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Author : Victor F. Smolen
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 288 pages
Book Rating : 4.19/5 ( 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 : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309086256
Total Pages : 433 pages
Book Rating : 4.57/5 ( 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 : 4.78/5 ( 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 : Dieter Hauschke
Publisher : John Wiley & Sons
ISBN 13 : 0470094761
Total Pages : 328 pages
Book Rating : 4.61/5 ( 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 : Han van de Waterbeemd
Publisher : John Wiley & Sons
ISBN 13 : 3527605150
Total Pages : 602 pages
Book Rating : 4.56/5 ( 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 : Jose Julio Ortega-Calvo
Publisher : Springer Nature
ISBN 13 : 3030579190
Total Pages : 428 pages
Book Rating : 4.97/5 ( 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 : 4.96/5 ( 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 : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 9781420002027
Total Pages : 606 pages
Book Rating : 4.23/5 ( 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 : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309168961
Total Pages : 432 pages
Book Rating : 4.60/5 ( 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 2003-04-03 with total page 432 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 : Wiley-Interscience
ISBN 13 :
Total Pages : 680 pages
Book Rating : 4.16/5 ( download)
Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by Wiley-Interscience. This book was released on 1998-06-23 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.
