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105 CPMP Note for Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98 Draft), Dec 1998 106 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 Classi cation System, CDERGUID\2062dftwpd Draft, Jan 1999 107 Blume, H H; Schug, B S, The biopharmaceitics classi cation system (BCS): Class III drugs better candidates for BA/BE waiver Eur J Pharm Sci 9, 117 121 (1999) 108 Lentz, K A; Hayashi, J; Lucisano, L J; Polli, J E, Development of a more rapid, reduced serum culture system for Caco-2 monolayers and application to the biopharmaceutics classi cation system, Int J Pharm 200, 41 51 (2000) 109 Chen, M-L; Shah, V; Patnaik, R; Adams, W; Hussain, A; Conner, D; Mehta, M; Malinowski, H; Lazor, J; Huang, S-M; Hare, D; Lesko, L; Sporn, D; Williams, R, Bioavailability and bioequivalence: an FDA regulatory overview, Pharm Res 18, 1645 1650 (2001) 110 Rege, B D; Yu, L X; Hussain, A S; Polli, J E, Effect of common excipients on Caco-2 transport of low-permeability drugs, J Pharm Sci 90, 1776 1786 (2001) 111 Ritschel, W A, in Fraske, D E; Whitney, H A K, Jr (eds), Perspectives in Clinical Pharmacy, Drug Intelligence Publications, Hamilton, IL, 1972, pp 325 367 112 Avdeef, A, Applications and Theory Guide to pH-Metric pKa and log P Measurement, Sirius Analytical Instruments Ltd Forest Row, UK, 1993 113 Levy, R H; Rowland, M, Dissociation constants of sparingly soluble substances: nonlogarithmic linear titration curves, J Pharm Sci 60, 1155 1159 (1971) 114 Purdie, N; Thomson, M B; Riemann, N, The thermodynamics of ionization of polycarboxylic acids, J Solut Chem 1, 465 476 (1972) 115 Streng, W H; Steward, D L, Jr, Ionization constants of an amino acid as a function of temperature, Int J Pharm 61, 265 266 (1990) 116 Avdeef, A; Bucher, J J, Accurate measurements of the concentration of hydrogen ions with a glass electrode: Calibrations using the Prideaux and other universal buffer solutions and a computer-controlled automatic titrator, Anal Chem 50, 2137 2142 (1978) 117 Avdeef, A, Weighting scheme for regression analysis using pH data from acid-base titrations, Anal Chim Acta 148, 237 244 (1983) 118 Avdeef, A, STBLTY: Methods for construction and re nement of equilibrium models, in Leggett, D J (ed), Computational Methods for the Determination of Formation Constants, Plenum Press, New York, 1985, pp 355 473 119 Avdeef, A; Comer, J E A; Thomson, S J, pH-metric logP 3 Glass electrode calibration in methanol-water, applied to pKa determination of water-insoluble substances, Anal Chem 65, 42 49 (1993) 120 Lingane, P J; Hugus, Z Z Jr, Normal equations for the gaussian least-squares re nement of formation constants with simultaneous adjustment of the spectra of the absorbing species, Inorg Chem 9, 757 762 (1970) 121 Hugus, Z Z, Jr; El-Awady, A A, The determination of the number of species present in a system: A new matrix rank treatment of spectrophotometric data, J Phys Chem 75, 2954 2957 (1971)
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