Enantiomeric drug development: Issues, considerations, and regulatory requirements

Journal of Pharmaceutical Sciences

Volumn 90, Issue 9, 2001, Pages 1205-1215

  Srinivas, Nuggehally R ^a   Barbhaiya, Rashmi H ^a   Midha, Kamal K ^b  

^a BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF SASKATCHEWAN   (Canada)

Author keywords

Chirality; Enantiomeric drug development; Enantiomers; NDA; Regulatory requirements for enantiomers; Strategies for chiral drugs

Indexed keywords

BENOXAPROFEN; KETAMINE; METHYLPHENIDATE; MOGUISTEINE; QUINOLINE DERIVATIVE; TERODILINE; WARFARIN;

CHIRALITY; DRUG APPROVAL; DRUG FORMULATION; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; DRUG SYNTHESIS; ENANTIOMER; RACEMIC MIXTURE; SHORT SURVEY; STEREOISOMERISM;

EID: 0034820056     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.1074     Document Type: Article

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