Analytical scientists in pharmaceutical product development: task management and practical knowledge
"Creating pharmaceutical products is a complex endeavor. Even an R&D analytical scientist beside having a wide-ranging knowledge of analytical chemistry, also needs to have more than a cursory understanding of such areas as organic chemistry, material sciences, statistics, formulations, packaging, regulatory affairs, quality systems, etc. Therefore, a capable scientist needs to understand project management, task management, and interpersonal working relationship management, if they are to func…
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- Full title :Analytical scientists in pharmaceutical product development : task management and practical knowledge / Kangping Xiao.
Summary
"Creating pharmaceutical products is a complex endeavor. Even an R&D analytical scientist beside having a wide-ranging knowledge of analytical chemistry, also needs to have more than a cursory understanding of such areas as organic chemistry, material sciences, statistics, formulations, packaging, regulatory affairs, quality systems, etc. Therefore, a capable scientist needs to understand project management, task management, and interpersonal working relationship management, if they are to function successfully in a corporate environment"--
Read More ↓Edition Statements
- Publication Date:2020.
- Edition:First edition
Publication Statements
- Publisher(s):Wiley
- Place of Publication:Hoboken
- Language:eng
- Publication Date:2020.
Notes
Includes index.
The Physical Object
- Description:1 online resource
Edition Identifiers
- ISBN:9781119547785, 1119547784, 9781119547891, 111954789X, 9781119547853, 1119547857
- oclc:on1296823430
- Dewey Decimal:615.1/9
Table of Contents
<P>PREFACE: EVERYONE IS A SCIENTIST AND A MANAGER 4</p> <p><b>Chapter 1 Pharmaceutical Development at a Glance 6</b></p> <p>1. Prescription Medicinal Product Development 6</p> <p>1.1. Active Pharmaceutical Ingredient (API) Development 7</p> <p>1.2. Preclinical Research 7</p> <p>1.3. Clinical Research -- Phase 1, Safety and Dosage 8</p> <p>1.4. Clinical Research -- Phase 2, Efficacy and Side Effects 8</p> <p>1.5. Clinical Research -- Phase 3, Efficacy and Monitoring of Adverse Reactions 8</p> <p>1.6. Clinical Research -- Phase 4, Post-Market Safety Monitoring 9</p> <p>1.7. FDA Approval of a Prescription Medicine 9</p> <p>2. Over-the-Counter (OTC) Medicinal Product Development 10</p> <p>2.1. FDA Monograph System 10</p> <p>2.2. New Drug Application Process for an OTC Medicinal Product 12</p> <p>2.3. Clinical Trials in OTC Product Development 12</p> <p>2.4. Prescription to OTC Switch 12</p> <p><b>Chapter 2 Analytics in Fast-Paced Product Development 13</b></p> <p>1. Overall Development Process for New Products 14</p> <p>2. Regulatory Strategy and Analytical Development 20</p> <p>2.1. NDA and ANDA Filing 20</p> <p>2.2. Module 3 (CMC) of Common Technical Document 22</p> <p>2.3. Suppleme…
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