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Societies

The Safety Pharmacology Society incorporated in 2000 as a nonprofit organization that promotes knowledge, development, application, and training in Safety Pharmacology. The discussion group meetings attract participants from the US, Europe, and Japan and includes scientists, members of regulatory agencies, academicians, and vendors of equipment and services.

Regulatory Guidances

Safety Pharmacology ICH S7A Guidelines July 2001 – Guideline on Safety Pharmacology Studies for Human Pharmaceuticals: Definitions, objectives, and recommendations on the design and conduct of safety pharmacology studies for non-clinical safety evaluation of new chemical entities and biotechnology-derived products for human use.

ICH S7B (Final Oct., 2005) – Guideline on The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals: Nonclinical testing strategy for assessing the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk.

Complete list of ICH Drug Safety Guidelines

CHMP Draft guideline on non-clinical investigation of dependence potential

Center for Drug Evaluation and Research (CDER): Federal Drug Administration (FDA) Guidances on Pharmacology, Toxicology and Pharmacokinetics.

Code of Federal Regulations (CFR) 21 - The government posting with pdf documents for each section.

Chapter 1 - Food and Drug Administration, Dept. of Health and Human Services. (Part 11 - Electronic Records; Electronic Signatures)

Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies. For more information, see the easily used format from Temple University.

FDA Code of Federal Regulations Mini-Handbooks. Full-text, pocket-sized 3.75" x 6.25" versions of FDA regulations.

Guidance on Electronic Submissions in Electronic Format – General Considerations

Contract Research Effectiveness Tips

 

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