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Table of Contents
Section I: General Information
Chapter 1: Healthcare Landscape and Drug Development..............................................................................................................................1
Ruchi Gupta, MS
Chapter 2: The Drug Development Continuum, Preclinical to Market Access.................................................................................................5
Darlene Rosario, MBA, RAC-US Pragnesh Donga, MPharm, MBA, RAC-Drugs Kathrin Schalper, PhD, RAC-US, RAC-EU, RAC-Canada, RAC-Devices
Chapter 3: International Harmonization via ICH, WHO, and other Global Initiatives................................................................................. 19
Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global
Section II: Nonclinical Studies
Chapter 4: Principles of Good Laboratory Practice and Nonclinical Development........................................................................................ 29
Kurt Stahl, BS Jennifer G. Brown, PhD, RAC-US
Chapter 5: Safety Pharmacology Studies. .......................................................................................................................................................37
Charlene F. Barroga PhD, DABT Brian M. Roche, PhD, DSP, DABT Simon Authier, DVM, PhD, MSc, MBA
Chapter 6: Pharmacokinetic and Toxicokinetic Studies. .................................................................................................................................53
Tyler Vandivort, PhD, RAC-Drugs, DABT
Chapter 7: Genotoxicity Studies. ....................................................................................................................................................................63
Tyler Vandivort, PhD, RAC-Drugs, DABT
Chapter 8: Carcinogenicity Studies................................................................................................................................................................. 73
Tyler Vandivort, PhD, RAC-Drugs, DABT
Chapter 9: Developmental and Reproductive Toxicity Assessments. ..............................................................................................................85
Charlene F. Barroga, PhD, DABT Alan M. Hoberman, PhD, DABT, ATS
Chapter 10: Regulatory Environmental Risk Assessment of Human Pharmaceuticals................................................................................... 99
Margaret L. Fleming, PhD Jennifer K. Saxe, PhD
Section III: Chemistry, Manufacturing, and Controls
Chapter 11: The Global Regulatory Process for the Registration of Active Substances. ...............................................................................111
Darlene Rosario, MBA, RAC-US Yuwei Zhang, MD, PhD, MPH, MBA Robert Falcone, PhD, FRAPS, FTOPRA
Chapter 12: Coordinating Drug Supply for Clinical and Nonclinical Development. ...................................................................................125
Ajay Babu Pazhayattil, DBA, MPharm Payal Shah, MS, RAC-US
Chapter 13: Pharmaceutical Development Studies and Manufacturing Experience..................................................................................... 141
Komalkumar Patel, MS Nikolaos Zacharias, MSc Kingman Ng, PhD Beat U. Steffen, MSc, MBA, FRAPS Nicole Beard, PhD, MSc
Chapter 14: Analytical Development – Testing and Stability. ......................................................................................................................159
Blaine Van Leuven, MS, RAC-Global Nidhi Kotecha, MPharm, PhD, RAC-Drugs
Table of Contents
Section I: General Information
Chapter 1: Healthcare Landscape and Drug Development..............................................................................................................................1
Ruchi Gupta, MS
Chapter 2: The Drug Development Continuum, Preclinical to Market Access.................................................................................................5
Darlene Rosario, MBA, RAC-US Pragnesh Donga, MPharm, MBA, RAC-Drugs Kathrin Schalper, PhD, RAC-US, RAC-EU, RAC-Canada, RAC-Devices
Chapter 3: International Harmonization via ICH, WHO, and other Global Initiatives................................................................................. 19
Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global
Section II: Nonclinical Studies
Chapter 4: Principles of Good Laboratory Practice and Nonclinical Development........................................................................................ 29
Kurt Stahl, BS Jennifer G. Brown, PhD, RAC-US
Chapter 5: Safety Pharmacology Studies. .......................................................................................................................................................37
Charlene F. Barroga PhD, DABT Brian M. Roche, PhD, DSP, DABT Simon Authier, DVM, PhD, MSc, MBA
Chapter 6: Pharmacokinetic and Toxicokinetic Studies. .................................................................................................................................53
Tyler Vandivort, PhD, RAC-Drugs, DABT
Chapter 7: Genotoxicity Studies. ....................................................................................................................................................................63
Tyler Vandivort, PhD, RAC-Drugs, DABT
Chapter 8: Carcinogenicity Studies................................................................................................................................................................. 73
Tyler Vandivort, PhD, RAC-Drugs, DABT
Chapter 9: Developmental and Reproductive Toxicity Assessments. ..............................................................................................................85
Charlene F. Barroga, PhD, DABT Alan M. Hoberman, PhD, DABT, ATS
Chapter 10: Regulatory Environmental Risk Assessment of Human Pharmaceuticals................................................................................... 99
Margaret L. Fleming, PhD Jennifer K. Saxe, PhD
Section III: Chemistry, Manufacturing, and Controls
Chapter 11: The Global Regulatory Process for the Registration of Active Substances. ...............................................................................111
Darlene Rosario, MBA, RAC-US Yuwei Zhang, MD, PhD, MPH, MBA Robert Falcone, PhD, FRAPS, FTOPRA
Chapter 12: Coordinating Drug Supply for Clinical and Nonclinical Development. ...................................................................................125
Ajay Babu Pazhayattil, DBA, MPharm Payal Shah, MS, RAC-US
Chapter 13: Pharmaceutical Development Studies and Manufacturing Experience..................................................................................... 141
Komalkumar Patel, MS Nikolaos Zacharias, MSc Kingman Ng, PhD Beat U. Steffen, MSc, MBA, FRAPS Nicole Beard, PhD, MSc
Chapter 14: Analytical Development – Testing and Stability. ......................................................................................................................159
Blaine Van Leuven, MS, RAC-Global Nidhi Kotecha, MPharm, PhD, RAC-Drugs