-
1
-
-
0028948839
-
A theoretical basis for a biopharmaceutics drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
-
Amidon GL, Lennernas H, Shah VP, and Crison JR, "A theoretical basis for a biopharmaceutics 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
-
2
-
-
77957602668
-
Waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a biopharmaceutics classification system
-
Guidance for industry, August
-
Guidance for industry, "Waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a biopharmaceutics classification system," CDER/FDA, August 2000.
-
(2000)
CDER/FDA
-
-
-
3
-
-
77957552713
-
Biopharmaceutics Classification System Guidance Office of Pharmaceutical Science
-
August
-
Biopharmaceutics Classification System Guidance Office of Pharmaceutical Science, CDER/FDA, August 2006.
-
(2006)
CDER/FDA
-
-
-
4
-
-
0034916430
-
The BCS: Where do we go from here
-
Dressman J, Butler J, Hempenstall J, Peppas C, "The BCS: where do we go from here," Pharmaceutical Technology., 2001, 68-76.
-
(2001)
Pharmaceutical Technology
, pp. 68-76
-
-
Dressman, J.1
Butler, J.2
Hempenstall, J.3
Peppas, C.4
-
5
-
-
0027473738
-
Estimating the fraction dose absorbed from the suspensions of poorly soluble compounds in humans: A mathematical model
-
Amidon GL et al, "Estimating the fraction dose absorbed from the suspensions of poorly soluble compounds in humans: a mathematical model," Pharm Res., 1993 10(3), 264-270.
-
(1993)
Pharm Res.
, vol.10
, Issue.3
, pp. 264-270
-
-
Amidon, G.L.1
et al2
-
6
-
-
0031913402
-
Dissolution testing as a prognostic tool for oral drug absorption: Immediate release dosage forms
-
Dressman JB, Amidon GL, Reppas C, Shah VP, "Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms," Pharm Res., 1998 15(1): 11-22.
-
(1998)
Pharm Res.
, vol.15
, Issue.1
, pp. 11-22
-
-
Dressman, J.B.1
Amidon, G.L.2
Reppas, C.3
Shah, V.P.4
-
7
-
-
0028948839
-
A theoretical basis for a biopharmaceutic 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 biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability," Pharm. Res., 1995, 12(3), 413-419.
-
(1995)
Pharm. Res.
, vol.12
, Issue.3
, pp. 413-419
-
-
Amidon, G.L.1
Lennernas, H.2
Shah, V.P.3
Crison, J.R.4
-
9
-
-
0030873847
-
The impact of in vitro-in vivo relationships on product development
-
Devane J, and Butler J, "The impact of in vitro-in vivo relationships on product development," Pharm. Tech., 1997, 21(9): 146-159.
-
(1997)
Pharm. Tech.
, vol.21
, Issue.9
, pp. 146-159
-
-
Devane, J.1
Butler, J.2
-
10
-
-
33745616771
-
In vitro - in vivo correlation: From theory to applications
-
Emami J, "In vitro - in vivo correlation: From theory to applications," J. Pharm. Pharmaceut. Sci., 2006, 9(2): 169-189.
-
(2006)
J. Pharm. Pharmaceut. Sci.
, vol.9
, Issue.2
, pp. 169-189
-
-
Emami, J.1
-
11
-
-
77957567822
-
Waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms containing certain active moieties/active ingredients based on biopharmaceutics classification system
-
Guidance for Industry, August
-
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 biopharmaceutics classification system," FDA, August 1999.
-
(1999)
FDA
-
-
-
12
-
-
77957567503
-
-
3rd Edition, Pharmaceu tech inc, Informa Healthcare USA
-
Swarbrick J, "Encyclopedia of pharmaceutical technology", Vol III, 3rd Edition, Pharmaceu tech inc, Informa Healthcare USA, 2007, 2049-2062.
-
(2007)
Encyclopedia of pharmaceutical technology
, vol.3
, pp. 2049-2062
-
-
Swarbrick, J.1
-
14
-
-
77957556929
-
Biopharmaceutical classification system and its importance
-
March
-
Khar RK, Pandita D, "Biopharmaceutical classification system and its importance," The Indian Pharmacist. March 2005, 25- 30.
-
(2005)
The Indian Pharmacist
, pp. 25-30
-
-
Khar, R.K.1
Pandita, D.2
-
15
-
-
77957577340
-
Dissolution testing for immediate release solid oral dosage forms
-
Guidance for industry, August
-
Guidance for industry, "Dissolution testing for immediate release solid oral dosage forms," FDA, August 1997.
-
(1997)
FDA
-
-
-
16
-
-
33845875000
-
Dissolution: A promising tool in drug delivery
-
Nov-Dec
-
Ahuja A, Baboota S, Ali J, "Dissolution: a promising tool in drug delivery," Indian J. Pharm. Sci., Nov- Dec 2005, 650-660.
-
(2005)
Indian J. Pharm. Sci.
, pp. 650-660
-
-
Ahuja, A.1
Baboota, S.2
Ali, J.3
-
17
-
-
0031750861
-
Evaluation of various dissolution media predicting in vivo performance of class I and Class II drugs
-
Galia E, nicolaides E, Lobenberg RD, Dressman JB, "Evaluation of various dissolution media predicting in vivo performance of class I and Class II drugs," Pharm Res. 1998,15, 698-705.
-
(1998)
Pharm Res.
, vol.15
, pp. 698-705
-
-
Galia, E.1
Nicolaides, E.2
Lobenberg, R.D.3
Dressman, J.B.4
-
18
-
-
77957577628
-
-
USP-27th edition, NF-22nd edition, Inc., Rockville, M.D
-
USP-27th edition, NF-22nd edition, United state pharmacoepial convention, Inc., Rockville, M.D., 2004, Page No 2313-2314
-
(2004)
United state pharmacoepial convention
, pp. 2313-2314
-
-
-
20
-
-
0023097483
-
Dissolution for controlled release theophylline formulations in Milk
-
Macheras P, koupparis M, Apostelelli E, "Dissolution for controlled release theophylline formulations in Milk," Int. J. Pharm. 2007, 36, 73-79.
-
(2007)
Int. J. Pharm.
, vol.36
, pp. 73-79
-
-
Macheras, P.1
Koupparis, M.2
Apostelelli, E.3
-
21
-
-
0024535990
-
In-vitro dissolution testing of oral controlled release preparation in the presence of artificial food stuff
-
Ashby LJ, Beezer AE, Buckton G, "In-vitro dissolution testing of oral controlled release preparation in the presence of artificial food stuff," Int. J. Pharm., 1989,51, 245-251
-
(1989)
Int. J. Pharm.
, vol.51
, pp. 245-251
-
-
Ashby, L.J.1
Beezer, A.E.2
Buckton, G.3
-
23
-
-
0003400770
-
-
Doctoral dissertation, the university of Michign, Ann Arbor, MI
-
Greenwood DE, "Small intestinal pH and buffer capacity: implications for dissolution of ionizable compounds," Doctoral dissertation, the university of Michign, Ann Arbor, MI, 1994.
-
(1994)
Small intestinal pH and buffer capacity: Implications for dissolution of ionizable compounds
-
-
Greenwood, D.E.1
-
24
-
-
77957558877
-
-
USP-27th edition, NF-22nd edition, Inc., Rockville, M.D
-
USP-27th edition, NF-22nd edition, United state pharmacoepial convention, Inc., Rockville, M.D., 2004, Page No 2303-2312.
-
(2004)
United state pharmacoepial convention
, pp. 2303-2312
-
-
-
26
-
-
0030867432
-
-
FIP guidelines for dissolution testing of solid oral products, 760-760
-
FIP guidelines for dissolution testing of solid oral products, Pharm Ind., 1997, 59, 760-760.
-
(1997)
Pharm Ind.
, vol.59
-
-
-
27
-
-
0004037003
-
-
3rd edition, Appleton and Lange, Stamford, Connecticut
-
L Shargel, ABC Yu, "Applied biopharmaceutics and pharmacokinetics," 3rd edition, Appleton and Lange, Stamford, Connecticut, 1999. page no 365-376
-
(1999)
Applied biopharmaceutics and pharmacokinetics
, pp. 365-376
-
-
Shargel, L.1
Yu, A.B.C.2
-
28
-
-
14744272833
-
The use of biopharmaceutics classification of drugs in drug discovery and development: Current status and future extensions
-
Lennernäs H and Abrahamsson B, "The use of biopharmaceutics classification of drugs in drug discovery and development: current status and future extensions," J. Pharm. Pharmacol. 2005, 57, 273-285.
-
(2005)
J. Pharm. Pharmacol.
, vol.57
, pp. 273-285
-
-
Lennernäs, H.1
Abrahamsson, B.2
-
29
-
-
0033816196
-
Intestinal permeation enhancers
-
Aungst BJ, Intestinal permeation enhancers. J. Pharm. Sci. 2000, 89(4): 429-442.
-
(2000)
J. Pharm. Sci.
, vol.89
, Issue.4
, pp. 429-442
-
-
Aungst, B.J.1
-
30
-
-
0347359134
-
Intestinal solute carriers: An overview of trends and strategies for improving oral drug absorption
-
Steffansen B, Nielsen CU, Brodin B, Eriksson AH, Andersen R and Frokjaer S, "Intestinal solute carriers: an overview of trends and strategies for improving oral drug absorption," Eur. J. Pharm. Sci. 2004, 21, 3-16.
-
(2004)
Eur. J. Pharm. Sci.
, vol.21
, pp. 3-16
-
-
Steffansen, B.1
Nielsen, C.U.2
Brodin, B.3
Eriksson, A.H.4
Andersen, R.5
Frokjaer, S.6
-
31
-
-
0022645133
-
Enalapril a review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in hypertension and congestive heart failure
-
Todd PA and Heel RC, "Enalapril a review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in hypertension and congestive heart failure. Drugs, 1986, 31(3): 198-248.
-
(1986)
Drugs
, vol.31
, Issue.3
, pp. 198-248
-
-
Todd, P.A.1
Heel, R.C.2
-
32
-
-
0346958512
-
Design of ester prodrugs to enhance oral absorption of poorly permeable compounds: Challenges to the discovery scientist
-
Beaumont K, Webster R, Gardner I and Dack K, "Design of ester prodrugs to enhance oral absorption of poorly permeable compounds: Challenges to the discovery scientist. Curr. Drug Metab. 2003, 4, 461-485.
-
(2003)
Curr. Drug Metab.
, vol.4
, pp. 461-485
-
-
Beaumont, K.1
Webster, R.2
Gardner, I.3
Dack, K.4
-
33
-
-
0019423872
-
Pharmacokinetics and bioavailability of ranitidine in humans
-
Bogues K, Dixon GT, Fowler P, Jenner WN, Maconochie JG, Martin LE and Willoughby BA, "Pharmacokinetics and bioavailability of ranitidine in humans," Br. J. Clin. Pharmacol. 1980, 73, 275-276.
-
(1980)
Br. J. Clin. Pharmacol.
, vol.73
, pp. 275-276
-
-
Bogues, K.1
Dixon, G.T.2
Fowler, P.3
Jenner, W.N.4
Maconochie, J.G.5
Martin, L.E.6
Willoughby, B.A.7
-
34
-
-
0019523595
-
Pharmacokinetics of ranitidine, a new histamine H2-receptor blocker
-
Garg DC, Weidler DJ, Baltodano N, Eshelman FN, "Pharmacokinetics of ranitidine, a new histamine H2-receptor blocker," Br. J. Clin. Pharmacol.1981, 29(2): 247-248.
-
(1981)
Br. J. Clin. Pharmacol.
, vol.29
, Issue.2
, pp. 247-248
-
-
Garg, D.C.1
Weidler, D.J.2
Baltodano, N.3
Eshelman, F.N.4
-
35
-
-
33645503065
-
Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products cimetidine
-
Jantratid E., Prakongpan S., Amidon G.L. and Dressman J.B., Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products cimetidine. Clin. Pharmacokinetic., 2006, 45(4): 385-399.
-
(2006)
Clin. Pharmacokinetic.
, vol.45
, Issue.4
, pp. 385-399
-
-
Jantratid, E.1
Prakongpan, S.2
Amidon, G.L.3
Dressman, J.B.4
-
36
-
-
84857635078
-
Immediate-release solid oral dosage forms, scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalency documentation
-
Guidance for industry, August
-
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 bioequivalency documentation. CDER/FDA, August 1995
-
(1995)
CDER/FDA
-
-
-
38
-
-
2642530433
-
Summary workshop report: Biopharmaceutics classification system- implementation challenges and extension opportunities
-
Polli JE, Yu LX, Cook JA, Amidon LA, Borchardt RT, Burnside BA, Burton PS, Chen M-L, Conner DP, Faustino PJ, Hawi AA, Hussain AS, Joshi HN, Kwei G, Lee VHL, Lesko LJ, Lipper RA, Loper AE, Nerurkar SG, Polli JW, Sanvordeker DR, Taneja R, Uppoor RS, Vattikonda CS, Wilding I and Zhang G, Summary workshop report: Biopharmaceutics classification system- implementation challenges and extension opportunities. J. Pharm. Sci.2005, 93(6): 1375-1381
-
(2005)
J. Pharm. Sci.
, vol.93
, Issue.6
, pp. 1375-1381
-
-
Polli, J.E.1
Yu, L.X.2
Cook, J.A.3
Amidon, L.A.4
Borchardt, R.T.5
Burnside, B.A.6
Burton, P.S.7
Chen, M-L.8
Conner, D.P.9
Faustino, P.J.10
Hawi, A.A.11
Hussain, A.S.12
Joshi, H.N.13
Kwei, G.14
Lee, V.H.L.15
Lesko, L.J.16
Lipper, R.A.17
Loper, A.E.18
Nerurkar, S.G.19
Polli, J.W.20
Sanvordeker, D.R.21
Taneja, R.22
Uppoor, R.S.23
Vattikonda, C.S.24
Wilding, I.25
Zhang, G.26
more..
-
39
-
-
33750161035
-
Review of global regulations concerning biowaivers for immediate release solid oral dosage forms
-
Gupta E., Barends DM, Yamashita E, Lentz KA, Harmsze AM, Shah VP, Dressman JB and Lipper RA,. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. Eur. J. Pharm. Sci. 2006, 26, 315-324.
-
(2006)
Eur. J. Pharm. Sci.
, vol.26
, pp. 315-324
-
-
Gupta, E.1
Barends, D.M.2
Yamashita, E.3
Lentz, K.A.4
Harmsze, A.M.5
Shah, V.P.6
Dressman, J.B.7
Lipper, R.A.8
-
40
-
-
77957604565
-
Concept paper on BCS based biowaiver
-
The European Agency for the Evaluation of Medicinal Products (EMEA)
-
The European Agency for the Evaluation of Medicinal Products (EMEA), Concept paper on BCS based biowaiver. Committee for Medicinal Products for Human Use, 2007
-
(2007)
Committee for Medicinal Products for Human Use
-
-
-
41
-
-
34447336490
-
Application and experience in the EU of BCS in the review of new generics
-
Barends DM, Application and experience in the EU of BCS in the review of new generics, J. Pharm.Pharmacol, 2005, 57(11): 117
-
(2005)
J. Pharm.Pharmacol
, vol.57
, Issue.11
, pp. 117
-
-
Barends, D.M.1
-
42
-
-
0035997323
-
Biopharmaceutics classification system: The scientific basis for biowaiver extensions
-
Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, Shah VP, Lesko LJ, Chen ML, Lee VHL and Hussain AS Biopharmaceutics classification system: the scientific basis for biowaiver extensions, Pharm. Res 2002,19 (7): 921-925.
-
(2002)
Pharm. Res
, vol.19
, Issue.7
, pp. 921-925
-
-
Yu, L.X.1
Amidon, G.L.2
Polli, J.E.3
Zhao, H.4
Mehta, M.U.5
Conner, D.P.6
Shah, V.P.7
Lesko, L.J.8
Chen, M.L.9
Lee, V.H.L.10
Hussain, A.S.11
-
43
-
-
1242337282
-
The "high solubility" definition of the current FDA guidance on biopharmaceutical classification system may be too strict for acidic drugs
-
Yazdanian M, Briggs K, Jankovsky C and Hawi A, The "high solubility" definition of the current FDA guidance on biopharmaceutical classification system may be too strict for acidic drugs, Pharm. Res. 2004, 21(2): 293-299.
-
(2004)
Pharm. Res.
, vol.21
, Issue.2
, pp. 293-299
-
-
Yazdanian, M.1
Briggs, K.2
Jankovsky, C.3
Hawi, A.4
-
44
-
-
15244341878
-
Identification of biowaivers among class II drugs: Theoretical justification and practical examples
-
Rinaki E, Dokoumetzidis A, Valsami G and Macheras P,. Identification of biowaivers among class II drugs: theoretical justification and practical examples. Pharm. Res. 2004,21(9): 1567-1572.
-
(2004)
Pharm. Res.
, vol.21
, Issue.9
, pp. 1567-1572
-
-
Rinaki, E.1
Dokoumetzidis, A.2
Valsami, G.3
Macheras, P.4
-
45
-
-
0011280557
-
The effect of in vivo dissolution, gastric emptying rate, and intestinal transit time on the peak concentration and area-under-the-curve of drugs with different gastrointestinal permeabilities
-
Kaus LC, Gillespie WR, Hussain AS and Amidon GL, The effect of in vivo dissolution, gastric emptying rate, and intestinal transit time on the peak concentration and area-under-the-curve of drugs with different gastrointestinal permeabilities. Pharm. Res. 1999, 16(2): 272-280.
-
(1999)
Pharm. Res.
, vol.16
, Issue.2
, pp. 272-280
-
-
Kaus, L.C.1
Gillespie, W.R.2
Hussain, A.S.3
Amidon, G.L.4
-
46
-
-
0000424681
-
The stomach: Its role in oral drug delivery
-
Edited rubinstein MH, Chichester, UK, Ellis horwood
-
Wilson CG and Washington N, The stomach: its role in oral drug delivery. In physiological pharmaceutical: Biological barriers to drug absorption, Edited rubinstein MH, Chichester, UK, Ellis horwood: 1989, 47-70.
-
(1989)
In physiological pharmaceutical: Biological barriers to drug absorption
, pp. 47-70
-
-
Wilson, C.G.1
Washington, N.2
-
47
-
-
40549099693
-
Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability
-
WHO
-
WHO, Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, Annex 7, WHO technical report series no. 937, 2006.
-
(2006)
Annex 7, WHO technical report series no. 937
-
-
-
48
-
-
3843072170
-
Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system literature data: Verapamil hydrochloride, Propranolol hydrochloride, and Atenolol
-
Vogelpoel H, Welink J, Amidon GL, Junginger HE, Midha KK, Möller H., Olling M., Shah VP and Barends DM, Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system literature data: Verapamil hydrochloride, Propranolol hydrochloride, and Atenolol. J. Pharm. Sci. 2004, 93(8): 1945-1956.
-
(2004)
J. Pharm. Sci.
, vol.93
, Issue.8
, pp. 1945-1956
-
-
Vogelpoel, H.1
Welink, J.2
Amidon, G.L.3
Junginger, H.E.4
Midha, K.K.5
Möller, H.6
Olling, M.7
Shah, V.P.8
Barends, D.M.9
-
49
-
-
2942529161
-
Biowaiver extension potential to BCS class III high solubility-low permeability drugs: Bridging evidence for metformin immediate-release tablets
-
Cheng CL., Yu LX, Lee HL., Yang CY, Lue CS and Chou CH, "Biowaiver extension potential to BCS class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablets", Eur. J Pharm. Sci. 2004,22: 297-304.
-
(2004)
Eur. J Pharm. Sci.
, vol.22
, pp. 297-304
-
-
Cheng, C.L.1
Yu, L.X.2
Lee, H.L.3
Yang, C.Y.4
Lue, C.S.5
Chou, C.H.6
-
50
-
-
0033407634
-
The biopharmaceutics classification system (BCS): Class III drugs better candidates for BA/BE waiver?
-
Blume HH and Schug BS, "The biopharmaceutics classification system (BCS): Class III drugs better candidates for BA/BE waiver"? Eur. J. Pharm. Sci, 1999, 9: 117-121
-
(1999)
Eur. J. Pharm. Sci
, vol.9
, pp. 117-121
-
-
Blume, H.H.1
Schug, B.S.2
|