Design and Analysis of Bioavailability and Bioequivalence Studies, Chow, Shein-Chung
Автор: Vinod P. Shah; Howard I. Maibach; John Jenner Название: Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 1493938568 ISBN-13(EAN): 9781493938568 Издательство: Springer Рейтинг: Цена: 18284.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.
Автор: Niazi Sarfaraz K Название: Handbook Of Bioequivalence Testing ISBN: 0849303958 ISBN-13(EAN): 9780849303951 Издательство: Taylor&Francis Цена: 22968.00 р. Наличие на складе: Поставка под заказ.
Описание: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.
Название: Generic drug product development ISBN: 036738437X ISBN-13(EAN): 9780367384371 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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 therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.
Описание: This book casts new light on the field of oral drug absorption. It outlines both the concept of the past and the novel concept of Finite Absorption Time (FAT). In addition, the authors explore the correlated need for re-definition of bioavailability, bioequivalence providing a plethora of experimental data. Accordingly, this book is intended for academics/students or scientists working in pharmaceutical industries, regulatory agencies, and contract research organizations. It can be used for teaching purposes in under- and post-graduate courses dealing with biopharmaceutics, pharmacokinetics and biomedical engineering.
Автор: Patterson Название: Bioequivalence and Statistics in Clinical Pharmacology ISBN: 1584885300 ISBN-13(EAN): 9781584885306 Издательство: Taylor&Francis Рейтинг: Цена: 13168.00 р. Наличие на складе: Поставка под заказ.
Описание: Bioequivalence and Statistics in Clinical Pharmacology covers the applications and basic elements of the theory of statistical methods in clinical pharmacology. It establishes techniques used in the assessment of bioequivalence and describes the use of statistics in clinical pharmacology studies of safety, ECG monitoring, efficacy, and population pharmacokinetics. The authors demonstrate study design, analysis, and interpretation of data using real data examples. The book emphasizes regulatory applications related to drug development and features a wide range of datasets as well as SAS and SPLUS code available on the Internet.
Автор: Vinod P. Shah; Howard I. Maibach; John Jenner Название: Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 1493912887 ISBN-13(EAN): 9781493912889 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.
Автор: Hauss, David J. Название: Oral Lipid-Based Formulations ISBN: 0824729455 ISBN-13(EAN): 9780824729455 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Поставка под заказ.
ООО "Логосфера " Тел:+7(495) 980-12-10 www.logobook.ru
