Topical Drug Bioavailability, Bioequivalence, and Penetration, Vinod P. Shah; Howard I. Maibach; John Jenner
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.
Описание: This truly comprehensive reference, in a mini-series format with five volumes, offers a detailed description of both well-known and recently introduced methods for percutaneous penetration enhancement.
Автор: Peter Sigmund Название: Particle Penetration and Radiation Effects Volume 2 ISBN: 3319352512 ISBN-13(EAN): 9783319352510 Издательство: Springer Рейтинг: Цена: 20896.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book represents volume 2 of a 3-volume monograph on Particle Penetration and Radiation Effects.
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.
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