| Description |
1 online resource (xiii, 411 pages) : illustrations |
| Series |
Online access with DDA: Askews (Medicine)
|
| 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 |
| Summary |
"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"--Provided by publisher |
| Bibliography |
Includes bibliographical references |
| Notes |
English |
|
Print version record |
| Subject |
Drug development.
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Drugs -- Design.
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Pharmaceutical industry
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Technology, Pharmaceutical -- methods
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Drug Industry -- organization & administration
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Drug Design
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Drug Industry
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Research Design
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Drug Approval
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MEDICAL -- Pharmacology.
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Drug development
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Drugs -- Design
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Pharmaceutical industry
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| Form |
Electronic book
|
| Author |
Patravale, Vandana B., editor
|
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Disouza, John I., editor
|
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Rustomjee, Maharukh, editor
|
| ISBN |
9781498730785 |
|
1498730787 |
|
9780429188817 |
|
0429188811 |
|
