ABSTRACT

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology explores statistics used in day-to-day clinical pharmacology work. The book 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 demonstrat

chapter 1|16 pages

Drug Development and Clinical Pharmacology

chapter 2|22 pages

History and Regulation of Bioequivalence

chapter 3|40 pages

Testing for Average Bioequivalence

chapter 4|54 pages

BE Studies with More Than Two Periods

chapter 5|44 pages

Dealing with Unexpected BE Challenges

chapter 6|12 pages

The Future and Recent Past of BE Testing

chapter 7|54 pages

Clinical Pharmacology Safety Studies

chapter 8|26 pages

QTc

chapter 9|30 pages

Clinical Pharmacology Efficacy Studies

chapter 10|34 pages

Population Pharmacokinetics

chapter 11|2 pages

Epilogue