Good Clinical Practices in Pharmaceuticals

Preface
About the Editor
List of Contributors
Introduction

1 Regulatory Application Requirements
Shanthi Ganeshan and Connie Freund

2 An overview of Good Clinical Practices
John Klein and Sonya Edgerton

3 Quality by Design, Critical to Quality Factors - ICH E8 (R1)
Sam Sather and Jennifer Lawyer

4 Good Clinical Practice ICH E6 (R2 and R3)
John Klein and Sonya Edgerton

5 Clinical Safety Data Management ICH E2A
Karen Truhe

6 21 CFR 50 - Informed Consent
Joe Near

7 21 CFR 54 - Financial Disclosure
Glenda Guest

8 21 CFR 56 - Institutional Review Boards
Aurea Flores

9 Protected Health Information and Privacy in Clinical Trials (HIPAA)
Sam Sather

10 Good Pharmacovigilance Practices (GVP)
Jessica Chu

11 Data Integrity and 21CFR11 for GCPs
Randall Basinger

12 Preparing for FDA inspections at sponsor/investigator sites
Tommy Lee and Sam Sather

13 Regulations relating to the Placebo response in Clinical research
Graham Bunn and Arthur Ooghe

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• Biologia, ciências da vida
• Química
• Tecnologia farmacêutica
• Farmacologia

Laboratory testing regulations;Regulatory deliverables;Testing facility management and compliance;Contract Research Organization (CRO);Good Laboratatory Practice;Good Manufacturing Practice;Good Clinical Practice;GLP;GMP;GCP