API quality by design example from the torcetrapib manufacturing process

Journal of Pharmaceutical Innovation

Volumn 2, Issue 3-4, 2007, Pages 71-86

  am Ende, Dave ^a   Bronk, Karen S ^a   Mustakis, Jason ^a   O'Connor, Gary ^b   Santa Maria, Charles L ^a   Nosal, Roger ^a   Watson, Timothy J N ^a  

^a PFIZER INC   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Active pharmaceutical ingredient; Control strategy; Criticality; Design space; Quality by Design (QbD); Risk assessment; Torcetrapib API

Indexed keywords

TORCETRAPIB;

ARTICLE; DRUG DESIGN; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROCESS CONTROL; PRODUCT DEVELOPMENT; QUALITY CONTROL; RISK ASSESSMENT;

EID: 38349082679     PISSN: 18725120     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12247-007-9015-x     Document Type: Article

References (2)

1. Damon DB, Dugger RW, Magnus-Aryitey G, Ruggeri RB, Wester RT, Tu M, Abramov Y. Synthesis of the CETR inhibitor Torcetrapib: The resolution route and origin of stereoselectivity in the iminium ion cyclization. Org Process Res Dev 2006;103:464-71.
2. Damon DB, Dugger RW, Hubbs SE, Scott JM, Scott RW. Asymmetric synthesis of the cholesteryl ester transfer protein inhibitor torcetrapib. Org Process Res Dev 2006;103:472-80.