Title: Veterinary Clinical Trials from Concept to Completion
Editors: Nigel Dent and Ramzan Visanji
Publisher: CRC Press / Taylor & Francis Group
Publication Year: 2001
Veterinary Clinical Trials from Concept to Completion is an authoritative, end-to-end handbook covering the design, execution, and regulatory compliance of clinical studies for animal health products. Conceived and edited by seasoned industry leaders Nigel Dent and Ramzan Visanji, this comprehensive work translates Good Clinical Practice (GCP) and international harmonization guidelines into practical, field-tested methodologies. It serves as an essential desktop reference for clinical research associates, study monitors, veterinary investigators, pharmaceutical project managers, and regulatory affairs professionals worldwide.
Key Topics Covered:
- Good Clinical Practice (GCP) & Regulatory Harmonization: Comprehensive overview of VICH guidelines, FDA and international regulatory oversight, compliance frameworks, and study approval pathways for new animal drugs.
- Study Roles, Responsibilities & Quality Assurance: In-depth guidance defining the operational duties of clinical sponsors, monitors, study investigators, and quality assurance auditing teams during trial execution.
- Species-Specific Trial Design: Tailored protocols and logistics for setting up GCP-compliant field studies across companion animals, livestock (calves, pigs, sheep), horses, poultry, and aquatic species.
- Documentation, Protocol Design & Reporting: Step-by-step methodologies for drafting generic protocols, Standard Operating Procedures (SOPs), informed consent forms, statistical analysis plans, and final regulatory submissions.
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