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: 153120.00 T
Наличие на складе: Нет в наличии.
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.

Автор: Patterson
Название: Bioequivalence and Statistics in Clinical Pharmacology
ISBN: 1584885300 ISBN-13(EAN): 9781584885306
Издательство: Taylor&Francis
Рейтинг:
Цена: 87790.00 T
Наличие на складе: Нет в наличии.
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.