Veterinary Clinical Trials from Concept to Completion

ISBN-13: 9781574911213 / Angielski / Twarda / 2001 / 348 str.

Dent Dent; Nigel Dent; Ramzan Visanji

Opis

This book is a guide to both the novice and the established practitioner, offering alternative ways of conducting clinical trials that are in compliance with regulations. A global panel of experts shares its experiences in clinical studies involving all of the major species.

Spis treści

Introduction and Overview of Setting Up Studies to Good Clinical Practice, N. DentInternational Harmonization and the Conduct of Clinical Studies to Support the Approval of New Animal Drugs: The U.S. Perspective, H.M. Schoenemann, IIIThe Role of the Investigator, M. ProvenThe Role of the Monitor, A.W. HillQuality Assurance on Veterinary Clinical Trials, R. MuserSetting Up GCP Trials in Fish, J. Stone and A. McLeanSetting GCP Trials in Poultry, R.J. GrantSetting Up GCP Trials in Companion Animals, S. LesterSetting Up GCP Trials in Pigs, A.R. PetersSetting Up GCP Trials in Calves, J. MurraySetting Up GCP Trials in Sheep, J. BarleySetting Up GCP Trials in Horses and Ponies, D. BakerGenetically Modified Micro-Organisms and GCP Studies, V. CarnContract Research Farms and Their Involvement with GCP Studies, B. Drew and H. BiggadikeThe Practicing Veterinarian's Role in Clinical Trials, J. CarrStandard Operating Procedures, R. VisanjiThe Generic Protocol, C. DentHow to Write the Final Study Report, K.L. Ankenbauer-Perkins and A.M. AlexanderData, Statistical Analysis and Reporting for Veterinary Clinical Trials, G. GettinbyRegistration Submissions for Veterinary Medicines, G. CowanLarge-Scale Production of Ectoparasites for Use in Veterinary Trials, M. Murphy, L. Moran, S. Conroy, and C. CaulfieldAuditing GCP Trials, Z. CarrMultisite Studies, L. WhitfieldAppendicesIndex

O autorze

Ramzan Visanji, Nigel Dent