If you are interested in peripheral arterial occlusive disease, epilepsy, irritable bowel syndrome or diagnostic agents you should check out the following. They give background information on the disease and incidence as well as providing guidance on the recommended drug development programme, including the type of trials that should be carried out, patient population, trial design, recommended efficacy and safety assessments, and type of analysis.
Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders (CPMP/EWP/566/98)
Note for Guidance on Clinical Investigation of Medicinal
Products for the Treatment of Peripheral Arterial Occlusive Disease
Concept Paper on the Development of a CPMP Points
to Consider on the Evaluation of Drugs for the Treatment of Irritable
Points to Consider on the Evaluation of Diagnostic Agents (CPMP/EWP/1119/98)
The guidance on bioavailability and bioequivalence studies is essential reading for those of you involved with generic compounds. It provides a clear definition of the two terms and explains how these studies should be conducted and analysed, and the acceptance criteria for the pharmacokinetic parameters tested:
Note for Guidance on the Investigation of Bioavailability
and Bioequivalence (CPMP/EWP/QWP/1401/98 DRAFT).
Note for Guidance on Safety Pharmacology Studies for Human Pharmaceuticals (CPMP/ICH/539/00 ICH Topic 57A) discusses what safety pharmacology studies are, why they are needed and how they should be designed. It provides a useful overview of such pharmacology studies.
Note for Guidance on Non-clinical Local Tolerance Testing of Medicinal Products (CPMP/SWP/2145/00) covers the design of local tolerance tests and the type and extent of testing required, with specific information for the ocular, dermal, parenteral, rectal and vaginal routes of administration.
Note for Guidance on Specifications:Test Procedures
and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations
and Herbal Medicinal Products (CPMP/QWP/2820/00 DRAFT)
Concept Paper on the Development of a CPMP/CVMP
Note for Guidance on the Quality of Water for Pharmaceutical Use (CPMP/QWP/1676/00
The guidance paper on tradenames has also been revised. This details situations where a proposed tradename may be refused for reasons of confusion with an existing product or misleading therapeutic or pharmaceutical connotations.
Revised Guidance Paper on the Acceptability of Tradenames for Human Medicinal Products Processed through the Centralised Procedure (CPMP/328/98 rev. 2 DRAFT)
For those of you involved in producing regulatory documents, the ICH guideline on the common technical document gives an idea of how things will be organised in the future:
Common Technical Document for the Registration of Pharmaceuticals for Human Use: Organisation of Common Technical Document (CPMP/ICH/2887/99 ICH Topic 4)
The majority of these guidelines are written in a clear, easy to understand way - perhaps they have employed a few medical writers! They can provide a good overview of a particular therapeutic area or type of study. There is also a lot of other useful stuff on this web site, but thats another article, for another issue of TWS - any volunteers?