A comparison of the prediction accuracy of two IVIVC modelling techniques

Journal of Pharmaceutical Sciences

Volumn 97, Issue 8, 2008, Pages 3422-3432

  Gaynor, Clare ^a   Dunne, Adrian ^a   Davis, John ^b  

^a UNIVERSITY COLLEGE DUBLIN   (Ireland)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Convolution; Deconvolution; In vitro in vivo correlations (IVIVC); Mathematical model

Indexed keywords

ACCURACY; ARTICLE; COMPUTER SIMULATION; CORRELATIONAL STUDY; DISSOLUTION; DRUG INFORMATION; FOOD AND DRUG ADMINISTRATION; IN VITRO STUDY; MATHEMATICAL ANALYSIS; VALIDATION STUDY;

EID: 52449110507     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21220     Document Type: Article

References (18)

1. Food and Drug Administration. 1997. Guidance for industry: Extended release oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations.
2. Dunne A, Gaynor C, Davis J. 2005. Deconvolution based approach for level A in vivo-in vitro correlation modelling: Statistical considerations. Clin Res Regul Aff 22:1-14.
3. O'Hara T, Hayes S, Davis J, Devane J, Smart T, Dunne A. 2001. In vivo-in vitro correlation (IVTVC) modeling incorporating a convolution step. J Phar-macokinet Pharmacodyn 28:277-298.
4. Dunne A. 2007. Approaches to developing in vitro-in vivo correlation models. In: Chilukuri DM, Sunkara G, Young D, editors. Pharmaceutical product development in vitro-in vivo correlation. pp 47-70.
5. Madden FN, Godfrey KR, Chappell MJ, Hovorka R, Bates RA. 1996. A comparison of six deconvolution techniques. J Pharmacokinet Biopharm 24:283-299.
6. Abuzarur-Aloul R, Gjellan K, Sjölund M, Löfqvist M, Graffner C. 1997. Critical dissolution tests of oral systems based on statistically designed experiments. I. Screening of critical fluids and in vitro/in vivo modelling of extended release coated spheres. Drug Dev Ind Pharm 23:749-760.
7. Abuzarur-Aloul R, Gjellan K, Sjolund M, Graffner C. 1998. Critical dissolution tests of oral systems based on statistically designed experiments. II. In vitro optimization of screened variables on ER-coated spheres for the establishment of an in vitro/in vivo correlation. Drug Dev Ind Pharm 24:203-212.
8. Abuzarur-Aloul R, Gjellan K, Sjolund M, Graffner C. 1998. Critical dissolution tests of oral systems based on statistically designed experiments. III. In vitro/in vivo correlation for multiple-unit capsules of paracetamol based on PLS modeling. Drug Dev Ind Pharm 24:371-383.
9. Liu Y, Schwartz JB, Schnaare RL, Sugita ET. 2003. A multi-mechanistic drug release approach in a bead dosage form and in vitro/in vivo correlations. Pharm Dev Technol 8:409-417.
10. Cardot JM, Beyssac E. 1993. In vitro/in vivo correlations: Scientific implications and standardisation. Eur J Drug Metab Pharmacokinet 18:113-120.
11. Kortejarvi H, Mikkola J, Bacjman M, Antila S, Marvola M. 2002. Development of level A, B and C in vitro-in vivo correlations for modified-release levosimendan capsules. Int J Pharm 241: 87-95.
12. Snedecor GW, Cochran WG. 1980. Statistical methods, 7th edition. Ames, Iowa: Iowa State University Press.
13. Wing GM. 1991. A primer on integral equations of the first kind - The problem of deconvolution and unfolding. Philadelphia: Society for Industrial and Applied Mathematics.
14. Beal SL, Sheiner LB. 1992. NONMEM user's guides, NONMEM Project Group. San Francisco: University of California.
15. Hovorka R, Chappell MJ, Godfrey KR, Madden FN, Rouse MK, Soons PA. 1998. CODE: A deconvolution program implementing a regularization method of deconvolution constrained to non-negative values. Description and pilot evaluation. Biopharm Drug Dispos 19:39-53.
16. Farrell C, Hayes S. 2007. IVIVC for oral drug delivery: Immediate and extended release dosage forms. In: Chilukuri DM, Sunkara G, Young D, editors. Pharmaceutical product development in vitro-in vivo correlation. pp 47-70.
17. Zhang L, Beal S, Sheiner L. 2003. Simultaneous vs. sequential analysis for population PK/PD data I: Best-case performance. Journal of Pharmacoki-netics and Pharmacodynamics 30:387-403.
18. Verbeke G, Molenberghs G. 2000. Linear mixed models for longitudinal data. New York: Springer.