Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: A Comprehensive Guide

Stay at the forefront of dissolution testing with this authoritative, one-stop resource. In “Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond”, renowned pharmaceutical advisor and consultant Dr. Umesh Banakar provides an exhaustive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development.

Fundamentals and Applications of Pharmaceutical Dissolution Testing

Delve into the foundations of dissolution testing, exploring its importance beyond mere quality control. This comprehensive guide discusses common testing practices and methods, as well as their associated challenges and issues, throughout the drug development life cycle.

Extensive Coverage of Key Topics

With 19 chapters and over 1100 references, this volume offers a wide-ranging exploration of topics, including:

• Automation in dissolution testing
• Generic and biosimilar drug development
• Prior art and patent considerations
• Clinical safety and regulatory compliance

A One-Stop Resource for Pharmaceutical Professionals

This book provides a single, authoritative source for information otherwise scattered across multiple regulatory regimes. It is an essential guide for:

• Drug product development and formulation scientists
• Quality control and assurance professionals
• Regulators and intellectual property assessors

Comprehensive Coverage of Bioavailability and Bioequivalence

Explore the foundations and drug development applications of bioavailability and bioequivalence, including:

• Solubility, dissolution, permeability, and classification systems in drug development
• In-depth examinations of the mechanics of dissolution, including mathematical models and simulations
• Elaborate assessments of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications

Global Regulatory Expectations and Requirements

Stay up-to-date with the latest methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products.

Published by Wiley, this 560-page hardcover volume (1st edition, January 19, 2022) is an indispensable resource for pharmaceutical professionals seeking to stay at the forefront of dissolution testing.

ISBN-10: 1119634601 | ISBN-13: 978-1119634607