Pharmaceutical product development : insights into pharmaceutical processes, management and regulatory affairs /

Pharmaceutical product development : insights into pharmaceutical processes, management and regulatory affairs / edited by Vandana B. Patravale, John I. Disouza, Maharukh Rustomjee.

"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 equip...

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Bibliographic Details
Online Access: Full Text (via Taylor & Francis)
Other Authors: Patravale, Vandana B. (Editor), Disouza, John I. (Editor), Rustomjee, Maharukh (Editor)
Other title:Pharmaceutical product development (Patravale)
Insights into pharmaceutical processes management and regulatory affairs
Format: eBook
Language:English
Published: Boca Raton, FL : CRC Press, [2016]
Series:Online access with DDA: Askews (Medicine)
Subjects:
Drug development.
Drugs > Design.
Pharmaceutical industry.
Drug development
Drugs > Design
Pharmaceutical industry
Table of Contents:
  • Chapter 1. Product life cycle management : stages of new product development / Preshita P. Desai, John I. Disouza and Vandana B. Patravale
  • chapter 2. Principal concepts in pharmaceutical product design and development / Preshita P. Desai and Maharukh T. Rustomjee
  • chapter 3. Regulatory and intellectual property aspects during pharmaceutical product development / Preshita P. Desai, Sivagami V. Bhatt and Mahalaxmi A. Andheria
  • chapter 4. Strategies in pharmaceutical product development / Maharukh T. Rustomjee
  • chapter 5. Design of experiments : basic concepts and its application in pharmaceutical product development / Amit G. Mirani and Vandana B. Patravale
  • chapter 6. Preformulation studies : role in pharmaceutical product development / Swati S. Vyas, Amita P. Surana and Vandana B. Patravale
  • chapter 7. Formulation development and scale-up / Amit G. Mirani, Priyanka S. Prabhu and Maharukh T. Rustomjee
  • chapter 8. Process validation and postapproval changes / Amit G. Mirani and Maharukh T. Rustomjee
  • chapter 9. 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
  • chapter 10. Packaging of pharmaceuticals / Manasi M. Chogale and Maharukh T. Rustomjee
  • chapter 11. Quality management systems in pharmaceutical manufacturing / Abhinandan R. Patil and Maharukh T. Rustomjee
  • chapter 12. A new era of drug products : opportunities and challenges / Preshita P. Desai, John I. Disouza and Vandana B. Patravale.

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