Comprehensive Guide to Generic Product Development: Theory and Practice

By Veerareddy Prabhakar Reddy and Muralidhar Rao Akkaladevi

Mastering the Science and Art of Generic Drug Development

This definitive guide is an essential resource for pharmaceutical professionals, academicians, and students seeking to navigate the intricate landscape of generic product development.

Comprehensive Guide to Generic Product Development: Theory and Practice seamlessly blends foundational concepts with cutting-edge methodologies to provide a holistic understanding of the subject.

A Detailed Exploration of the Subject

Gain insight into formulation design, process optimization, and regulatory pathways.

Understand the pharmacokinetics, bioequivalence studies, and analytical validations critical for successful product approval.

Explore stability testing protocols, packaging development, and the role of Quality by Design (QbD) in ensuring product efficacy and safety.

Delve into real-world examples, case studies, and global regulatory perspectives that emphasize practical applications in a competitive marketplace.

Why This Book Stands Out

Written by experts with decades of experience, this guide provides a clear, structured, and accessible framework, making it an indispensable companion for professionals and learners in the pharmaceutical sciences.