496
N. Ya. Golovenko et al.
algorithms of model development, (2) expand the training sets which are used for
model development by novel experimental data. We believe that the usage of in
silico modeling for prediction of pharmacokinetic properties will be boosted by the
recent explosion of chemogenomics and other types of data.
References
1. Amidon GL, Lennernas H, Shah VP et al (1995) A theoretical basis for a biopharmaceutics
drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413–420
2. Golovenko NYa, Baula OP, Borisyuk IYu (2010) Biofarmatsevticheskaya klassifikatsionnaya
sistema (The biopharmaceutics classification system). Kiev
3. Sachan NK (2009) Biopharmaceutical classification system: a strategic tool for oral drug
delivery technology. Asian J Pharm 3:76–81
4. Dressman J, Butler J, Hempenstall J et al (2001) The BCS: where do we go from here? Pharm
Tech 25:68–76
5. Thiel-Demby VE, Humphreys JE, Williams LA et al (2009) Biopharmaceutics classification
system: validation and learnings of an in vitro permeability assay. Mol Pharm 6:11–18
6. Kovacevic I, Parojcic J, Homsek I et al (2009) Justification of biowaiver for carbamazepine,
a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation. Mol Pharm 6:40–47
7. FDA, Draft guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general considerations, US Department of Health, Food and Drug
Administration, Center for Drug Evaluation and Research BP, August 1999
8. Golovenko NYa (2004) Fiziko-khimicheskaya farmakologiya (Physico-Chemical Pharmacology). Astroprint, Odessa
9. van de Waterbeemd H (2003) Physico-chemical approaches to drug absorption. In: van de
Waterbeemd H, Lennernas H, Artursson P (eds) Drug bioavailability: estimation of solubility,
permeability, absorption and bioavailability. Wiley-VCH, pp 3–20
10. Martinez M, Amidon GA (2002) Mechanistic approach to understanding the factors affecting
drug absorption: a review of fundamentals. J Clin Pharmacol 42:620–643
11. Barthe L, Woodley J, Houin G (1999) Gastrointestinal absorption of drugs: methods and studies. Fundam Clin Pharmacol 13:154–168
12. Hidalgo IJ, Li J (1996) Carrier-mediated transport and efflux mechanisms in Caco-2 cells.
Adv Drug Deliv Rev 22:53–66
13. Lobenberg R, Amidon GL (2000) Modern bioavailability, bioequivalence and biopharmaceutics classification system: new scientific approaches to international regulatory standards. Eur
J Pharm Biopharm 50:3–12
14. Emami J (2006) In vitro-in vivo correlation: from theory to applications. J Pharm Pharm Sci
9(2):31–51
15. Golovenko NYa, Borisyuk IYu (2008) The biopharmaceutical classification system-experimental model of prediction of drug bioavailability. Biochem Suppl Series B: Biomed Chem
2(3):235–244
16. EMEA (1998) Note for guidance on the investigation of bioavailability and bioequivalence,
(CPMP/EWP/QWP/1401/98), Committee for proprietary medicinal product
17. FDA, Draft guidance for industry: in vivo drug metabolism/drug interaction studies study design, data analysis, and recommendations for dosing and labeling, US Department of Health,
Food and Drug Administration, Center for Drug Evaluation and Research Clin Pharm, November 1998
N. Ya. Golovenko et al.
algorithms of model development, (2) expand the training sets which are used for
model development by novel experimental data. We believe that the usage of in
silico modeling for prediction of pharmacokinetic properties will be boosted by the
recent explosion of chemogenomics and other types of data.
References
1. Amidon GL, Lennernas H, Shah VP et al (1995) A theoretical basis for a biopharmaceutics
drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413–420
2. Golovenko NYa, Baula OP, Borisyuk IYu (2010) Biofarmatsevticheskaya klassifikatsionnaya
sistema (The biopharmaceutics classification system). Kiev
3. Sachan NK (2009) Biopharmaceutical classification system: a strategic tool for oral drug
delivery technology. Asian J Pharm 3:76–81
4. Dressman J, Butler J, Hempenstall J et al (2001) The BCS: where do we go from here? Pharm
Tech 25:68–76
5. Thiel-Demby VE, Humphreys JE, Williams LA et al (2009) Biopharmaceutics classification
system: validation and learnings of an in vitro permeability assay. Mol Pharm 6:11–18
6. Kovacevic I, Parojcic J, Homsek I et al (2009) Justification of biowaiver for carbamazepine,
a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation. Mol Pharm 6:40–47
7. FDA, Draft guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general considerations, US Department of Health, Food and Drug
Administration, Center for Drug Evaluation and Research BP, August 1999
8. Golovenko NYa (2004) Fiziko-khimicheskaya farmakologiya (Physico-Chemical Pharmacology). Astroprint, Odessa
9. van de Waterbeemd H (2003) Physico-chemical approaches to drug absorption. In: van de
Waterbeemd H, Lennernas H, Artursson P (eds) Drug bioavailability: estimation of solubility,
permeability, absorption and bioavailability. Wiley-VCH, pp 3–20
10. Martinez M, Amidon GA (2002) Mechanistic approach to understanding the factors affecting
drug absorption: a review of fundamentals. J Clin Pharmacol 42:620–643
11. Barthe L, Woodley J, Houin G (1999) Gastrointestinal absorption of drugs: methods and studies. Fundam Clin Pharmacol 13:154–168
12. Hidalgo IJ, Li J (1996) Carrier-mediated transport and efflux mechanisms in Caco-2 cells.
Adv Drug Deliv Rev 22:53–66
13. Lobenberg R, Amidon GL (2000) Modern bioavailability, bioequivalence and biopharmaceutics classification system: new scientific approaches to international regulatory standards. Eur
J Pharm Biopharm 50:3–12
14. Emami J (2006) In vitro-in vivo correlation: from theory to applications. J Pharm Pharm Sci
9(2):31–51
15. Golovenko NYa, Borisyuk IYu (2008) The biopharmaceutical classification system-experimental model of prediction of drug bioavailability. Biochem Suppl Series B: Biomed Chem
2(3):235–244
16. EMEA (1998) Note for guidance on the investigation of bioavailability and bioequivalence,
(CPMP/EWP/QWP/1401/98), Committee for proprietary medicinal product
17. FDA, Draft guidance for industry: in vivo drug metabolism/drug interaction studies study design, data analysis, and recommendations for dosing and labeling, US Department of Health,
Food and Drug Administration, Center for Drug Evaluation and Research Clin Pharm, November 1998