2003, Clinical Pharmacology, Therapies and Trials

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2003

Clinical Pharmacology

Therapies

Trials

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.

Science

Science FDA Clinical Trials Pharmacy

Re-assessing the risks of drug-induced arrhythmias during drug discovery

Drug Discovery World

AUGUST 15, 2023

Specifically, we propose the hypothesis that whole-heart pacing studies are more likely than standard reductionist methods to recapitulate the biology of cardiac therapy (or toxicity) in human patients and hence have higher predictive validity than conventional methods. Journal of Cardiovascular Pharmacology, 20: S96-105 Aktas et al.

Drugs

Drugs Clinical Pharmacology Disease Engineering

Drug Discovery Digest

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Re-assessing the risks of drug-induced arrhythmias during drug discovery

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