Effective absorption modeling in relative bioavailability study risk assessment

AAPS Journal

Volumn 14, Issue 4, 2012, Pages 895-903

  Rose, John P ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Absorption modeling; Drug product; RBA study; Relative bioavailability study; Risk assessment

Indexed keywords

DRUG;

AREA UNDER THE CURVE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SOLUBILITY; MAXIMUM PLASMA CONCENTRATION; MODEL; PARTICLE SIZE; RELIABILITY; REVIEW; RISK ASSESSMENT; SIMULATION; TABLET; TIME TO MAXIMUM PLASMA CONCENTRATION;

BIOLOGICAL AVAILABILITY; DRUG DESIGN; HUMANS; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT;

EID: 84869123132     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9402-1     Document Type: Review

References (5)

1. Amidon GL, Lennernas H, Shah VP, Crison Jr. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo. Pharm Res. 1995;12:413-20.
2. Gao Y, Carr R, Spence J, Wang W, Turner T, Lipari J, et al. A pH-dilution method for estimation of biorelevant drug solubility along the gastrointestinal tract: application to physiologically based pharmacokinetic modeling. Mol Pharm. 2010;7:1516-26.
3. Sheridan R, Feuston B, Maiorov V, Kearsley S. Similarity to molecules in the training set is a good discriminator for prediction accuracy in QSAR. J Chem Inf Comput Sci. 2004;44:1912-28.
4. SUPAC-MR:Modified release solid oral dosage forms: scale up and post-Approval changes: chemistry, manufacturing, and controls; in vitro dissolution testing and in vivo bioequivalence documentation; United States Food and Drug Administration: Rockville, 1997.
5. Ding X, Rose J, Van Gelder J. Developability assessment of clinical drug products with maximum absorbable doses. Int J Pharm. 2012;427:260-9.