xi
Chapter 30: Postmarket Surveillance............................................................................................................................................................. 467
Linda McBride, RPh, RAC-US
Chapter 31: Advertising and Promotion. ......................................................................................................................................................481
Timothy A. Candy, PharmD, MS, BCPS
Chapter 32: Market Access: Reimbursement and Pricing............................................................................................................................. 499
Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global Parvarsha Nafees, PharmD
Appendices
Regulations and Guidelines Across Chapters – Comparative Matrix. ..........................................................................................................543
Abbreviations and Acronyms. .......................................................................................................................................................................577
Glossary of Terms.......................................................................................................................................................................................... 605
Index............................................................................................................................................................................................................. 627
Case Studies
Case Study 5-1. ...............................................................................................................................................................................................47
Case Study 5-2. ...............................................................................................................................................................................................47
Case Study 6-1. ...............................................................................................................................................................................................59
Case Study 9-1. ...............................................................................................................................................................................................95
Case Study 16-1. ...........................................................................................................................................................................................203
Case Study 16-2. ...........................................................................................................................................................................................204
Case Study 17-1. ...........................................................................................................................................................................................225
Case Study 20-1. ...........................................................................................................................................................................................271
Case Study 20-2. ...........................................................................................................................................................................................272
Case Study 20-3. ...........................................................................................................................................................................................275
Case Study 20-4. ...........................................................................................................................................................................................276
Case Study 20-5. ...........................................................................................................................................................................................277
Case Study 20-6. ...........................................................................................................................................................................................278
Case Study 23-1. ...........................................................................................................................................................................................346
Case Study 31-1. ...........................................................................................................................................................................................492
Figures
Figure 2-1. The Medicinal Product Development Continuum..........................................................................................................................5
Figure 2-2. Traditional de novo product development process vs. product repurposing. ...................................................................................7
Figure 2-3. Phase Transition Duration from Phase 1 through NDA/BLA Authorization. ..............................................................................8
Figure 2-4. Phases of Clinical Research. .........................................................................................................................................................11
Figure 2-5. CTD Triangle............................................................................................................................................................................... 14
Figure 2-6. Communicating value to healthcare stakeholders......................................................................................................................... 15
Figure 2-7. Relationship between Pricing, Reimbursement, and Market Access............................................................................................. 16
Figure 3-1. ICH Process of Harmonization.................................................................................................................................................... 22
Figure 4-1. Final Study Report Items. ............................................................................................................................................................32
Figure 4-2. Nonclinical Safety Evaluation Goals. ...........................................................................................................................................33
Figure 5-1. Continuum of Safety Pharmacology Assessments from Acute to Chronic Toxicity Studies. .......................................................45
Figure 6-1. Drug Exposure Parameters Derived from PK Data...................................................................................................................... 54
Figure 8-1. Genotoxic versus Nongenotoxic Dose-Response Curves.............................................................................................................. 74
Chapter 30: Postmarket Surveillance............................................................................................................................................................. 467
Linda McBride, RPh, RAC-US
Chapter 31: Advertising and Promotion. ......................................................................................................................................................481
Timothy A. Candy, PharmD, MS, BCPS
Chapter 32: Market Access: Reimbursement and Pricing............................................................................................................................. 499
Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global Parvarsha Nafees, PharmD
Appendices
Regulations and Guidelines Across Chapters – Comparative Matrix. ..........................................................................................................543
Abbreviations and Acronyms. .......................................................................................................................................................................577
Glossary of Terms.......................................................................................................................................................................................... 605
Index............................................................................................................................................................................................................. 627
Case Studies
Case Study 5-1. ...............................................................................................................................................................................................47
Case Study 5-2. ...............................................................................................................................................................................................47
Case Study 6-1. ...............................................................................................................................................................................................59
Case Study 9-1. ...............................................................................................................................................................................................95
Case Study 16-1. ...........................................................................................................................................................................................203
Case Study 16-2. ...........................................................................................................................................................................................204
Case Study 17-1. ...........................................................................................................................................................................................225
Case Study 20-1. ...........................................................................................................................................................................................271
Case Study 20-2. ...........................................................................................................................................................................................272
Case Study 20-3. ...........................................................................................................................................................................................275
Case Study 20-4. ...........................................................................................................................................................................................276
Case Study 20-5. ...........................................................................................................................................................................................277
Case Study 20-6. ...........................................................................................................................................................................................278
Case Study 23-1. ...........................................................................................................................................................................................346
Case Study 31-1. ...........................................................................................................................................................................................492
Figures
Figure 2-1. The Medicinal Product Development Continuum..........................................................................................................................5
Figure 2-2. Traditional de novo product development process vs. product repurposing. ...................................................................................7
Figure 2-3. Phase Transition Duration from Phase 1 through NDA/BLA Authorization. ..............................................................................8
Figure 2-4. Phases of Clinical Research. .........................................................................................................................................................11
Figure 2-5. CTD Triangle............................................................................................................................................................................... 14
Figure 2-6. Communicating value to healthcare stakeholders......................................................................................................................... 15
Figure 2-7. Relationship between Pricing, Reimbursement, and Market Access............................................................................................. 16
Figure 3-1. ICH Process of Harmonization.................................................................................................................................................... 22
Figure 4-1. Final Study Report Items. ............................................................................................................................................................32
Figure 4-2. Nonclinical Safety Evaluation Goals. ...........................................................................................................................................33
Figure 5-1. Continuum of Safety Pharmacology Assessments from Acute to Chronic Toxicity Studies. .......................................................45
Figure 6-1. Drug Exposure Parameters Derived from PK Data...................................................................................................................... 54
Figure 8-1. Genotoxic versus Nongenotoxic Dose-Response Curves.............................................................................................................. 74