The Handbook of Bioequivalence Testing is a practical treatise for all who are involved in
planning and conducting such studies. The roots to this book go back to the late 1970s when I
wrote The Textbook of Biopharmaceutics and Clinical Pharmacokinetics, the first book on the subject.
Several good books followed this teaching textbook, and I felt no compelling reason, despite the
suggestions of my publishers, to write another book on the subject. Almost 30 years later, I find
that there is a need to take a comprehensive approach to testing bioequivalence of drug
products. The Food and Drug Administration has undergone major changes in its thinking on
new suggestions to do these studies, and I find it exciting to design challenging studies. Generic
companies generally do not want to go against established norms, and there are good reasons
for that; however, the new Food and Drug Administration is ready to listen to alternate
methods and even petition to waive these studies. I believe once a company fully understands
the nature of the drug being developed, it will be possible to create tests that would qualify as
alternates to any biological testing. It is for this reason that I have included several classical
teaching chapters in this book.
planning and conducting such studies. The roots to this book go back to the late 1970s when I
wrote The Textbook of Biopharmaceutics and Clinical Pharmacokinetics, the first book on the subject.
Several good books followed this teaching textbook, and I felt no compelling reason, despite the
suggestions of my publishers, to write another book on the subject. Almost 30 years later, I find
that there is a need to take a comprehensive approach to testing bioequivalence of drug
products. The Food and Drug Administration has undergone major changes in its thinking on
new suggestions to do these studies, and I find it exciting to design challenging studies. Generic
companies generally do not want to go against established norms, and there are good reasons
for that; however, the new Food and Drug Administration is ready to listen to alternate
methods and even petition to waive these studies. I believe once a company fully understands
the nature of the drug being developed, it will be possible to create tests that would qualify as
alternates to any biological testing. It is for this reason that I have included several classical
teaching chapters in this book.
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