Handbook of Bioequivalence Testing, 2nd Edition.
Handbook of Bioequivalence Testing, 2nd Edition
Sarfaraz K. Niazi
Drugs and the Pharmaceutical Sciences
Niazi, an author, patent law practitioner, and inventor who heads an organization that develops and manufactures biosimilar recombinant drugs, presents a handbook that details aspects of bioequivalence testing, including the physicochemical basis; drug delivery factors; pharmacokinetic/pharmacodynamic modeling; the rationale and principles; bioequivalence waivers; statistical evaluation; the regulatory inspection process; food effect bioequivalence studies; testing of topical drugs and nasal products; the US, European, and international perspectives on testing; protocols; documentation; laboratory and clinical practice; and method, computer, and software validation. This edition has been updated to include new findings in drug delivery and dosage form design and revised worldwide regulatory requirements, as well as new topics like the history of generic pharmaceuticals, new guidelines for submissions related to bioequivalency studies, models of noninferiority, the biosimilarity of large molecule drugs, the bioequivalence of complementary and alternative medicines, biosimilar therapeutic proteins and monoclonal antibodies, new FDA guidelines for bioanalytical method validation, outsourcing and monitoring bioequivalence studies, and the future of the field. ([umlaut] Ringgold, Inc., Portland, OR)