Quality risk management in pharmaceutical development

Drug Development and Industrial Pharmacy

Volumn 39, Issue 7, 2013, Pages 947-960

  Charoo, Naseem Ahmad ^a   Ali, Areeg Anwer ^b  

^a Blue Nile Pharmaceutical Factory   (Sudan)

^b RAK MEDICAL AND HEALTH SCIENCES UNIVERSITY   (United Arab Emirates)

Author keywords

Control strategy; Critical process parameters; Critical quality attributes; Design space; Pharmaceutical development; Quality by design; Quality risk management

Indexed keywords

1,1,1 TRICHLOROETHANE; 1,2 DICHLOROETHANE; BENZENE; CARBON TETRACHLORIDE; DISINTEGRATING AGENT; LACTOSE; LUBRICATING AGENT; MAGNESIUM STEARATE; MANNITOL; MICROCRYSTALLINE CELLULOSE; POVIDONE; STARCH; STARCH GLYCOLATE SODIUM; VINYLIDENE CHLORIDE;

BRAINSTORMING; CHECKLIST; COMPUTATIONAL FLUID DYNAMICS; CONTINUOUS PROCESS; DECISION MAKING; DELPHI STUDY; DOCUMENTATION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG COATING; DRUG DEGRADATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SOLUBILITY; EXCIPIENT COMPATIBILITY; INFORMATION DISSEMINATION; INTERVIEW; PARTICLE SIZE; PH; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PRODUCT DEVELOPMENT; QUESTIONNAIRE; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; RISK REDUCTION; SURFACE PROPERTY; TOTAL QUALITY MANAGEMENT; WORKSHOP;

CHEMISTRY, PHARMACEUTICAL; DRUG DISCOVERY; HUMANS; RESEARCH DESIGN; RISK ASSESSMENT; RISK MANAGEMENT;

EID: 84878829567     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2012.699065     Document Type: Review

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