An automated process for building reliable and optimal in vitro/in vivo correlation models based on Monte Carlo simulations

AAPS Journal

Volumn 8, Issue 2, 2006, Pages

  Sutton, Steven C ^a   Hu, Mingxia ^b  

^a PFIZER INC   (United States)

^b MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

Gompertz; Higuchi; Hixson Crowell; IVIVC models; Linear; Logistic; Mitcherlich; Monte Carlo simulations; Sigmoid; Weibull

Indexed keywords

CELLULOSE ACETATE; ETHYL CELLULOSE; HYDROXYPROPYLCELLULOSE; MACROGOL; MAGNESIUM STEARATE; MICROCRYSTALLINE CELLULOSE; PSEUDOEPHEDRINE;

ADULT; ANALYTICAL ERROR; AREA UNDER THE CURVE; ARTICLE; AUTOMATION; CLINICAL TRIAL; COMPUTER PREDICTION; COMPUTER PROGRAM; COMPUTER SIMULATION; CONTROLLED RELEASE FORMULATION; CORRELATION ANALYSIS; DATA BASE; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; IN VIVO STUDY; INTERMETHOD COMPARISON; LINEAR SYSTEM; MALE; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; MATRIX TABLET; MONTE CARLO METHOD; NORMAL HUMAN; PHYSICAL CHEMISTRY; PROBABILITY; RELIABILITY; STATISTICAL MODEL; STATISTICS; SUSTAINED DRUG RELEASE;

AUTOMATION; COMPUTER SIMULATION; MODELS, THEORETICAL; MONTE CARLO METHOD; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; SOLUBILITY;

EID: 33646766469     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj080535     Document Type: Article

References (18)

1. McClelland GA, Sutton SC, Engle K, Zentner GM. The solubility modulated osmotic pump: in vitro/in vivo release of diltiazem hydrochloride. Pharm Res. 1991;8:88-92.
2. Sunesen VH, Pedersen BL, Kristensen HG, Mullertz A. In vivo in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media. Eur J Pharm Sci. 2005;24:305-313.
3. Cheung RY, Kuba R, Rauth AM, Wu XY. A new approach to the in vivo and in vitro investigation of drug release from locoregionally delivered microspheres. J Control Release. 2004;100:121-133.
4. Liu Y, Schwartz JB, Schnaare RL, Sugita ET. A multi-mechanistic drug release approach in a bead dosage form and in vitro/in vivo correlations. Pharm Dev Technol. 2003;8:409-417.
5. FDA. FDA Guidance for Industry. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System. Rockville, MDFDA. 2000; Available at: http://www.fda.gov/cder/guidance/index.htm. Accessed April 11, 2005.
6. Gillespie W. Convolution-based approaches for in vitro in vivo correlation modeling. In: Young D, Devane J, Butler J, eds. In Vitro in Vivo Correlations. Vol 423. New York, NY: Plenum Press; 1997:53-65.
7. Pitsiu M, Sathyan G, Gupta S, Verotta D. A semiparametric deconvolution model to establish in vivo-in vitro correlation applied to OROS oxybutynin. J Pharm Sci. 2001;90:702-712.
8. Buchwald P. Direct, differential-equation-based in-vitro-in-vivo correlation (IVIVC) method. J Pharm Pharmacol. 2003;55: 495-504.
9. Gillespie WR. Convolution-based approaches for in vivo-in vitro correlation modeling. Adv Exp Med Biol. 1997;423:53-65.
10. Veng-Pedersen P, Gobburu JV, Meyer MC, Straughn AB. Carbamazepine level-A in vivo-in vitro correlation (IVIVC): a scaled convolution based predictive approach. Biopharm Drug Dispos. 2000;21:1-6.
11. Mendell-Harary J, Dowell J, Bigora S. Nonlinear in vitro-in vivo correlations. In: Young D, Devane J, Butler J, eds. Vol 423. In Vitro-In. Vivo Correlations. New York, NY: Plenum Press; 1997:199-206.
12. Thombre AG, Cardinal JR, DeNoto AR, Herbig SM, Smith KL. Asymmetric membrane capsules for osmotic drug delivery. I. Development of a manufacturing process. J Control Release. 1999;57:55-64.
13. Mano T, Stevens RW, Ando K, et al. Novel imidazole compounds as a new series of potent, orally active inhibitors of 5-lipoxygenase. Bioorg Med Chem. 2003;11:3879-3887.
14. Marquardt D. An algorithm for least-squares estimation of nonlinear parameters. SIAM J Appl Math. 1963;11:431-441.
15. Tzeng TB, Fung HL. Pharmacodynamic modeling of the in vitro vasodilating effects of organic mononitrates. J Pharmacokinet Biopharm. 1992;20:227-251.
16. Akaike H. Information theory and the extension of the maximum likelihood principle. Proceedings of the Second International Symposium on Information Theory; 1973; Budapest Akailseoniai-Kiudo: Budapest: Akailseoniai-Kiudo; 1973: 267-281.
17. Kullback S. Information Theory and Statistics New York, NY: Dover Publications; 1968.
18. Hurvich C, Tsai C-L. Regression and Time Series Model Selection in Small Samples. Biometrika. 1989;76:297-307.