Fundamentals of Pharmaceutical and Biologic Regulations: A Global Perspective
viii Regulatory Affairs Professionals Society
Chapter 13: Biologics and Small Molecules .................................................................................................................................................151
Ben McLaughlin, MSE
Chapter 14: Coordinating Drug Supply for Clinical and Nonclinical Development ...................................................................................163
Ajay Babu Pazhayattil, DBA, MPharm, CPGP
Chapter 15: Pharmaceutical Development Studies and Manufacturing Experience ....................................................................................173
Komalkumar Patel, MS Nikolaos Zacharias, MS Kingman Ng, PhD Beat U. Steffen, MSc, MBA, RAC-Devices, FRAPS Ricki A. Chase, MS Nicole Beard,
PhD, MSc
Chapter 16: Analytical Method Lifecycle: Management, Practice, and Regulatory Integration ..................................................................201
Nidhi Kotecha, PhD, MPharm, RAC-Drugs Siegfried Schmitt, PhD
Section IV: Clinical Trials
Chapter 17: Conducting Clinical Trials: Drug Application Types, Data Requirements, and Obtaining Marketing Approval ..................217
Sharry Arora, MPharm, MTOPRA, RAC-Drugs
Chapter 18: Phases of Development (1, 2, 3, 4) ...........................................................................................................................................229
Rowena Cook, MS, RAC-Global, RCC-IVDR Siegfried Schmitt, PhD
Chapter 19: Enhancing Diversity in Clinical Trials .....................................................................................................................................257
Monique J. Carter, MS, FRAPS Zaida Recinos-Vasquez, MS, MS Leonor Saldanha, PhD, MS Jennifer Duru, PharmD
Chapter 20: Health Authority Interactions ..................................................................................................................................................275
Jewell D. Martin, MBA, MA, PMP, RAC-US Marcello Milano, MSc Angela W. Corona, PhD
Chapter 21: Pediatrics ..................................................................................................................................................................................297
Karl-Heinz Huemer, MD, PhD Linda McBride, RPh, RAC-US
Chapter 22: Region-Specific Studies ............................................................................................................................................................313
Consuela Stewart
Section V: Marketing Authorization
Chapter 23: Core Labeling: An Important Global Tool ..............................................................................................................................329
Cathleen A. O’Connell, PhD, MS, RPh Stephanie Turri Lockman, MS
Chapter 24: Framework for Benefit-Risk Assessment .................................................................................................................................335
Cristina Damatarca, MD, PGD
Chapter 25: eCTD and Digital Applications ...............................................................................................................................................349
Danini Y. Marin, MSc Katelyn Jean Mulligan, EMBA, MS
Chapter 26: Expedited Approval Pathways ..................................................................................................................................................359
Yingying Liu, MSc
Chapter 27: Dossier Requirements ...............................................................................................................................................................401
Jesshanie Tabaniag Kholoud M. Abdelfattah, MSc, CSRT-HMS Danini Y. Marin, MSc Salah Shawky, DrBA Hannah Jin, BSc Brix Gil Bayuga, RPh
Chapter 28: Combination Products .............................................................................................................................................................449
Beat U. Steffen, MSc, MBA, RAC-Devices, FRAPS Ricki A. Chase, MS
viii Regulatory Affairs Professionals Society
Chapter 13: Biologics and Small Molecules .................................................................................................................................................151
Ben McLaughlin, MSE
Chapter 14: Coordinating Drug Supply for Clinical and Nonclinical Development ...................................................................................163
Ajay Babu Pazhayattil, DBA, MPharm, CPGP
Chapter 15: Pharmaceutical Development Studies and Manufacturing Experience ....................................................................................173
Komalkumar Patel, MS Nikolaos Zacharias, MS Kingman Ng, PhD Beat U. Steffen, MSc, MBA, RAC-Devices, FRAPS Ricki A. Chase, MS Nicole Beard,
PhD, MSc
Chapter 16: Analytical Method Lifecycle: Management, Practice, and Regulatory Integration ..................................................................201
Nidhi Kotecha, PhD, MPharm, RAC-Drugs Siegfried Schmitt, PhD
Section IV: Clinical Trials
Chapter 17: Conducting Clinical Trials: Drug Application Types, Data Requirements, and Obtaining Marketing Approval ..................217
Sharry Arora, MPharm, MTOPRA, RAC-Drugs
Chapter 18: Phases of Development (1, 2, 3, 4) ...........................................................................................................................................229
Rowena Cook, MS, RAC-Global, RCC-IVDR Siegfried Schmitt, PhD
Chapter 19: Enhancing Diversity in Clinical Trials .....................................................................................................................................257
Monique J. Carter, MS, FRAPS Zaida Recinos-Vasquez, MS, MS Leonor Saldanha, PhD, MS Jennifer Duru, PharmD
Chapter 20: Health Authority Interactions ..................................................................................................................................................275
Jewell D. Martin, MBA, MA, PMP, RAC-US Marcello Milano, MSc Angela W. Corona, PhD
Chapter 21: Pediatrics ..................................................................................................................................................................................297
Karl-Heinz Huemer, MD, PhD Linda McBride, RPh, RAC-US
Chapter 22: Region-Specific Studies ............................................................................................................................................................313
Consuela Stewart
Section V: Marketing Authorization
Chapter 23: Core Labeling: An Important Global Tool ..............................................................................................................................329
Cathleen A. O’Connell, PhD, MS, RPh Stephanie Turri Lockman, MS
Chapter 24: Framework for Benefit-Risk Assessment .................................................................................................................................335
Cristina Damatarca, MD, PGD
Chapter 25: eCTD and Digital Applications ...............................................................................................................................................349
Danini Y. Marin, MSc Katelyn Jean Mulligan, EMBA, MS
Chapter 26: Expedited Approval Pathways ..................................................................................................................................................359
Yingying Liu, MSc
Chapter 27: Dossier Requirements ...............................................................................................................................................................401
Jesshanie Tabaniag Kholoud M. Abdelfattah, MSc, CSRT-HMS Danini Y. Marin, MSc Salah Shawky, DrBA Hannah Jin, BSc Brix Gil Bayuga, RPh
Chapter 28: Combination Products .............................................................................................................................................................449
Beat U. Steffen, MSc, MBA, RAC-Devices, FRAPS Ricki A. Chase, MS