-
1
-
-
85013756402
-
-
USA, Elsevier Inc
-
Qiu Y, Chen Y, Liu L, Zhang G. Developing solid oral dosage forms: pharmaceutical theory and practice. USA, Elsevier Inc. 2009; 341-360.
-
(2009)
Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice
, pp. 341-360
-
-
Qiu, Y.1
Chen, Y.2
Liu, L.3
Zhang, G.4
-
2
-
-
0028948839
-
A theoretical basis for a biopharmaceutical drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
-
Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutical drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res, 1995; 12: 413-420.
-
(1995)
Pharm Res
, vol.12
, pp. 413-420
-
-
Amidon, G.L.1
Lennernas, H.2
Shah, V.P.3
Crison, J.R.4
-
3
-
-
53849122291
-
Application of the biopharmaceutical classification system in clinical drug development--an industrial view
-
Cook J, Addicks W, Wu YH. Application of the biopharmaceutical classification system in clinical drug development--an industrial view. AAPS J, 2008; 10: 306-310.
-
(2008)
AAPS J
, vol.10
, pp. 306-310
-
-
Cook, J.1
Addicks, W.2
Wu, Y.H.3
-
4
-
-
53849085797
-
In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms
-
Polli JE. In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms. AAPS J, 2008; 10: 289-299.
-
(2008)
AAPS J
, vol.10
, pp. 289-299
-
-
Polli, J.E.1
-
5
-
-
3242728351
-
Molecular properties of WHO essential drugs and provisional biopharmaceutical classification
-
Kasim NA, Whitehouse M, Ramachandran C, Bermejo M, Lennernas H, Hussain AS, Junginger HE, Stavchansky SA, Midha KK, Shah VP, Amidon GL. Molecular properties of WHO essential drugs and provisional biopharmaceutical classification. Mol Pharm, 2004; 1: 85-96.
-
(2004)
Mol Pharm
, vol.1
, pp. 85-96
-
-
Kasim, N.A.1
Whitehouse, M.2
Ramachandran, C.3
Bermejo, M.4
Lennernas, H.5
Hussain, A.S.6
Junginger, H.E.7
Stavchansky, S.A.8
Midha, K.K.9
Shah, V.P.10
Amidon, G.L.11
-
6
-
-
0030914681
-
Polar molecular surface properties predict the intestinal absorption of drugs in humans
-
Palm K, Stenberg P, Luthman K, Artursson P. Polar molecular surface properties predict the intestinal absorption of drugs in humans. Pharm Res, 1997; 14: 568-571.
-
(1997)
Pharm Res
, vol.14
, pp. 568-571
-
-
Palm, K.1
Stenberg, P.2
Luthman, K.3
Artursson, P.4
-
7
-
-
79958174351
-
-
World Health Organization (WHO), (4th Revision), accessed on 14/12/2010
-
World Health Organization (WHO). National Essential Medicines List of Pakistan, 2007 (4th Revision) at http://apps.who.int/medicinedocs/fr/m/abstract/Js17119e/ accessed on 14/12/2010.
-
(2007)
National Essential Medicines List of Pakistan
-
-
-
8
-
-
56549096551
-
Committee for Proprietary Medicinal Products (CPMP)
-
The European Agency for the Evaluation of Medicinal Products (EMA)
-
The European Agency for the Evaluation of Medicinal Products (EMA), Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on the Investigation of Bioavailability and Bioequivalence. 2010.
-
(2010)
Note For Guidance On the Investigation of Bioavailability and Bioequivalence
-
-
-
10
-
-
84871212004
-
-
accessed on 14/12/2010
-
Drugbank database. http://www.drugbank.ca/ accessed on 14/12/2010.
-
Drugbank Database
-
-
-
11
-
-
0003856787
-
-
Syracuse Research Corporation, SRC Environmental Science Center. Syracuse, NY
-
Syracuse Research Corporation. Physical/Chemical Property Database (PHYSPROP). SRC Environmental Science Center. Syracuse, NY. 1994.
-
(1994)
Physical/Chemical Property Database (PHYSPROP)
-
-
-
13
-
-
3843097202
-
Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classifcation system
-
Lindenberg M, Kopp S, Dressman JB. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classifcation system. Eur J Pharm Biopharm, 2004; 58: 265-278.
-
(2004)
Eur J Pharm Biopharm
, vol.58
, pp. 265-278
-
-
Lindenberg, M.1
Kopp, S.2
Dressman, J.B.3
-
14
-
-
3242728351
-
Molecular properties of WHO essential drugs and provisional biopharmaceutical classifcation
-
Kasim NA, Whitehouse M, Ramachandran C, Bermejo M, Lennernas H, Hussain AS, Junginger HE, Stavchansky SA, Midha KK, Shah VP, Amidon GL. Molecular properties of WHO essential drugs and provisional biopharmaceutical classifcation. Mol Pharm, 2004; 1: 85-96.
-
(2004)
Mol Pharm
, vol.1
, pp. 85-96
-
-
Kasim, N.A.1
Whitehouse, M.2
Ramachandran, C.3
Bermejo, M.4
Lennernas, H.5
Hussain, A.S.6
Junginger, H.E.7
Stavchansky, S.A.8
Midha, K.K.9
Shah, V.P.10
Amidon, G.L.11
-
15
-
-
0348107338
-
Quantitative biopharmaceutics classifcation system: The central role of dose/solubility ratio
-
Rinaki E, Valsami G, Macheras P. Quantitative biopharmaceutics classifcation system: the central role of dose/solubility ratio. Pharm Res, 2003; 20: 1917-1925.
-
(2003)
Pharm Res
, vol.20
, pp. 1917-1925
-
-
Rinaki, E.1
Valsami, G.2
Macheras, P.3
-
16
-
-
79958113519
-
-
World Health Organization (WHO)
-
World Health Organization (WHO). Proposal to waive in vivo http://whqlibdoc.who.int/trs/WHO_TRS_ 937_eng.pdf.)
-
Proposal to Waive In Vivo
-
-
-
17
-
-
0032714220
-
Polar molecular surface as a dominating determinant for oral absorption and brain penetration of drugs
-
Kelder J, Grootenhuis PD, Bayada DM, Delbressine LP, Ploemen JP. Polar molecular surface as a dominating determinant for oral absorption and brain penetration of drugs. Pharm Res, 1999; 16: 1514-1519.
-
(1999)
Pharm Res
, vol.16
, pp. 1514-1519
-
-
Kelder, J.1
Grootenhuis, P.D.2
Bayada, D.M.3
Delbressine, L.P.4
Ploemen, J.P.5
-
18
-
-
84857004878
-
Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
-
Food and Drug Administration (FDA), CDER. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)., Ed. Rockville, MD
-
Food and Drug Administration (FDA), CDER. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Food and Drug Administration, Ed. Rockville, MD. 2000.
-
(2000)
Food and Drug Administration
-
-
-
19
-
-
70350174031
-
Drug Permeability Studies in Regulatory Biowaiver Applications
-
In: Ehrhardt C, Kim K, ed., Springer NY
-
Valope D. Drug Permeability Studies in Regulatory Biowaiver Applications. In: Ehrhardt C, Kim K, ed. Drug absorption studies: in situ, in vitro and in silico models. Springer NY 2008; 665-696.
-
(2008)
Drug Absorption Studies: In Situ, In Vitro and In Silico Models
, pp. 665-696
-
-
Valope, D.1
-
20
-
-
33745149302
-
Computational prediction of oral drug absorption based on absorption rate constants in humans
-
Linnankoski J, Makela JM, Ranta VP, Urtti A, Yliperttula M. Computational prediction of oral drug absorption based on absorption rate constants in humans. J Med Chem, 2006; 49: 3674-3681.
-
(2006)
J Med Chem
, vol.49
, pp. 3674-3681
-
-
Linnankoski, J.1
Makela, J.M.2
Ranta, V.P.3
Urtti, A.4
Yliperttula, M.5
-
21
-
-
0032585545
-
Evaluation of dynamic polar molecular surface area as predictor of drug absorption: Comparison with other computational and experimental predictors
-
Palm K, Luthman K, Ungell AL, Strandlund G, Beigi F, Lundahl P, Artursson P. Evaluation of dynamic polar molecular surface area as predictor of drug absorption: comparison with other computational and experimental predictors. J Med Chem, 1998; 41: 5382-5392.
-
(1998)
J Med Chem
, vol.41
, pp. 5382-5392
-
-
Palm, K.1
Luthman, K.2
Ungell, A.L.3
Strandlund, G.4
Beigi, F.5
Lundahl, P.6
Artursson, P.7
-
22
-
-
0032480901
-
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach
-
Winiwarter S, Bonham NM, Ax F, Hallberg A, Lennernas H, Karlen A. Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach. J Med Chem, 1998; 41: 4939-4949.
-
(1998)
J Med Chem
, vol.41
, pp. 4939-4949
-
-
Winiwarter, S.1
Bonham, N.M.2
Ax, F.3
Hallberg, A.4
Lennernas, H.5
Karlen, A.6
-
23
-
-
60749105377
-
Using measured pKa, LogP and solubility to investigate supersaturation and predict BCS class
-
Box KJ. Comer JE. Using measured pKa, LogP and solubility to investigate supersaturation and predict BCS class. Curr Drug Metab, 2008; 9: 869-878.
-
(2008)
Curr Drug Metab
, vol.9
, pp. 869-878
-
-
Box, K.J.1
Comer, J.E.2
-
24
-
-
77955921793
-
The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted
-
Benet LZ, Larregieu CA. The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted. Clin Pharmacol Ther, 2010; 88: 405-407.
-
(2010)
Clin Pharmacol Ther
, vol.88
, pp. 405-407
-
-
Benet, L.Z.1
Larregieu, C.A.2
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