The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance

Journal of Pharmaceutical Sciences

Volumn 103, Issue 11, 2014, Pages 3377-3397

  Selen, Arzu ^a   Dickinson, Paul A ^b   Müllertz, Anette ^c   Crison, John R ^d   Mistry, Hitesh B ^e   Cruañes, Maria T ^f   Martinez, Marilyn N ^a   Lennernäs, Hans ^g   Wigal, Tim L ^h   Swinney, David C ⁱ   Polli, James E ^j   Serajuddin, Abu T M ^k   Cook, Jack A ^l   Dressman, Jennifer B ^m  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b ASTRAZENECA   (United Kingdom)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d BRISTOL MYERS SQUIBB   (United States)

^e Physiomics PLC   (United Kingdom)

^f MERCK RESEARCH LABORATORIES   (United States)

^g UPPSALA UNIVERSITY   (Sweden)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ IRND3   (United States)

^j UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^k ST JOHN'S UNIVERSITY   (United States)

^l PFIZER INC   (United States)

^m GOETHE UNIVERSITY   (Germany)

more..

Author keywords

Bioavailability; Biopharmaceutics classification system (BCS); Clinical trial simulations; Controlled delivery; In silico modeling; In vitro models; In vitro in vivo correlations (IVIVC); Oral drug delivery; Pharmacodynamics; Pharmacokinetics; Quality by Design (QbD)

Indexed keywords

PRODRUG; DELAYED RELEASE FORMULATION; DRUG; DRUG CARRIER;

BIOPHARMACEUTICS RISK ASSESSMENT ROADMAP; CLINICAL DECISION MAKING; COMPUTER MODEL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG SCREENING; HUMAN; MEDICAL SOCIETY; NOTE; OUTCOME ASSESSMENT; PHARMACEUTICS; PHARMACIST; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; PROFESSIONAL KNOWLEDGE; RISK ASSESSMENT; SIMULATION; ANIMAL; CHEMISTRY; COMPUTER SIMULATION; DELAYED RELEASE FORMULATION; DRUG DEVELOPMENT; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; MEDICINAL CHEMISTRY; PHARMACOKINETICS; PROCEDURES; QUALITY CONTROL; RISK FACTOR; STANDARDS; THEORETICAL MODEL; TOXICITY TESTING;

ANIMALS; BIOPHARMACEUTICS; CHEMISTRY, PHARMACEUTICAL; COMPUTER SIMULATION; DELAYED-ACTION PREPARATIONS; DRUG CARRIERS; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; MODELS, THEORETICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; QUALITY CONTROL; RISK ASSESSMENT; RISK FACTORS; TOXICITY TESTS;

EID: 84915758373     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24162     Document Type: Note

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