Regulatory Affairs Professionals Society vii
Section I: General Information
Chapter 1: The Drug Development Continuum, Preclinical to Market Access ..............................................................................................3
Darlene (Dar) Rosario, MBA, BS, RAC-US Pragnesh Donga, MPharm, MBA, RAC-Drugs Kathrin Schalper, PhD, RAC-Devices, RAC-US, RAC-CAN, RAC-EU
Chapter 2: International Harmonization via ICH, WHO, and Other Global Initiatives ..............................................................................19
Linda McBride, RPh, RAC-US
Section II: Nonclinical Studies
Chapter 3: Principles of Good Laboratory Practice and Nonclinical Development .......................................................................................27
Neel Kamal Sharma, PhD, MS Jennifer G. Brown, PhD, RAC-US
Chapter 4: Safety Pharmacology Studies ........................................................................................................................................................37
Charlene F. Barroga PhD, DABT Brian M. Roche, PhD, DSP, DABT Simon Authier, DVM, PhD, MBA, MSc, DSP
Chapter 5: Pharmacokinetic and Toxicokinetic Studies .................................................................................................................................53
Tyler Vandivort, PhD, DABT, RAC-Drugs Dhanraj Deshmukh, PhD, DABT
Chapter 6: Acute and Chronic Toxicity Assessments ....................................................................................................................................65
Charles Lambert, PhD, DABT, ERT Brante P. Sampey, PhD, DABT
Chapter 7: Local Tolerance Studies ...............................................................................................................................................................77
Ramesh Subramani, DVM, DABT, ERT, DSP, RAC-US
Chapter 8: Genotoxicity Studies .....................................................................................................................................................................83
Tyler Vandivort, PhD, DABT, RAC-Drugs Ramesh Subramani, DVM, DABT, ERT, DSP, RAC-US
Chapter 9: Carcinogenicity Studies ................................................................................................................................................................95
Tyler Vandivort, PhD, DABT, RAC-Drugs Kalaiselvan Ponnusamy, MVSc, DIBTP, DICVP, DABT
Chapter 10: Developmental and Reproductive Toxicity Assessments ..........................................................................................................107
Charlene F. Barroga, PhD, DABT Alan M. Hoberman, PhD, DABT, ATSF
Chapter 11: Regulatory Environmental Risk Assessment of Human Pharmaceuticals ................................................................................121
Margaret L. Fleming, PhD Sagar Thakali, PhD, IBERA Jennifer K. Saxe, PhD, MBA
Section III: Chemistry, Manufacturing, and Controls
Chapter 12: The Global Regulatory Process for the Registration of Active Substances ..............................................................................137
Darlene (Dar) Rosario, MBA, BS, RAC-US Yuwei Zhang, MD, PhD, MPH, MBA Robert Falcone, PhD, FTOPRA, FRAPS
Table of Contents
Section I: General Information
Chapter 1: The Drug Development Continuum, Preclinical to Market Access ..............................................................................................3
Darlene (Dar) Rosario, MBA, BS, RAC-US Pragnesh Donga, MPharm, MBA, RAC-Drugs Kathrin Schalper, PhD, RAC-Devices, RAC-US, RAC-CAN, RAC-EU
Chapter 2: International Harmonization via ICH, WHO, and Other Global Initiatives ..............................................................................19
Linda McBride, RPh, RAC-US
Section II: Nonclinical Studies
Chapter 3: Principles of Good Laboratory Practice and Nonclinical Development .......................................................................................27
Neel Kamal Sharma, PhD, MS Jennifer G. Brown, PhD, RAC-US
Chapter 4: Safety Pharmacology Studies ........................................................................................................................................................37
Charlene F. Barroga PhD, DABT Brian M. Roche, PhD, DSP, DABT Simon Authier, DVM, PhD, MBA, MSc, DSP
Chapter 5: Pharmacokinetic and Toxicokinetic Studies .................................................................................................................................53
Tyler Vandivort, PhD, DABT, RAC-Drugs Dhanraj Deshmukh, PhD, DABT
Chapter 6: Acute and Chronic Toxicity Assessments ....................................................................................................................................65
Charles Lambert, PhD, DABT, ERT Brante P. Sampey, PhD, DABT
Chapter 7: Local Tolerance Studies ...............................................................................................................................................................77
Ramesh Subramani, DVM, DABT, ERT, DSP, RAC-US
Chapter 8: Genotoxicity Studies .....................................................................................................................................................................83
Tyler Vandivort, PhD, DABT, RAC-Drugs Ramesh Subramani, DVM, DABT, ERT, DSP, RAC-US
Chapter 9: Carcinogenicity Studies ................................................................................................................................................................95
Tyler Vandivort, PhD, DABT, RAC-Drugs Kalaiselvan Ponnusamy, MVSc, DIBTP, DICVP, DABT
Chapter 10: Developmental and Reproductive Toxicity Assessments ..........................................................................................................107
Charlene F. Barroga, PhD, DABT Alan M. Hoberman, PhD, DABT, ATSF
Chapter 11: Regulatory Environmental Risk Assessment of Human Pharmaceuticals ................................................................................121
Margaret L. Fleming, PhD Sagar Thakali, PhD, IBERA Jennifer K. Saxe, PhD, MBA
Section III: Chemistry, Manufacturing, and Controls
Chapter 12: The Global Regulatory Process for the Registration of Active Substances ..............................................................................137
Darlene (Dar) Rosario, MBA, BS, RAC-US Yuwei Zhang, MD, PhD, MPH, MBA Robert Falcone, PhD, FTOPRA, FRAPS
Table of Contents