Dissolution specifications based on release rates

Journal of Pharmaceutical Sciences

Volumn 88, Issue 4, 1999, Pages 434-444

  Elkoshi, Zeev ^a  

^a TEVA PHARMACEUTICALS   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; COMPARTMENT MODEL; CONTROLLED DRUG RELEASE; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISPOSITION; DRUG FORMULATION; DRUG SOLUBILITY;

EID: 0344019460     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js980322p     Document Type: Article

References (7)

1. Guidance for Industry, Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations. CDER, Food and Drug Administration, USA, 1997.
2. The United States Pharmacopeia (USP 23); United States Pharmacopeial Convention: Rockville, MD, 1995; p 1929.
3. Frick, A.; Möller, H.; Wirbitzki, E. Biopharmaceutical characterization of oral controlled/modified-release drug products. In vitro/in vivo correlation of roxatidine. Eur. J. Pharm. Biopharm. 1998, 46, 313-319.
4. Gibaldi M.; Perrier. D. Pharmacokinetics, 2nd ed.; Marcel Dekker: New York and Basel, 1982.
5. Rostami-Hodjegan, A.; Jackson, P. R.; Tucker, G. T. Sensitivity of indirect metrics for assessing "rate" in bioequi valence studies-moving the "goalposts" or changing the "game". J. Pharm. Sci. 1994, 83, 1564-1556.
6. Grundy, J. S.; Foster, R. T. The nifedipine gastrointestinal therapeutic system (GITS): Evaluation of pharmaceutical, pharmacokinetic and pharmacological properties. Clin. Pharmacokinet. 1994, 30(1), 28-51.
7. Swanson, R. D., Barclay, B. L., Wong, P. S., Theeuwes, F. Nifedipine gastrointestinal therapeutic system. Am. J. Med. 1987, 83 (Suppl. 6B), 3-9.