Good Clinical Practices in Pharmaceuticals

1. Auflage 2026
ISBN: 978-1-032-52525-9
Verlag: Taylor & Francis Ltd

Buch, Englisch, 206 Seiten, Format (B × H): 156 mm x 234 mm, Gewicht: 380 g

Reihe: Drugs and the Pharmaceutical Sciences

Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable.

- Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted.

- Provides the most up-to-date and best practices, techniques, and methodologies in good clinical practice.

- Discusses applicable laws and regulations supporting GCP compliance, quality and operations.

- Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.

Zielgruppe

Postgraduate, Professional Practice & Development, Professional Reference, Professional Training, and Undergraduate Advanced

Autoren/Hrsg.

Bunn, Graham P.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Technische Wissenschaften Maschinenbau | Werkstoffkunde Produktionstechnik Fertigungstechnik

Inhaltsverzeichnis

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

Über Autor(innen)

Graham P. Bunn has been the president of GB Consulting LLC, in Pennsylvania, since 2000 and provides regulatory compliance guidance and technical consulting services for pharmaceutical, biotechnology, and other FDA-related industries. His experience includes supporting and leading teams for quality systems assessments, regulatory action responses and remediations (FDA483, Warning Letter, Consent Decree), and preparing sites to host regulatory inspections. He has developed and facilitated numerous highly interactive learning workshops worldwide, including Aseptic Training Programs, Batch Record Reviews, QA on the Floor, and aseptic training support for Compounding Centers. Before founding GB Consulting LLC, Graham gained extensive experience through various management positions in the pharmaceutical industry with SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career includes management responsibilities as a corporate compliance auditor, quality assurance, validation, and clinical trials manufacturing and packaging. Graham is the editor of Good Manufacturing Practices for Pharmaceuticals and Good Laboratory Practices for Non-Clinical Studies and the author of several book chapters/journal articles. Graham received a BSc in pharmacy from Brighton University, England, and an MSc in Quality Assurance and Regulatory Affairs from Temple University, Philadelphia, and is a member of the Regulatory Affairs Professional Society (RAPS).