-
1
-
-
77649230445
-
Evolution of the principal US food & drug laws
-
Sharma KN, Sharma KK, Sen P, editors New Delhi, University College of Medical Sciences, 1990. Ring Road, New Delhi 110-029: University College of Medical Sciences
-
Seife, M. Evolution of the principal US food & drug laws. In: Sharma KN, Sharma KK, Sen P, editors. Generic drugs, bioequivalence and pharmacokinetics: Proceedings of the Indo-US Symposium, New Delhi, University College of Medical Sciences, 1990. Ring Road, New Delhi 110-029: University College of Medical Sciences; 1990. p. 7-14.
-
(1990)
Generic Drugs, Bioequivalence and Pharmacokinetics: Proceedings of the Indo-US Symposium
, pp. 7-14
-
-
Seife, M.1
-
2
-
-
77649227511
-
-
U.S. Department of Health and Human Services. A brief history of the center for drug evaluation and research
-
U.S. Department of Health and Human Services. A brief history of the center for drug evaluation and research. 2009. http://www.fda.gov/cder/about/ history/Histext.htm. Accessed March 2009.
-
(2009)
-
-
-
3
-
-
77649197424
-
-
U.S. Department of Health and Human Services. A brief history of the center for drug evaluation and research
-
U.S. Department of Health and Human Services. A brief history of the center for drug evaluation and research. 2009. http://www.fda.gov/aboutFDA/ whatwedo/history/thisweek/ucm117833.htm.
-
(2009)
-
-
-
4
-
-
77649210454
-
Bioavailability policies and guidelines; In industrial bioavailability and pharmacokinetics-guidelines and controls
-
A. Martin J.T. Doluisio (eds). University of Texas Austin
-
Skelly JP. Bioavailability policies and guidelines; in industrial bioavailability and pharmacokinetics-guidelines and controls. In: Martin A, Doluisio JT, editors. College of pharmacy, drug dynamics institute. Austin: University of Texas; 1977. p. 2-41.
-
(1977)
College of Pharmacy, Drug Dynamics Institute
, pp. 2-41
-
-
Skelly, J.P.1
-
6
-
-
77649225892
-
-
United States of America versus Premo laboratories, Inc. and Seymour Blackman; United States District Court, District of New Jersey
-
United States of America versus Premo laboratories, Inc. and Seymour Blackman; United States District Court, District of New Jersey. 1980.
-
(1980)
-
-
-
10
-
-
77649229439
-
An industrial view of the official compendia
-
A. Martin J.T. Doluisio (eds). College of pharmacy, Drug Dynamics Institute Austin
-
Marcus A. An industrial view of the official compendia. In: Martin A, Doluisio JT, editors. Industrial bioavailability and pharmacokinetics- guidelines, regulations and controls. Austin: College of pharmacy, Drug Dynamics Institute; 1977. p. 223-32.
-
(1977)
Industrial Bioavailability and Pharmacokinetics-guidelines, Regulations and Controls
, pp. 223-32
-
-
Marcus, A.1
-
11
-
-
0015229770
-
Bioavailability of Digoxin
-
Editorial
-
Vitti TG, Banes D, Byers TE. Bioavailability of Digoxin, Editorial, NEJM Nov. 1971;(25):1433-44.
-
(1971)
NEJM Nov.
, Issue.25
, pp. 1433-1444
-
-
Vitti, T.G.1
Banes, D.2
Byers, T.E.3
-
13
-
-
0015918335
-
Equivalence lack in digoxin plasma levels
-
10.1001/jama.224.2.199 1:CAS:528:DyaE3sXkt1Oms7g%3D 4739492
-
JG Wagner M Christensen E Sakmar D Blair JD Yates PW Willis AJ Sedman RG Stoll 1973 Equivalence lack in digoxin plasma levels JAMA 224 199 204 10.1001/jama.224.2.199 1:CAS:528:DyaE3sXkt1Oms7g%3D 4739492
-
(1973)
JAMA
, vol.224
, pp. 199-204
-
-
Wagner, J.G.1
Christensen, M.2
Sakmar, E.3
Blair, D.4
Yates, J.D.5
Willis, P.W.6
Sedman, A.J.7
Stoll, R.G.8
-
14
-
-
0015257283
-
Assessment of the biological availability of tetracycline products in man
-
1:CAS:528:DyaE38XhtlGqtb4%3D
-
WH Barr LM Gerbracht K Letcher M Plaut N Strahl 1972 Assessment of the biological availability of tetracycline products in man Clin Pharm Ther 13 97 1:CAS:528:DyaE38XhtlGqtb4%3D
-
(1972)
Clin Pharm Ther
, vol.13
, pp. 97
-
-
Barr, W.H.1
Gerbracht, L.M.2
Letcher, K.3
Plaut, M.4
Strahl, N.5
-
15
-
-
0014309824
-
An evaluation of absorption of chloramphenicol preparations in normal human subjects
-
1:CAS:528:DyaF1cXksFSqsb8%3D
-
AJ Glazko AW Kinkel WC Alegnani EL Holmes 1968 An evaluation of absorption of chloramphenicol preparations in normal human subjects Clin Pharm Ther 9 472 1:CAS:528:DyaF1cXksFSqsb8%3D
-
(1968)
Clin Pharm Ther
, vol.9
, pp. 472
-
-
Glazko, A.J.1
Kinkel, A.W.2
Alegnani, W.C.3
Holmes, E.L.4
-
18
-
-
77649210652
-
Topical corticosteroid induced skin blanching-eye or instrument
-
JP Skelly VP Shah C Peck 1065 Topical corticosteroid induced skin blanching-eye or instrument Arch Dermatol 1991 127
-
(1065)
Arch Dermatol
, vol.1991
, pp. 127
-
-
Skelly, J.P.1
Shah, V.P.2
Peck, C.3
-
19
-
-
0024438244
-
'Vasoconstriction' - Skin blanching - Assay for glucocorticoids - A critique
-
DOI 10.1001/archderm.125.11.1558
-
VP Shah C Peck JP Skelly 1989 Vasoconstriction-skin blanching; assay for glucocorticoids: a critique Arch Dermatol 125 1558 61 10.1001/archderm.125.11. 1558 1:STN:280:DyaK3c%2FlsFansw%3D%3D 2817920 (Pubitemid 19280893)
-
(1989)
Archives of Dermatology
, vol.125
, Issue.11
, pp. 1558-1561
-
-
Shah, V.P.1
Peck, C.C.2
Skelly, J.P.3
-
20
-
-
0023200675
-
Are generic formulations equivalent to trade name topical glucocorticoids
-
10.1001/archderm.123.10.1312
-
RB Stoughton 1087 Are generic formulations equivalent to trade name topical glucocorticoids Arch Dermatol 123 1312 4 10.1001/archderm.123.10.1312
-
(1087)
Arch Dermatol
, vol.123
, pp. 1312-4
-
-
Stoughton, R.B.1
-
21
-
-
84941818257
-
Method for comparing percutaneous absorption of steroids
-
AW McKenzie RB Stoughton 1962 Method for comparing percutaneous absorption of steroids Arch Dermatol. 86 741 6
-
(1962)
Arch Dermatol.
, vol.86
, pp. 741-6
-
-
McKenzie, A.W.1
Stoughton, R.B.2
-
22
-
-
0344586290
-
-
B.B. Brodie W.M. Heller S. Bazel (eds). Karger Basel
-
Brodie BB, Heller WM, Bazel S, editors. Bioavailability of drugs. Basel: Karger; 1972.
-
(1972)
Bioavailability of Drugs
-
-
-
23
-
-
84986665692
-
FDA 75/75 rule: A response
-
10.1002/jps.2600720128
-
JD Haynes 1983 FDA 75/75 rule: a response J Pharm Sci 72 99 100 10.1002/jps.2600720128
-
(1983)
J Pharm Sci
, vol.72
, pp. 99-100
-
-
Haynes, J.D.1
-
24
-
-
0000117116
-
Aon hypothesis testing to determine if the mean of a normal distribution is contained in a known interval
-
DL Schuirmann 1981 Aon hypothesis testing to determine if the mean of a normal distribution is contained in a known interval (Abstract) Biometrics 37 617
-
(1981)
(Abstract) Biometrics
, vol.37
, pp. 617
-
-
Schuirmann, D.L.1
-
25
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
-
10.1007/BF01068419 1:STN:280:DyaL1c3jtVajtQ%3D%3D 3450848
-
DJ Schuirmann 1987 A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability J Pharmacokinet Biopharm 15 657 80 10.1007/BF01068419 1:STN:280: DyaL1c3jtVajtQ%3D%3D 3450848
-
(1987)
J Pharmacokinet Biopharm
, vol.15
, pp. 657-80
-
-
Schuirmann, D.J.1
-
26
-
-
0024988106
-
Consideration of individual bioequivalence
-
10.1007/BF01062202 1:STN:280:DyaK3czjvFekuw%3D%3D 2380920
-
S Anderson WW Hauck 1990 Consideration of individual bioequivalence J Pharmacokinet Biopharm 18 259 73 10.1007/BF01062202 1:STN:280: DyaK3czjvFekuw%3D%3D 2380920
-
(1990)
J Pharmacokinet Biopharm
, vol.18
, pp. 259-73
-
-
Anderson, S.1
Hauck, W.W.2
-
29
-
-
77649198797
-
-
Federal Register January 22
-
Federal Register January 22, 1974.
-
(1974)
-
-
-
30
-
-
77649229646
-
-
Federal Register February 1
-
Federal Register February 1, 1974.
-
(1974)
-
-
-
31
-
-
77649225248
-
FDA update: Dissolution testing: Simple tool-important contribution
-
Skelly JP, Gonzalez MA. FDA update: dissolution testing: simple tool-important contribution. Eur J Biopharm. 1993;39(5):222-3.
-
(1993)
Eur J Biopharm.
, vol.39
, Issue.5
, pp. 222-233
-
-
Skelly, J.P.1
Gonzalez, M.A.2
-
33
-
-
77649203260
-
Dissolution testing: Need for standardization
-
JP Skelly 1977 Dissolution testing: need for standardization Pharm Tech 1 5 12
-
(1977)
Pharm Tech
, vol.1
, Issue.5
, pp. 12
-
-
Skelly, J.P.1
-
34
-
-
0017889885
-
Tetracycline: Another example of generic bioinequivalence
-
Wood J, Flora KP, Duma RJ. Tetracycline: another example of generic bioinequivalence. JAMA. 1978;239(18):1874-76.
-
(1978)
JAMA.
, vol.239
, Issue.18
, pp. 1874-1876
-
-
Wood, J.1
Flora, K.P.2
Duma, R.J.3
-
35
-
-
0021821619
-
Food induced 'dose dumping' from a once-a-day theophylline product as a cause of theophylline toxicity
-
Hendeles L, Weinberger G, Milavetz G, Hill M, Vaughn L. Food induced 'dose dumping' from a once-a-day theophylline product as a cause of theophylline toxicity. Chest. 1985;87:758-65.
-
(1985)
Chest
, vol.87
, pp. 758-765
-
-
Hendeles, L.1
Weinberger, G.2
Milavetz, G.3
Hill, M.4
Vaughn, L.5
-
36
-
-
0023090959
-
Report of the workshop on controlled-release dosage forms: Issues and controversies
-
DOI 10.1023/A:1016494314263
-
JP Skelly WH Barr LZ Benet JT Doluisio G Goldberg DT Lowenthal JR Robinson VP Shah RJ Temple A Yacobi 1987 Report of the workshop on controlled release dosage forms: issues and controversies Pharm Res 4 1 75 7 10.1023/A:1016494314263 (Pubitemid 17050749)
-
(1987)
Pharmaceutical Research
, vol.4
, Issue.1
, pp. 75-77
-
-
Skelly, J.P.1
Barr, W.H.2
Benet, L.Z.3
-
37
-
-
0025147050
-
In vitro and in vivo testing and correlations for oral controlled/modified-release dosage forms
-
10.1023/A:1015970512368
-
JP Skelly GL Amidon WH Barr LZ Benet JE Carter JR Robinson VP Shah A Yacobi 1990 In vitro and in vivo testing and correlations for oral controlled/modified-release dosage forms Pharm Res 7 9 975 82 10.1023/A:1015970512368
-
(1990)
Pharm Res
, vol.7
, Issue.9
, pp. 975-82
-
-
Skelly, J.P.1
Amidon, G.L.2
Barr, W.H.3
Benet, L.Z.4
Carter, J.E.5
Robinson, J.R.6
Shah, V.P.7
Yacobi, A.8
-
38
-
-
0023184892
-
FDA & AAPS report of the workshop on principles and practices of in vitro percutaneous and penetration studies: Relevance to bioavailability and bioequivalence
-
10.1023/A:1016428716506
-
JP Skelly VP Shah HI Maibach RH Guy RC Wester G Flynn A Yacobi 1987 FDA & AAPS report of the workshop on principles and practices of in vitro percutaneous and penetration studies: relevance to bioavailability and bioequivalence Pharm Res 4 3 265 7 10.1023/A:1016428716506
-
(1987)
Pharm Res
, vol.4
, Issue.3
, pp. 265-7
-
-
Skelly, J.P.1
Shah, V.P.2
Maibach, H.I.3
Guy, R.H.4
Wester, R.C.5
Flynn, G.6
Yacobi, A.7
-
39
-
-
0025874404
-
In vivo percutaneous penetration/absorption
-
10.1023/A:1015829729439 1:STN:280:DyaK38%2FitVKmtA%3D%3D 1924164
-
VP Shah GL Flynn RH Guy HI Maibach H Schaefer JP Skelly RC Wester A Yacobi 1991 In vivo percutaneous penetration/absorption Pharm Res 8 8 1071 5 10.1023/A:1015829729439 1:STN:280:DyaK38%2FitVKmtA%3D%3D 1924164
-
(1991)
Pharm Res
, vol.8
, Issue.8
, pp. 1071-5
-
-
Shah, V.P.1
Flynn, G.L.2
Guy, R.H.3
Maibach, H.I.4
Schaefer, H.5
Skelly, J.P.6
Wester, R.C.7
Yacobi, A.8
-
40
-
-
0026606194
-
Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
-
10.1023/A:1015829422034
-
VP Shah KK Midha S Dighe I McGilveray JP Skelly A Yacobi T Layloff CT Viswanathan, et al. 1992 Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies Pharm Res 9 4 588 92 10.1023/A:1015829422034
-
(1992)
Pharm Res
, vol.9
, Issue.4
, pp. 588-92
-
-
Shah, V.P.1
Midha, K.K.2
Dighe, S.3
McGilveray, I.4
Skelly, J.P.5
Yacobi, A.6
Layloff, T.7
Viswanathan, C.T.8
-
41
-
-
0027473743
-
Scaleup of immediate release oral solid dosage forms
-
DOI 10.1023/A:1018915700942
-
JP Skelly JP Van Buskirk, et al. 1993 Workshop report: scale-up of immediate release oral solid dosage forms Pharm Res 10 313 6 10.1023/A:1018915700942 1:STN:280:DyaK3s3gsFKmtA%3D%3D 8456084 (Pubitemid 23041751)
-
(1993)
Pharmaceutical Research
, vol.10
, Issue.2
, pp. 313-316
-
-
Skelly, J.P.1
Van Burskirk, G.A.2
Savello, D.R.3
Amidon, G.L.4
Arbit, H.M.5
Dighe, S.6
Fawzi, M.B.7
Gonzalez, M.A.8
Malick, A.W.9
Malinowski, H.10
Nedich, R.11
Peck, G.E.12
Pearce, D.M.13
Shah, V.14
Shangraw, R.F.15
Schwartz, J.B.16
Truelove, J.17
-
42
-
-
0027144435
-
Scaleup of oral extended-release dosage forms
-
DOI 10.1023/A:1018946819849
-
JP Skelly JP Van Buskirk, et al. 1993 Scale-up of oral extended release dosage forms Pharm Res 10 1800 5 10.1023/A:1018946819849 1:STN:280: DyaK2c7jsVKhsw%3D%3D 8302770 (Pubitemid 24000370)
-
(1993)
Pharmaceutical Research
, vol.10
, Issue.12
, pp. 1800-1805
-
-
Skelly, J.P.1
Van Buskirk, G.A.2
Arbit, H.M.3
Amidon, G.L.4
Augsburger, L.5
Barr, W.H.6
Berge, S.7
Clevenger, J.8
Dighe, S.9
Fawzi, M.10
Fox, D.11
Gonzalez, M.A.12
Gray, V.A.13
Hoiberg, C.14
Leeson, L.J.15
Lesko, L.16
Malinowski, H.17
Nixon, P.R.18
Pearce, D.M.19
-
43
-
-
0028088319
-
Workshop III report: Scaleup of liquid and semisolid disperse systems
-
DOI 10.1023/A:1018913605176
-
JP Van Buskirk, et al. 1994 Scale-up of liquid and semisolid disperse systems Pharm Res 11 1216 20 10.1023/A:1018913605176 (Pubitemid 24259867)
-
(1994)
Pharmaceutical Research
, vol.11
, Issue.8
, pp. 1216-1220
-
-
Van Buskirk, G.A.1
Shah, V.P.2
Adair, D.3
Arbit, H.M.4
Dighe, S.V.5
Fawzi, M.6
Feldman, T.7
Flynn, G.L.8
Gonzalez, M.A.9
Gray, V.A.10
Guy, R.H.11
Herd, A.K.12
Hem, S.L.13
Hoiberg, C.14
Jerussi, R.15
Kaplan, A.S.16
Lesko, L.J.17
Malinowski, H.J.18
Meltzer, N.M.19
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