Abstract
To minimize cost and development time, proactive strategies and plans must be in place before embarking on pharmaceutical product process improvements, formulation changes and line extensions. With escalating drug development costs and the need for reduced development times, there has been increasing awareness within the regulatory agencies as well as the industry, of the need to develop meaningful, discriminatory in vitro tests that will help to assure in vivo bioavailability / bioequivalence (BA/BE). Assessing the risk / benefit criteria and global regulatory requirements that may include human studies for formulation or chemistry changes is a key component when determining the ultimate benefit of contemplated product changes.
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References
CFR320.30. Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
FDA Guidance for industry. Bioavailability and bioequivalence studies for orally administered drug products - General considerations. 2000.
FDA Guidance for industry. Immediate release solid oral dosage forms. Scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. 1995
FDA Guidance for industry. Dissolution testing of immediate release solid oral dosage forms. 1997.
FDA Guidance for industry. SUPAC-MR: modified release solid oral dosage forms. Scale-up and postapproval changes: Chemistry, manufacturing, and controlsin vitrodissolution testing, andin vivobioequivalence documentation. 1997.
FDA Guidance for industry. Nonsterile semisolid dosage forms. Scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. 1997.
FDA Guidance for industry. Waiver ofin vivobioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. 2000.
FDA Draft guidance for industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. 2001
European Commission notice to applicants. A guideline on dossier requirements for type I variations. 1999.
Committee for Proprietary Medicinal Products (CPMP) Note for Guidance. The investigation of bioavailability and bioequivalence. 2001.
Therapeutic Goods Administration (Australia) Directive. Investigation of bioavailability and bioequivalence, 1992.
Australian guidelines for the registration of drugs. Changes to drug products-is notification or prior approval required ?1994
Therapeutic Products Directorate (Canada) Bioequivalence of proportional formulations. 1996.
Therapeutic Products Directorate (Canada) Preparation of drug submissions: Comparative bioavailability studies. 1997.
Ministry of Health, Welfare and Labor (Japan). Information on guideline for bioequivalence test on oral solid preparation for which the formulation has been changed, 2000.
G. L. Amidon, H. Lennemas, V.P. Shah, and J.R. Crison, A theoretical basis for a biopharmaceutic drug classification: The correlation ofin vitrodrug product dissolution andin vivobioavailabilityPharm. Res.12(3), 413–420 (1995).
FDA Guidance for Industry. Extended release oral dosage forms: Development, evaluation, and applications of invitro/in vivocorrelations, 1997.
CFR320.22. Criteria for waiver of evidence ofin vivobioavailability or bioequivalence.
CFR320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
R. Lobenberg and G.L. Amidon. Modem bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards. Eur. J. Pharm. Biopharm. 50(1), 5–12, 2000.
J. Mendell-Harary, J. Dowell, S. Bigora, D. Piscitelli, J. Butler, C. Farrell, J. Dveane, and D. Young, in:In vitro - in vivocorrelations, edited by D. Young, J.G. Devane, and J. Butler (Plenum Press, New York and Liindon, 1997).pp. 199–206.
G. Balan, P. timmins, D.S. Greene, and P.H. Marathe. In-vitro in-vivo correlation models for glibenclimide after administration of metformin/glibenclimide tablets to healthy human volunteers. J. Pharm. Pharmacol., 52: 831–838, 2000.
J. Posti, K. Katila, and T. Kostianen. Dissolution rate limited bioavailability of flutamide, andin vitro-in vivocorrelation. Eur. J. Pharmaceut. Biopharmaceut. 49: 35–39 (2000).
J. Radocanovic, Z. Duric, M. Jovanovic, S, Ibric, and M. Petrovic. An attempt to establish anin vitro - in vivocorrelation: case of immediate-release tablets. Eur. J. Drug Metab. Pharmacokin. 23(1) 3–40 (1998).
O.A. Lake, M. Oiling, andD.M. Barends.In vitro/in vivocorrelations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers. Eur. J. Pharmacokin. Biopharmaceut. 18: 13–19 (1999).
J. E. Polli, in:In vitro — in vivocorrelations, edited by D. Young, J.G. Devane, and J. Butler (Plenum Press, New York and London, 1997) pp 191–918.
C.A.S. Bergstrom, U. Norinder, K. Luthman, and P. Artursson. Experimental and computational screening models for prediction of aqueous drug solubility. Phar. Res. 19(2) 182–188, 2002.
E.S. Kostewicz, U. Braums, R. Becker, and J.B. Dressman. Forecasting the oral absorption behavior or poorly soluble weak bases using solubility and dissolution studies in biorelevant media. Pharm. Res., 19(3) 345–349 (2002).
B. Agoram, W.S. WoltoszM.B.Bolger. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv. Drg. Del. Rev. 50: S41–S67 (2001).
K.A. Lentz, J. HayashiL.J.Lucsiano, and J.E. Polli. Development of a more rapid, reduced serum culture system for Caco-2 monolayers and application to the biopharmaceutics classification system. Int. j. Pharmaceut. 200; 41–51 (2000).
J. B. Dressman and C. Reppas.In vitro-in vivocorrelations for lipophilic, poorly water-soluble compounds. Eur. J. Pharm. Sci., 11(suppl.2): S73–S80 (2000).
J. Jinno, D-M Oh, J.R. Crison, and G.L.Amidon. Dissolution of ionizable water-insoluble drugs: The combined effect of pH and surfactant. J. Pharmaceut. Sci., 89(2) 268–274, 2000.
M.J. Ginski, R. Taneja, and J.E. Polli. Prediction of dissolution-absorption relationships from a continuous dissolution/Caco-2 system. AAPS Pharm.Sci. 1(3): 1–12 (1999).
L.X. Yu, C.D. Ellison, D.P. Connor, L.J. Lesko, and A.S. Hussain. Influence of drug release properties of conventional solid dosage forms on the systemic exposure of highly soluble drugs. AAPS Pharm. Sci 3(3): 1–7 (2001).
L.X. Yu, J.T. Wang, and A.S. Hussain. Evaluation of USP Apparatus 3 for dissolution testing of immediate-release products. AAPS Pharm. Sci. 4(1): 1–5 (2002).
L.X. Yu, G.L. Amidon, J.E. Polli, H. Zhao, M.U. Mehta, D.P. Conner, V.P. Shah, L.J. Lesko, M-L Chen, V.H.L. Lee, and A.S. Hussain. Biopharmaceutics Classification System: The scientific basis for biowaiver extensions. Pharm. Res. 19(7): 921–925, 2002.
FDA Draft guidance for industry. Bioavailability and bioequivalence studies for orally administered drug products - General considerations, 2002.
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Gupta, E., Yamashita, E. (2004). Global Regulatory And Biopharmaceutics Strategies In New Drug Development: Biowaivers. In: Krishna, R. (eds) Applications of Pharmacokinetic Principles in Drug Development. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-9216-1_8
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