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 40

Science FDA Clinical Trials Clinical Pharmacology 40

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). link] [13] A user’s guide to lorlatinib. Nagasaka et al.,

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). link] [13] A user’s guide to lorlatinib. Nagasaka et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52