Regulatory aspects of drug dissolution from a European perspective

European Journal of Pharmaceutical Sciences

Volumn 29, Issue 3-4 SPEC. ISS., 2006, Pages 288-293

  Graffner, Christina ^a  

^a MEDICAL PRODUCTS AGENCY   (Sweden)

Author keywords

Biowaivers; Dissolution test; In vitro in vivo correlation; Manufacturing control; Product development; Reference products; Regulatory aspects

Indexed keywords

IBUPROFEN; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PENICILLIN V POTASSIUM; PREDNISOLONE; TRANEXAMIC ACID;

BIOEQUIVALENCE; COMPARATIVE STUDY; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SAFETY; DRUG SOLUBILITY; HUMAN; PARTITION COEFFICIENT; PH; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; PROBABILITY; REVIEW; TABLET FORMULATION;

BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; DRUG AND NARCOTIC CONTROL; PHARMACEUTICAL PREPARATIONS; RESEARCH DESIGN; SOLUBILITY; THERAPEUTIC EQUIVALENCY;

EID: 33750146405     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2006.05.003     Document Type: Review

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