John Wiley & Sons Analytical Scientists in Pharmaceutical Product Development Cover This book by covering a wide range of topics is designed to help the your analytical scientist under.. Product #: 978-1-119-54782-2 Regular price: $100.00 $100.00 Auf Lager

Analytical Scientists in Pharmaceutical Product Development

Task Management and Practical Knowledge

Xiao, Kangping

Cover

1. Auflage November 2020
272 Seiten, Hardcover
Wiley & Sons Ltd

ISBN: 978-1-119-54782-2
John Wiley & Sons

Kurzbeschreibung

This book by covering a wide range of topics is designed to help the your analytical scientist understand how the drug discovery and development process works in industry. It demonstrates to the analytical scientist that functioning successfully in a pharmaceutical company requires more diverse skills than just being able to correctly analyze compounds and molecules. The broader scope of this book is to show, by presenting these topics in a case study format that point out pitfalls of not seeing the larger company objectives, that the complex work of drug discovery and development can only be met by having knowledge of broader managerial skills such as: project management; task management; time management and team management.

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This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. *Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. *Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. *Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment. This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career.

*Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics.

*Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work.

*Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment.

PREFACE: EVERYONE IS A SCIENTIST AND A MANAGER 4

Chapter 1 Pharmaceutical Development at a Glance 6

1. Prescription Medicinal Product Development 6

1.1. Active Pharmaceutical Ingredient (API) Development 7

1.2. Preclinical Research 7

1.3. Clinical Research - Phase 1, Safety and Dosage 8

1.4. Clinical Research - Phase 2, Efficacy and Side Effects 8

1.5. Clinical Research - Phase 3, Efficacy and Monitoring of Adverse Reactions 8

1.6. Clinical Research - Phase 4, Post-Market Safety Monitoring 9

1.7. FDA Approval of a Prescription Medicine 9

2. Over-the-Counter (OTC) Medicinal Product Development 10

2.1. FDA Monograph System 10

2.2. New Drug Application Process for an OTC Medicinal Product 12

2.3. Clinical Trials in OTC Product Development 12

2.4. Prescription to OTC Switch 12

Chapter 2 Analytics in Fast-Paced Product Development 13

1. Overall Development Process for New Products 14

2. Regulatory Strategy and Analytical Development 20

2.1. NDA and ANDA Filing 20

2.2. Module 3 (CMC) of Common Technical Document 22

2.3. Supplements and other Changes to an Approved NDA or ANDA 24

2.3.1. Major Changes - Prior Approval Supplement 25

2.3.2. Moderate Changes - CBE-30 26

2.3.3. Moderate Changes - CBE 27

2.3.4. Minor Changes - Annual Report 27

2.4. Analytical Development with FDA Guidelines in Mind 28

3. ICH Guidelines and Analytical Development 29

4. Pharmacopoeia Monographs and Analytical Development 32

5. Formulation Development and Analytical Development 34

5.1. Method Development based on an Ideal, Comprehensive Quality by Design 35

5.2. Fit-for-Purpose, Teamwork, Knowledge Sharing, and Platform Approach 42

6. Methods for Scale-Up and Manufacturing QC Laboratories 48

7. Process Analytical Technology 51

8. Quality Assurance, Compliance and Analytical Development 53

Chapter 3 Effective, Efficient, and Innovative Analytical Development 56

1. Task Management by Fishbone Diagrams and Time-Bars 57

2. Project Management - Waterfall vs. Agile 71

3. Resource and Cost Estimations 77

4. Desired Skillsets 80

5. Analytical Scientists and Innovation 81

5.1. Think Outside the Box 82

5.2. Think Inside the Box 82

5.3. Be Analytically Creative 83

Chapter 4 Analytical Chemistry and Separation Science at Molecular Level 86

1. Ions and Ionic Strength 88

2. Protonation and De-Protonation 89

3. Hydrolysis of Salts 91

4. Charge-Dipole and Dipole-Dipole Interaction 92

5. Hydrogen Bonding 94

6. Electron Donor-Acceptor Interaction 96

7. Hydration and Solvation Energy 97

8. Hydrophobic Interactions 99

9. Events Happening on the Column Surface 100

10. Example Thought Processes of Chromatographic Method Development 107

10.1. General Considerations 107

10.2. Case Study - Method Development for Assay of Benzalkonium Chloride 109

10.2.1. Method Development 110

10.3. Case Study - Method Development for Analysis of Stereoisomers 113

10.3.1. Considerations of Column Stationary Phases 114

10.3.2. Considerations of Mobile Phase Compositions 115

10.3.3. Degradation Analysis Method Development 119

Chapter 5 Degradation Chemistry and Product Development 128

1. Hydrolysis 129

2. Oxidation 131

3. Reactions of Common Functional Groups 136

3.1. Carboxylic Acid 136

3.2. Hydroxyl Group 139

3.3. Carbon-Carbon Double Bond 139

3.4. Amine Reactions 140

4. Summary of API Degradations 142

5. Stability Study and Forced Degradation 144

5.1. Guidelines on Long-Term Stability Study 144

5.2. Forced Degradation Study Considerations 146

6. Excipient Compatibility 148

6.1. General Remarks 148

6.2. Direct Reactions between APIs and Excipients 149

6.3. Impurities in Excipients 149

6.4. Solid-State Stability - Role of Water 151

6.5. Experimental Considerations - Formulation Relevancy 153

7. Accelerated Stability Evaluation of Finished Products 155

Chapter 6 Practical Statistics for Analytical Development 162

1. Basic Statistical Terms 163

1.1. Sample vs. Population 163

1.2. Mean, Variance, Standard Deviation, Relative Standard Deviation 164

1.3. Normal Distribution 167

1.4. T-Statistics, F-Test, and ANOVA 169

1.5. Hypothesis Setting 173

1.6. Level of Significance and P-Value 177

1.7. Confidence Interval, Prediction Interval, and Tolerance Interval 180

2. Application of Statistics - Analytical Method Equivalency 184

3. Application of Statistics - Stability Data Trending 189

Chapter 7 Thoughts on Conventional Chromatography Practices 192

1. Linear Regression 192

2. Response Factor, Linearity Slope, and y-Intercept 194

3. Relative Response Factor, Linearity Slope, and y-intercept 196

4. Linearity and Method Accuracy 199

5. Injection Precision in System Suitability 201

6. Sample Preparation 203

7. Method Validation and Transfer, Mathematical Exercises or Analytical Sciences 205

8. Miscellaneous Considerations 208
Kangping Xiao - Head of Analytical Development, Bayer Consumer Health R&D in NJ. His team plays critical roles in new product development such as the launch of Aleve PM, Claritin Cool Mint Chewables, and various Aspirin containing products globally. Bachelor of Science Wuhan University, Ph.D. University of Tokyo, Postdoctoral Michigan State University and University of Michigan.