Assessing the risk of pH-dependent absorption for new molecular entities: A novel in vitro dissolution test, physicochemical analysis, and risk assessment strategy

Molecular Pharmaceutics

Volumn 10, Issue 11, 2013, Pages 4063-4073

  Mathias, Neil R ^a   Xu, Yan ^a   Patel, Dhaval ^a   Grass, Michael ^b   Caldwell, Brett ^b   Jager, Casey ^b   Mullin, Jim ^b   Hansen, Luke ^b   Crison, John ^a   Saari, Amy ^a   Gesenberg, Christoph ^a   Morrison, John ^a   Vig, Balvinder ^a   Raghavan, Krishnaswamy ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b Bend Research Incorporated   (United States)

Author keywords

achlorhydria; dissolution; in vitro in vivo correlation; pH effect; physicochemical properties; precipitation; risk assessment; supersaturation

Indexed keywords

ALBENDAZOLE; DARUNAVIR; DASATINIB; DELAVIRDINE; DIPYRIDAMOLE; ENOXACIN; ERLOTINIB; GEFITINIB; INDINAVIR; ITRACONAZOLE; KETOCONAZOLE; NELFINAVIR; NILOTINIB; POSACONAZOLE; PRASUGREL; PROPRANOLOL;

ACHLORHYDRIA; ARTICLE; COMPUTER MODEL; DRUG ABSORPTION; DRUG SOLUBILITY; HUMAN; IN VITRO STUDY; PARTIAL LEAST SQUARES REGRESSION; PH; PHYSICAL CHEMISTRY; PRECIPITATION; PRIORITY JOURNAL; RISK ASSESSMENT; STOMACH PH;

ABSORPTION; ACHLORHYDRIA; HUMANS; HYDROGEN-ION CONCENTRATION; MODELS, THEORETICAL; RISK ASSESSMENT;

EID: 84887359667     PISSN: 15438384     EISSN: 15438392     Source Type: Journal    
DOI: 10.1021/mp400426f     Document Type: Article

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