Safety pharmacology is a branch of pharmacology specialising in detecting and investigating potential undesirable pharmacodynamic effects of new chemical entities NCEs on physiological functions in relation to exposure in the therapeutic range and above. Safety pharmacology studies are required to be completed prior to human exposure i. The following key issues have to be considered within safety pharmacology: . The only detailed guidelines indicating the requirements from drug regulatory authorities for general pharmacology studies were from the Ministry of Health, Labour, and Welfare. Preclinical safety pharmacology integrates in silico , in vitro and in vivo approaches.
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Surveys of the pharmaceutical industry, regulatory agencies and the audience attending the 4th Annual Meeting of the Safety Pharmacology Society have helped identify and address areas of controversy, as well as those challenges that have emerged since implementation of the guidance worldwide.
The guidance provides for "Good Laboratory Practice" compliant "safety pharmacology core battery" of studies that are generally performed prior to first administration to humans. There was also discussion of when these studies are needed in relation to the clinical development plan. Representatives from the pharmaceutical industry and regulatory agencies see the implementation of ICH S7A as a major step forward towards identifying the risk to Phase 1 and 2 volunteers and patients.
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Optional text in email:. Save Cancel. Create a file for external citation management software Create file Cancel. Full-text links Cite Favorites. Bass AS, et al. Handb Exp Pharmacol. PMID: Review. Ewart L, et al. J Pharmacol Toxicol Methods. Epub May 9. Benchmarking safety pharmacology regulatory packages and best practice. Lindgren S, et al. Epub Jul PMID: Pugsley MK, et al. Epub May Non-clinical evaluation of ventricular repolarization ICH S7B : results of an interim survey of international pharmaceutical companies.
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Challenges and Lessons Learned Since Implementation of the Safety Pharmacology Guidance ICH S7A
U.S. Food and Drug Administration
ICH S7A Safety pharmacology studies for human pharmaceuticals