-
1
-
-
84871520930
-
A review of convulsion and seizure incidence: Small versus large molecule experience
-
(in preparation)
-
Amouzadeh H, Vargas HM (2012) A review of convulsion and seizure incidence: small versus large molecule experience. J Pharmacol Toxicol Methods (in preparation).
-
(2012)
J Pharmacol Toxicol Methods
-
-
Amouzadeh, H.1
Vargas, H.M.2
-
2
-
-
68849119066
-
Alternative strategies for toxicity testing of species-specific biopharmaceuticals
-
Bussiere JL, Martin P, Horner M, Couch J, Flaherty M, Andrews L, Beyer J, Horvath C (2009) Alternative strategies for toxicity testing of species-specific biopharmaceuticals. Int J Toxicol 28:230-253
-
(2009)
Int J Toxicol
, vol.28
, pp. 230-253
-
-
Bussiere, J.L.1
Martin, P.2
Horner, M.3
Couch, J.4
Flaherty, M.5
Rews, L.6
Beyer, J.7
Horvath, C.8
-
3
-
-
33947587491
-
Preclinical safety testing of biological: The significance of species relevance
-
Chapman K, Pullen N, Graham M, Ragan I (2007) Preclinical safety testing of biological: the significance of species relevance. Nature Drug Discovery 6:120-126
-
(2007)
Nature Drug Discovery
, vol.6
, pp. 120-126
-
-
Chapman, K.1
Pullen, N.2
Graham, M.3
Ragan, I.4
-
4
-
-
68549134977
-
Assessment of two external telemetry systems (Physiojacket™ and jettm) in beagle dogs with telemetry implants
-
Chui RW, Fosdick A, Conner R, Jiang J, Bruenner BA, Vargas HM (2009) Assessment of two external telemetry systems (PhysioJacket™ and JETtm) in beagle dogs with telemetry implants. J Pharmacol Toxicol Methods 60:58-68
-
(2009)
J Pharmacol Toxicol Methods
, vol.60
, pp. 58-68
-
-
Chui, R.W.1
Fosdick, A.2
Conner, R.3
Jiang, J.4
Bruenner, B.A.5
Vargas, H.M.6
-
5
-
-
84871477604
-
Long-term assessment of non-human primate ecg using jacketed external telemetry (Jet): Evaluation of heart rate and qtc interval variation over 6 months of observation
-
Chui RW, Derakhchan K, Vargas HM (2011) Long-term assessment of non-human primate ECG using jacketed external telemetry (JET): evaluation of heart rate and QTc interval variation over 6 months of observation. J Pharmacol Toxicol Methods 64:e45
-
(2011)
J Pharmacol Toxicol Methods
, vol.64
-
-
Chui, R.W.1
Derakhchan, K.2
Vargas, H.M.3
-
6
-
-
0141922918
-
Shifting paradigms: Biopharmaceuticals versus low molecular weight drugs
-
Crommelin DJA, Storm G, Verrijk R, de Leede L, Jiskoot W, Hennick WE (2003) Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharmaceutics 266:3-16
-
(2003)
Int J Pharmaceutics
, vol.266
, pp. 3-16
-
-
Crommelin, D.1
Storm, G.2
Verrijk, R.3
De Leede, L.4
Jiskoot, W.5
Hennick, W.E.6
-
7
-
-
84934988760
-
Evaluation of cardiac conduction disturbances using jacketed external telemetry (Jet) in conscious non-human primates
-
Derakhchan K, Chui RW, Vargas HM (2011) Evaluation of cardiac conduction disturbances using jacketed external telemetry (JET) in conscious non-human primates. J Pharmacol Toxicol Methods 64:e46
-
(2011)
J Pharmacol Toxicol Methods
, pp. 64
-
-
Derakhchan, K.1
Chui, R.W.2
Vargas, H.M.3
-
8
-
-
54149095750
-
Whole-body plethysmography in african green monkeys (Chlorocebus aethiops) with and without jackets
-
Foster CD, Hunter TC, Gibbs PH, Leffel EK (2008) Whole-body plethysmography in African green monkeys (Chlorocebus aethiops) with and without jackets. J Am Assoc Lab Anim Sci 47:52-55
-
(2008)
J am Assoc Lab Anim Sci
, vol.47
, pp. 52-55
-
-
Foster, C.D.1
Hunter, T.C.2
Gibbs, P.H.3
Leffel, E.K.4
-
9
-
-
0032600640
-
A knowledge-based approach in designing combinatorial or medicinal chemistry libraries for drug discovery. 1. A qualitative and quantitative characterization of known drug databases
-
Ghose AK, Viswanadhan VN, Wendoloski JJ (1999) A knowledge-based approach in designing combinatorial or medicinal chemistry libraries for drug discovery. 1. A qualitative and quantitative characterization of known drug databases. J Comb Chem 1:55-68
-
(1999)
J Comb Chem
, vol.1
, pp. 55-68
-
-
Ghose, A.K.1
Viswanadhan, V.N.2
Wendoloski, J.J.3
-
10
-
-
54349091558
-
Safety-related regulatory actions for biologicals approved in the united states and the european union
-
Giezen TJ, Mantel-Teeuwisse AK, Straus SJJM, Schellekens H, Leufkens HGM, Egherts ACG (2008) Safety-related regulatory actions for biologicals approved in the United States and the European Union. J Am Med Assoc 300:1887-1896
-
(2008)
J am Med Assoc
, vol.300
, pp. 1887-1896
-
-
Giezen, T.J.1
Mantel-Teeuwisse, A.K.2
Straus, S.3
Schellekens, H.4
Leufkens, H.5
Egherts, A.6
-
11
-
-
0030458024
-
Recombinant protein and therapeutic monoclonal antibody drug development in the united states from 1980-1994
-
Gosse ME, DiMasi JA, Nelson TF (1996) Recombinant protein and therapeutic monoclonal antibody drug development in the United States from 1980-1994. Clin Pharmacol Ther 60:608-618
-
(1996)
Clin Pharmacol Ther
, vol.60
, pp. 608-618
-
-
Gosse, M.E.1
Di Masi, J.A.2
Nelson, T.F.3
-
12
-
-
0030793458
-
Problems associated with the absence of activity in standard models of safety pharmacology used to assess biologic products
-
Green MD (1997) Problems associated with the absence of activity in standard models of safety pharmacology used to assess biologic products. International J Toxicol 16:33-40
-
(1997)
International J Toxicol
, vol.16
, pp. 33-40
-
-
Green, M.D.1
-
13
-
-
79952771693
-
Mechanisms of drug toxicity and relevance to pharmaceutical development
-
Guengerich FP (2011) Mechanisms of drug toxicity and relevance to pharmaceutical development. Drug Metab Pharmacokinet 26:3-14
-
(2011)
Drug Metab Pharmacokinet
, vol.26
, pp. 3-14
-
-
Guengerich, F.P.1
-
14
-
-
68749109281
-
Comparison of electrocardiographic analysis for risk of qt interval prolongation using safety pharmacology and toxicology studies
-
Guth BD, Bass AS, Briscoe R, Chivers S, Markert M, Siegl PKS, Valentin JP (2009) Comparison of electrocardiographic analysis for risk of QT interval prolongation using safety pharmacology and toxicology studies. J Pharmacol Toxicol Methods 60:107-116
-
(2009)
J Pharmacol Toxicol Methods
, vol.60
, pp. 107-116
-
-
Guth, B.D.1
Bass, A.S.2
Briscoe, R.3
Chivers, S.4
Markert, M.5
Siegl, P.6
Valentin, J.P.7
-
17
-
-
84955370025
-
Nonclinical evaluation of the potential for delayed ventricular repolarization
-
Retrieved February 2012 from
-
ICH S7B (2005) Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT interval prolongation) by Human Biopharmaceuticals. Retrieved February 2012 from http://www.ich.org.
-
(2005)
(QT Interval Prolongation) by Human Biopharmaceuticals
-
-
-
18
-
-
78649857382
-
Measurement of respiratory function using whole-body plethysmography in unanesthetized and unrestrained non-human primates
-
Iizuka H, Sasaki K, Odagiri N, Obo M, Imaizumi M, Atai H (2010) Measurement of respiratory function using whole-body plethysmography in unanesthetized and unrestrained non-human primates. J Toxicol Sci 35:863-870
-
(2010)
J Toxicol Sci
, vol.35
, pp. 863-870
-
-
Iizuka, H.1
Sasaki, K.2
Odagiri, N.3
Obo, M.4
Imaizumi, M.5
Atai, H.6
-
19
-
-
84871501088
-
Integration of cardiovascular safety pharmacology endpoints into general toxicology studies
-
Kaiser RA, Erwin R, Tichenor SD, Regalia DE, Meyer DJ (2010) Integration of cardiovascular safety pharmacology endpoints into general toxicology studies. J Pharmacol Toxicol Methods 62:e30
-
(2010)
J Pharmacol Toxicol Methods
, pp. 62
-
-
Kaiser, R.A.1
Erwin, R.2
Tichenor, S.D.3
Regalia, D.E.4
Meyer, D.J.5
-
20
-
-
84857366692
-
Modified irwin test as diagnostic tool to monitor neurobehavioral changes in monkeys
-
Korte S, Fuchs A, Weinbauer GF, Moscardo E, Giarola A (2007) Modified Irwin test as diagnostic tool to monitor neurobehavioral changes in monkeys. J Pharmacol Toxicol Methods 56:e47
-
(2007)
J Pharmacol Toxicol Methods
, pp. 56
-
-
Korte, S.1
Fuchs, A.2
Weinbauer, G.F.3
Moscardo, E.4
Giarola, A.5
-
21
-
-
13144251108
-
Recommendations for blood pressure measurement in humans and animals
-
Kurtz TW, Griffin KA, Bidani AK, Davisson RL, Hall JE (2005) Recommendations for blood pressure measurement in humans and animals. Hypertension 45:299-310
-
(2005)
Hypertension
, vol.45
, pp. 299-310
-
-
Kurtz, T.W.1
Griffin, K.A.2
Bidani, A.K.3
Davisson, R.L.4
Hall, J.E.5
-
22
-
-
37749004225
-
Protein therapeutics: A summary and pharmacological classification
-
Leader B, Baca QJ, Golan DE (2008) Protein therapeutics: a summary and pharmacological classification. Nature Reviews 7:21-39
-
(2008)
Nature Reviews
, vol.7
, pp. 21-39
-
-
Leader, B.1
Baca, Q.J.2
Golan, D.E.3
-
23
-
-
34548411390
-
Biopharmaceuticals and the future of the pharmaceutical industry
-
Lowe JA, Jones P (2007) Biopharmaceuticals and the future of the pharmaceutical industry. Cur Opin Drug Disc Develop 10:513-514
-
(2007)
Cur Opin Drug Disc Develop
, vol.10
, pp. 513-514
-
-
Lowe, J.A.1
Jones, P.2
-
24
-
-
77956045289
-
Evaluation of blood pressure measurement using a miniature blood pressure transmitter with jacketed external telemetry in cynomolgus monkeys
-
McMahon C, Mitchell AZ, Klein JL, Jenkins AC, Sarazan RD (2010) Evaluation of blood pressure measurement using a miniature blood pressure transmitter with jacketed external telemetry in cynomolgus monkeys. J Pharmacol Toxicol Methods 62:127-135
-
(2010)
J Pharmacol Toxicol Methods
, vol.62
, pp. 127-135
-
-
Mc Mahon, C.1
Mitchell, A.Z.2
Klein, J.L.3
Jenkins, A.C.4
Sarazan, R.D.5
-
25
-
-
48849101132
-
Safety assessment of biopharmaceuticals: Japanese perspective on ich s6 guideline maintenance
-
Nakazawa T, Kurokawa KK, Wakata A, Hisada S, Inoue T, Sagami F, Heidel SM, Kawakami K, Shinoda K, Onodera H, Kumagai Y, Ohno Y, Kawamura N, Yamazaki T, Inoue T (2008) Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance. J Toxicol Sci 33:277-282
-
(2008)
J Toxicol Sci
, vol.33
, pp. 277-282
-
-
Nakazawa, T.1
Kurokawa, K.K.2
Wakata, A.3
Hisada, S.4
Inoue, T.5
Sagami, F.6
Heidel, S.M.7
Kawakami, K.8
Shinoda, K.9
Onodera, H.10
Kumagai, Y.11
Ohno, Y.12
Kawamura, N.13
Yamazaki, T.14
Inoue, T.15
-
26
-
-
12344273726
-
The blood brain barrier: Bottleneck in brain drug development
-
Pardridge WM (2005) The blood brain barrier: bottleneck in brain drug development. Neurorx 2:3-14
-
(2005)
Neurorx
, vol.2
, pp. 3-14
-
-
Pardridge, W.M.1
-
27
-
-
79953020046
-
Bekm-1, a peptide inhibitor of herg potassium currents, prolongs qtc interval in isolated rabbit hearts
-
Qu Y, Fang M, Gao B, Chui RW, Vargas HM (2011) BeKm-1, a peptide inhibitor of hERG potassium currents, prolongs QTc interval in isolated rabbit hearts. J Pharmacol Exp Ther 337:2-8
-
(2011)
J Pharmacol Exp Ther
, vol.337
, pp. 2-8
-
-
Qu, Y.1
Fang, M.2
Gao, B.3
Chui, R.W.4
Vargas, H.M.5
-
28
-
-
84866002377
-
Off-target platelet activation in macaques unique to a therapeutic monoclonal antibody
-
press
-
Santostefano MJ, Kirchner J, Vissinga C, Fort M, Lear S, Pan W-J, Prince PJ, Hensley KM, Tran D, Rock D, Vargas HM, Narayanan P, Jawando R, Rees W, Reindel JF, Reynhardt K, Everds N (2012) Off-target platelet activation in macaques unique to a therapeutic monoclonal antibody. Toxicol Sci (in press)
-
(2012)
Toxicol Sci
-
-
Santostefano, M.J.1
Kirchner, J.2
Vissinga, C.3
Fort, M.4
Lear, S.5
Pan, W.-J.6
Prince, P.J.7
Hensley, K.M.8
Tran, D.9
Rock, D.10
Vargas, H.M.11
Narayanan, P.12
Jawando, R.13
Rees, W.14
Reindel, J.F.15
Reynhardt, K.16
Everds, N.17
-
29
-
-
70149118346
-
High-definition oscillometry: A novel technique for non-invasive blood pressure monitoring in the cynomolgus monkey
-
Schmelting B, Neihoff M, Egner B, Korte SH, Weinbauer GF (2009) High-definition oscillometry: a novel technique for non-invasive blood pressure monitoring in the cynomolgus monkey. J Med Primatol. 38(5):293-301
-
(2009)
J Med Primatol
, vol.38
, Issue.5
, pp. 293-301
-
-
Schmelting, B.1
Neihoff, M.2
Egner, B.3
Korte, S.H.4
Weinbauer, G.F.5
-
30
-
-
33748750980
-
Regulating biopharmaceuticals under cder versus cber: An insider’s perspective
-
Schwieterman WD (2006) Regulating biopharmaceuticals under CDER versus CBER: an insider’s perspective. Drug Disc Today 11:945-951
-
(2006)
Drug Disc Today
, vol.11
, pp. 945-951
-
-
Schwieterman, W.D.1
-
31
-
-
32444438731
-
Elimination mechanisms of therapeutic monoclonal antibodies
-
Tabrizi MA, Tseng CML, Roskos LK (2006) Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discovery Today 11:81-88
-
(2006)
Drug Discovery Today
, vol.11
, pp. 81-88
-
-
Tabrizi, M.A.1
Tseng, C.2
Roskos, L.K.3
-
32
-
-
48149092512
-
Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics
-
Vargas HM, Bass AS, Breidenbach A, Feldman HS, Gintant GA, Harmer A, Heath B, Hoffmann P, Lagrutta A, Leishmann D, McMahon N, Mittelstadt SW, Polonchuk L, Pugsley MK, Salata JJ, Valentin JP (2008) Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics. J Pharmacol Toxicol Methods 58:72-76
-
(2008)
J Pharmacol Toxicol Methods
, vol.58
, pp. 72-76
-
-
Vargas, H.M.1
Bass, A.S.2
Breidenbach, A.3
Feldman, H.S.4
Gintant, G.A.5
Harmer, A.6
Heath, B.7
Hoffmann, P.8
Lagrutta, A.9
Leishmann, D.10
Mc Mahon, N.11
Mittelstadt, S.W.12
Polonchuk, L.13
Pugsley, M.K.14
Salata, J.J.15
Valentin, J.P.16
-
33
-
-
84871482350
-
Evaluation of d, l-sotalol using jacketed external telemetry (Jet) in conscious non-human primates over 4 weeks of evaluation
-
Vargas HM, Derakhchan K, Chui RW, Stevens DW (2010) Evaluation of D, L-sotalol using jacketed external telemetry (JET) in conscious non-human primates over 4 weeks of evaluation. J Pharmacol Toxicol Methods 64:e24-e25
-
(2010)
J Pharmacol Toxicol Methods
, vol.64
-
-
Vargas, H.M.1
Derakhchan, K.2
Chui, R.W.3
Stevens, D.W.4
-
34
-
-
84859380363
-
Comparison of arterial blood pressure measurements and hypertension scores obtained by use of three indirect measurement devices in hospitalized dogs
-
Wernick MB, Hopfner RM, Francey T, Howard J (2012) Comparison of arterial blood pressure measurements and hypertension scores obtained by use of three indirect measurement devices in hospitalized dogs. J Am Vet Med Assoc 240:962-968
-
(2012)
J am Vet Med Assoc
, vol.240
, pp. 962-968
-
-
Wernick, M.B.1
Hopfner, R.M.2
Francey, T.3
Howard, J.4
|