pages : 328 pages
Book Rating : 4.4/5 (7 download)
Download or read book Bioequivalence Studies in Drug Development written by Dieter Hauschke and published by John Wiley & Sons. This book was released on 2007-03-13 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.
Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 9781420002027
Total Pages : 606 pages
Book Rating : 4.0/5 (2 download)
Download or read book Design and Analysis of Bioavailability and Bioequivalence Studies written by Shein-Chung Chow and published by CRC Press. This book was released on 1999-11-24 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."
Author : Han van de Waterbeemd
Publisher : John Wiley & Sons
ISBN 13 : 3527605150
Total Pages : 602 pages
Book Rating : 4.5/5 (276 download)
Download or read book Drug Bioavailability written by Han van de Waterbeemd and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: The peroral application (swallowing) of a medicine means that the body must first resorb the active substance before it can begin to take effect. The efficacy of drug uptake depends on the one hand on the chemical characteristics of the active substance, above all on its solubility and membrane permeability. On the other hand, it is determined by the organism's ability to absorb pharmaceuticals by way of specific transport proteins or to excrete them. Since many pharmacologically active substances are poorly suited for oral intake, a decisive criterion for the efficacy of a medicine is its so-called bioavailability. Written by an international team from academia and the pharmaceutical industry, this book covers all aspects of the oral bioavailability of medicines. The focus is placed on methods for determining the parameters relevant to bioavailability. These range from modern physicochemical techniques via biological studies in vitro and in vivo right up to computer-aided predictions. The authors specifically address possibilities for optimizing bioavailability during the early screening stage for the active substance. Its clear structure and comprehensive coverage make this book equally suitable for researchers and lecturers in industry and teaching.
Author : Lawrence X. Yu
Publisher : Springer
ISBN 13 : 1493912526
Total Pages : 472 pages
Book Rating : 4.4/5 (939 download)
Download or read book FDA Bioequivalence Standards written by Lawrence X. Yu and published by Springer. This book was released on 2014-09-05 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Author : Isadore Kanfer
Publisher : CRC Press
ISBN 13 : 1420020021
Total Pages : 334 pages
Book Rating : 4.4/5 (2 download)
Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2016-04-19 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica
Author : Isadore Kanfer
Publisher : CRC Press
ISBN 13 : 1420020013
Total Pages : 287 pages
Book Rating : 4.4/5 (2 download)
Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2007-11-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp
Author : Hamed Mahmmoud Abdou
Publisher : Mack Publishing Company
ISBN 13 :
Total Pages : 594 pages
Book Rating : 4.3/5 (91 download)
Download or read book Dissolution, Bioavailability & Bioequivalence written by Hamed Mahmmoud Abdou and published by Mack Publishing Company. This book was released on 1989 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: 1. Evolution of dissolution testing 5; 2. Theory of dissolution 11; 3. Theoretical concepts for the release of a drug from dosage forms 37; 4. Effect of the physicochemical properties of the drug on dissolution rate 53; 5. Factors affecting the rate of dissolution of solid dosage forms 73; 6. Effects of storage and packaging on the dissolution of drug formulations 107; 7. Factors relating to the dissolution apparatus 115; 8. Effect of the test parameters on dissolution rate 145; 9. Dissolution of suspensions 173; 10. Dissolution of topical dosage forms (creams, gels, and ointments) 189; 11. Dissolutions of suppositories 205; 12. Dissolution characteristics of controlled-release systems 215; 13. Methods for enhancement of the drug-dissolution characteristics 265; 14. Developing a new dissolution method 285; 15. Bioavailability, definitions and historical perspective 297; 17. In vitro modeling for drug absorption 315; 18. Pharmacokinetic considerations in bioavailability studies 335; 19. Bioavailability and variations in drug blood levels 367; 20. Bioavailability and the biologic response 385; 21. Measurements of bioavailability 399; 22. General issues to be considered in conducting bioavailability studies 415; 23. Bioavailability of controlled-release dosage forms 425; 24. In vivo release and bioavailability of topical preparations 437; 25. Methods for enhancement of bioavailability 455; 26. Bioequivalence: general definitions 477; 27. Bioequivalence: case histories 481; 28. Correlation of in vitro rate of dissolution with in vivo bioavailability 491; 29. Determination of bioequivalence and its regulatory aspects 517; 30. The official bioequivalence protocols and therapeutic equivalence 533.
Author : Adrian Kilcoyne
Publisher : OUP Oxford
ISBN 13 : 0191510394
Total Pages : 473 pages
Book Rating : 4.1/5 (915 download)
Download or read book Pharmaceutical Medicine written by Adrian Kilcoyne and published by OUP Oxford. This book was released on 2013-05-23 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Author : Alfred N. Martin
Publisher :
ISBN 13 :
Total Pages : 560 pages
Book Rating : 4.3/5 (91 download)
Download or read book Industrial Bioavailability and Pharmacokinetics written by Alfred N. Martin and published by . This book was released on 1977 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Isadore Kanfer
Publisher : Springer
ISBN 13 : 3319680781
Total Pages : 348 pages
Book Rating : 4.3/5 (196 download)
Download or read book Bioequivalence Requirements in Various Global Jurisdictions written by Isadore Kanfer and published by Springer. This book was released on 2017-12-05 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
Author :
Publisher :
ISBN 13 :
Total Pages : 1072 pages
Book Rating : 4.3/5 (91 download)
Download or read book Code of Federal Regulations written by and published by . This book was released on 1994 with total page 1072 pages. Available in PDF, EPUB and Kindle. Book excerpt: Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
