Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond - Hardcover

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Umesh V. Banakar, PhD, is an independent consultant and advisor to the pharmaceutical industry and academia. He’s made extensive contributions to drug product development, evaluation (both in vitro and clinical), and regulatory affairs. He is the founding Board Member and Principal Scientific Adviser of the Society for Pharmaceutical Dissolution Science [SPDS] and Founding Chairperson of two International Contract Research Organizations. Dr. Banakar is the Founder of Goa – Center for Excellence in Intellectual Property [G-CEIP] in Panaji, Goa, India. He has served as a worldwide testifying/non-testifying expert in over 65 patent litigations in the disciplines of pharmaceutical formulations/technology, clinical investigations, and dissolution testing. Dr. Banakar has received numerous awards for excellence in teaching, research, and scholarly activity along with two Service to Country Awards from the United Nations and a nomination for the distinguished Fulbright Scholar Award for Teaching.

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Explore the cutting-edge of dissolution testing in an authoritative, one-stop resource

In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development.

After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle.

Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety.

This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes:

• A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing
• Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence
• Practical discussions about solubility, dissolution, permeability, and classification systems in drug development
• In-depth examinations of the mechanics of dissolution, including mathematical models and simulations
• An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications
• A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products

Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.