Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs, 1st Edition (e-Book) book cover

Pharmaceutical Product Development

Insights Into Pharmaceutical Processes, Management and Regulatory Affairs, 1st Edition

Edited by Vandana B. Patravale, John I. Disouza, Maharukh Rustomjee

CRC Press

447 pages

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Hardback: 9781498730778
pub: 2016-03-03
eBook (VitalSource) : 9780429188817
pub: 2016-05-25
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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

Table of Contents

Product Life Cycle Management: Stages of New Product Development. Principle Concepts in Pharmaceutical Product Design and Development. Regulatory and Intellectual Property Aspects during Pharmaceutical Product Development. Strategies in Pharmaceutical Product Development. Design of Experiments: Basic Concepts and Its Application in Pharmaceutical Product Development. Preformulation Studies: Role in Pharmaceutical Product Development. Formulation Development and Scale-Up. Process Validation and Postapproval Changes. Case Studies on Pharmaceutical Product Development. Packaging of Pharmaceuticals. Quality Management Systems in Pharmaceutical Manufacturing. A New Era of Drug Products: Opportunities and Challenges.

About the Editors

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 desi

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology