1st Edition

Pharmaceutical Product Development
Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

ISBN 9781498730778
Published March 3, 2016 by CRC Press
470 Pages 16 Color & 91 B/W Illustrations

USD $200.00

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Book Description

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.

Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.

Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.

The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Table of Contents

Product Life Cycle Management: Stages of New Product Development
Preshita P. Desai, John I. Disouza and Vandana B. Patravale

Principle Concepts in Pharmaceutical Product Design and Development

Preshita P. Desai and Maharukh T. Rustomjee

Regulatory and Intellectual Property Aspects during Pharmaceutical Product Development

Preshita P. Desai, Sivagami V. Bhatt and Mahalaxmi A. Andheria

Strategies in Pharmaceutical Product Development

Maharukh T. Rustomjee

Design of Experiments: Basic Concepts and Its Application in Pharmaceutical Product Development

Amit G. Mirani and Vandana B. Patravale

Preformulation Studies: Role in Pharmaceutical Product Development

Swati S. Vyas, Amita P. Surana and Vandana B. Patravale

Formulation Development and Scale-Up

Amit G. Mirani, Priyanka S. Prabhu and Maharukh T. Rustomjee

Process Validation and Postapproval Changes

Amit G. Mirani and Maharukh T. Rustomjee

Case Studies on Pharmaceutical Product Development

Ankit A. Agrawal, Manasi M. Chogale, Preshita P. Desai, Priyanka S. Prabhu, Sandip M. Gite, Vandana B. Patravale, Maharukh T. Rustomjee and John I. Disouza

Packaging of Pharmaceuticals

Manasi M. Chogale and Maharukh T. Rustomjee

Quality Management Systems in Pharmaceutical Manufacturing

Abhinandan R. Patil and Maharukh T. Rustomjee

A New Era of Drug Products: Opportunities and Challenges

Preshita P. Desai, John I. Disouza and Vandana B. Patravale

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Edited by

Vandana B. Patravale, PhD, is a professor of pharmaceutics at Department of Pharmaceutical Sciences and Technology of the Institute of Chemical Technology in India. She has written over 90 refereed publications and seven book chapters and has been granted three patents with another 24 patents in the pipeline and 3 trademark registries to her credit. Dr. Patravale has worked on various industrial, national and international projects throughout her career and has known expertise in the area of pharmaceutics. Her areas of expertise include conventional and modified release dosage forms, medical device development viz. coronary stents, intrauterine devices, nanodiagnostics, novel nanocarriers with major emphasis on malaria, cancer and neurodegenerative disorders, and formulation strategies to enhance bioavailability and/or targeting.

John I. Disouza, PhD, is a professor in pharmaceutics and principal at Tatyasaheb Kore College of Pharmacy in Warananagar, India. He has over 15 years of teaching and research experience. He also has an executive MBA (Higher education) degree. Dr. Disouza has written two books and published over 50 research papers in peer reviewed journals. He has worked in diverse research areas including herbal formulations, micro/nanoparticulate, self-emulsifying, liposomal, fast and modified release drug delivery systems. His areas of interest include probiotics, novel diagnostic tools and therapies in cancer, and structural modifications of natural polymers for their pharmaceutical potential. He is an active consultant to pharmaceutical industry.

Mrs. Maharukh Rustomjee is the founder, director, and chief operating officer of Rubicon Research Pvt. Limited and serves on the Board of Directors for the company. She has 30 years of experience in the dosage form development and drug delivery platform technologies in all phases of product development from product design through commercial manufacturing. She has spearheaded Rubicon’s drug delivery technology effort, built a strong Intellectual Property knowledge base, developed complex generics, worked on FTF opportunities for leading generics, and worked on LCM opportunities with Innovator Pharma companies. She is the holder of numerous patents in the area of drug delivery systems.