Drug Product Development: A Technical Review of Chemistry, Manufacturing, and Controls Information for the Support of Pharmaceutical Compound Licensing Activities

Drug Development and Industrial Pharmacy

Volumn 29, Issue 9, 2003, Pages 939-958

  DiFeo, Thomas J ^a  

^a J/Johnson Pharmaceut Res/Devmt   (United States)

Author keywords

CMC; Common technical document; Drug development; Drug product; Licensing

Indexed keywords

AMINE; AMOXICILLIN; ANTIOXIDANT; ASCORBIC ACID; BENZOIC ACID ESTER DERIVATIVE; BENZYL ALCOHOL; BUFFER; BULKING AGENT; CARBOHYDRATE; CHELATING AGENT; CYCLODEXTRIN DERIVATIVE; DRUG; ENDOTOXIN; ETHYL CELLULOSE; EXCIPIENT; GLUCOSE; GUAIACOL; HYDROGEN; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; MAGNESIUM STEARATE; MALTOSE; OXYGEN; POVIDONE; PRESERVATIVE; SODIUM METABISULFITE; SOLVENT; SULFITE; THICKENING AGENT; THIOMERSAL;

CHEMISTRY; CHROMATOGRAPHY; CONTAINER; DIFFERENTIAL SCANNING CALORIMETRY; DOCUMENTATION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DEVELOPMENT; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG STABILITY; FREEZE DRYING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROGEN BOND; INFRARED SPECTROSCOPY; LEGAL ASPECT; LICENSING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; METHODOLOGY; OXIDATION; PARTICLE SIZE; PH; PHARMACEUTICS; PHYSICAL CHEMISTRY; REPRODUCIBILITY; REVIEW; RISK ASSESSMENT; STANDARD; THERMAL ANALYSIS; THERMOGRAVIMETRY; ULTRAVIOLET SPECTROSCOPY; VALIDATION PROCESS; X RAY POWDER DIFFRACTION;

CHEMISTRY, PHARMACEUTICAL; DOSAGE FORMS; TECHNOLOGY, PHARMACEUTICAL;

EID: 0242353026     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.1081/DDC-120025452     Document Type: Review

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