Bioequivalence and Statistics in Clinical Pharmacology: Edition 2

Scott D. Patterson · Byron Jones

mar. 2017 · CRC Press

Rafbók

460

Síður

Gjaldgeng

Um þessa rafbók

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples.

Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials.

This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials.

Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Um höfundinn

Scott D. Patterson, Byron Jones

Gefa þessari rafbók einkunn.

Segðu okkur hvað þér finnst.

Upplýsingar um lestur

Snjallsímar og spjaldtölvur

Settu upp forritið Google Play Books fyrir Android og iPad/iPhone. Það samstillist sjálfkrafa við reikninginn þinn og gerir þér kleift að lesa með eða án nettengingar hvar sem þú ert.

Fartölvur og tölvur

Hægt er að hlusta á hljóðbækur sem keyptar eru í Google Play í vafranum í tölvunni.

Lesbretti og önnur tæki

Til að lesa af lesbrettum eins og Kobo-lesbrettum þarftu að hlaða niður skrá og flytja hana yfir í tækið þitt. Fylgdu nákvæmum leiðbeiningum hjálparmiðstöðvar til að flytja skrár yfir í studd lesbretti.