-
1
-
-
35748931888
-
Intermolecular interactions and biological pathways
-
Baxevanis AD, Ouellette BFF Eds, 3rd Edition. Hoboken, NJ: Wiley
-
Bader GD, Enright AJ, 2005, Intermolecular interactions and biological pathways. In Baxevanis AD, Ouellette BFF (Eds), Bioinformatics: A Practical Guide to the Analysis of Genes and Proteins, 3rd Edition. Hoboken, NJ: Wiley.
-
(2005)
Bioinformatics: A Practical Guide to the Analysis of Genes and Proteins
-
-
Bader, G.D.1
Enright, A.J.2
-
2
-
-
34547752433
-
Cardiovascular safety of drugs not intended for cardiovascular use: Need for a new conceptual basis for assessment and approval
-
Borer JS, Pouleur H, Abadie E, et al., 2007, Cardiovascular safety of drugs not intended for cardiovascular use: Need for a new conceptual basis for assessment and approval. European Heart Journal, 28:1904-1909.
-
(2007)
European Heart Journal
, vol.28
, pp. 1904-1909
-
-
Borer, J.S.1
Pouleur, H.2
Abadie, E.3
-
3
-
-
33644551182
-
Risk assessment in drug development for symptomatic indications: A framework for the prospective exclusion of unacceptable cardiovascular risk
-
Brass EP, Lewis RJ, Lipicky R, Murphy J, Hiatt WR, 2006, Risk assessment in drug development for symptomatic indications: A framework for the prospective exclusion of unacceptable cardiovascular risk. Clinical Pharmacology and Therapeutics, 75:165-172.
-
(2006)
Clinical Pharmacology and Therapeutics
, vol.75
, pp. 165-172
-
-
Brass, E.P.1
Lewis, R.J.2
Lipicky, R.3
Murphy, J.4
Hiatt, W.R.5
-
4
-
-
84882508776
-
Blinding of drug products
-
Monkhouse DC, Carney CF, Clark JL Eds, 2nd Edition. Boca Raton: Taylor & Francis
-
Brun P, 2006, Blinding of drug products. In Monkhouse DC, Carney CF, Clark JL (Eds), Drug Products for Clinical Trials, 2nd Edition. Boca Raton: Taylor & Francis, 149-172.
-
(2006)
Drug Products for Clinical Trials
, pp. 149-172
-
-
Brun, P.1
-
6
-
-
84900955123
-
Patient recruitment: Are we looking in the right place?
-
Summer issue
-
Cabell C, 2009, Patient recruitment: Are we looking in the right place? International Pharmaceutical Industry, Summer issue, 38-41.
-
(2009)
International Pharmaceutical Industry
, pp. 38-41
-
-
Cabell, C.1
-
8
-
-
84900974318
-
Assessing cardiovascular safety during the development of new antidiabetic therapies for Type 2 diabetes: A review of FDA guidance
-
December issue
-
Caveney E, Turner JR, 2009, Assessing cardiovascular safety during the development of new antidiabetic therapies for Type 2 diabetes: A review of FDA guidance. DIA Global Forum, December issue, 42-45.
-
(2009)
DIA Global Forum
, pp. 42-45
-
-
Caveney, E.1
Turner, J.R.2
-
9
-
-
79954999582
-
Regulatory landscapes for future antidiabetic drug development (Part I): FDA guidance on assessment of cardiovascular risks
-
January issue
-
Caveney E, Turner JR, 2010, Regulatory landscapes for future antidiabetic drug development (Part I): FDA guidance on assessment of cardiovascular risks. Journal for Clinical Studies, January issue, 34-36.
-
(2010)
Journal for Clinical Studies
, pp. 34-36
-
-
Caveney, E.1
Turner, J.R.2
-
12
-
-
0004293330
-
-
2nd Edition. Washington, DC: American Pharmacists Association
-
Cohen MR (Ed), 2007, Medication Errors, 2nd Edition. Washington, DC: American Pharmacists Association.
-
(2007)
Medication Errors
-
-
Cohen, M.R.1
-
13
-
-
37849022052
-
Preparing for first-in-man studies: The challenges for translational immunology post-TGN1412
-
Dayan CM, Wraith DC, 2008, Preparing for first-in-man studies: The challenges for translational immunology post-TGN1412. Clinical and Experimental Immunology, 151:231-234.
-
(2008)
Clinical and Experimental Immunology
, vol.151
, pp. 231-234
-
-
Dayan, C.M.1
Wraith, D.C.2
-
14
-
-
58149114125
-
Pharmacological and regulatory aspects of QT prolongation
-
Vaz RJ, Klabunde T Eds, Weinheim, Germany: Wiley-VCH
-
De Ponti F, 2008, Pharmacological and regulatory aspects of QT prolongation. In Vaz RJ, Klabunde T (Eds), Antitargets: Prediction and Prevention of Drug Side Effects. Weinheim, Germany: Wiley-VCH.
-
(2008)
Antitargets: Prediction and Prevention of Drug Side Effects
-
-
De Ponti, F.1
-
16
-
-
35848930559
-
Perspective: Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death
-
Diamond GA, Bax L, Kaul S, 2007, Perspective: Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Annals of Internal Medicine, 147:578-581.
-
(2007)
Annals of Internal Medicine
, vol.147
, pp. 578-581
-
-
Diamond, G.A.1
Bax, L.2
Kaul, S.3
-
19
-
-
84889875556
-
Cardiac arrhythmia assessments in Phase IV clinical studies
-
Morganroth JM, Gussak I Eds, Totowa, NJ: Humana Press
-
Faich GA, Stemhagen A, 2005, Cardiac arrhythmia assessments in Phase IV clinical studies. In Morganroth JM, Gussak I (Eds), Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development. Totowa, NJ: Humana Press, 229-237.
-
(2005)
Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development
, pp. 229-237
-
-
Faich, G.A.1
Stemhagen, A.2
-
23
-
-
0004008434
-
-
3rd Edition. New York, NY: Springer
-
Friedman LK, Furberg CD, De Mets DL, 1998, Fundamentals of Clinical Trials, 3rd Edition. New York, NY: Springer
-
(1998)
Fundamentals of Clinical Trials
-
-
Friedman, L.K.1
Furberg, C.D.2
De Mets, D.L.3
-
25
-
-
0002211880
-
Estimation rather than hypothesis testing: Confidence intervals rather than p-values
-
Gardner MJ, Altman DG Eds, London: British Medical Association
-
Gardner MJ, Altman DG, 1986, Estimation rather than hypothesis testing: Confidence intervals rather than p-values. In Gardner MJ, Altman DG (Eds), Statistics with Confidence. London: British Medical Association.
-
(1986)
Statistics with Confidence
-
-
Gardner, M.J.1
Altman, D.G.2
-
27
-
-
59849096026
-
Standard Operating Procedures (SOPs): Why companies must have them, and why they need them
-
Gough J, Hamrell M, 2009, Standard Operating Procedures (SOPs): Why companies must have them, and why they need them. Drug Information Journal, 43:69-74.
-
(2009)
Drug Information Journal
, vol.43
, pp. 69-74
-
-
Gough, J.1
Hamrell, M.2
-
28
-
-
77954940488
-
Standard Operating Procedures (SOPs): How companies can determine which documents they must put in place
-
Gough J, Hamrell M, 2010, Standard Operating Procedures (SOPs): how companies can determine which documents they must put in place. Drug Information Journal, 44:49-54.
-
(2010)
Drug Information Journal
, vol.44
, pp. 49-54
-
-
Gough, J.1
Hamrell, M.2
-
29
-
-
51749121671
-
Proteomics and protein identification
-
Baxevanis AD, Ouellette BFF Eds, 3rd Edition. Hoboken, NJ: Wiley-Interscience
-
Holmes MR, Ramkissoon KR, Giddings MC, 2005, Proteomics and protein identification. In Baxevanis AD, Ouellette BFF (Eds), Bioinformatics: A Practical Guide to the Analysis of Genes and Proteins, 3rd Edition. Hoboken, NJ: Wiley-Interscience, 445-572.
-
(2005)
Bioinformatics: A Practical Guide to the Analysis of Genes and Proteins
, pp. 445-572
-
-
Holmes, M.R.1
Ramkissoon, K.R.2
Giddings, M.C.3
-
30
-
-
84900948996
-
Interim analysis and adaptive design in clinical trials
-
Buncher CR, Tsay J-Y Eds, 3rd Edition. Boca Raton: Chapman & Hall/CRC
-
Hwang IK, Lan KKG, 2006, Interim analysis and adaptive design in clinical trials. In Buncher CR, Tsay J-Y (Eds), Statistics in the Pharmaceutical Industry, 3rd Edition. Boca Raton: Chapman & Hall/CRC, 245-284.
-
(2006)
Statistics in the Pharmaceutical Industry
, pp. 245-284
-
-
Hwang, I.K.1
Lan, K.K.G.2
-
32
-
-
33750328584
-
-
Institute of Medicine of the National Academies, Washington, DC: National Academies Press
-
Institute of Medicine of the National Academies, 2007b, Preventing Medication Errors. Washington, DC: National Academies Press.
-
(2007)
Preventing Medication Errors
-
-
-
33
-
-
84900945680
-
Patient recruitment and retention in clinical trials
-
Spring issue
-
Jaishankar R, 2009, Patient recruitment and retention in clinical trials. International Pharmaceutical Industry, Spring issue, 26-28.
-
(2009)
International Pharmaceutical Industry
, pp. 26-28
-
-
Jaishankar, R.1
-
34
-
-
85057684969
-
Historical aspects of pharmacogenetics
-
Kalow W, Meyer UA, Tyndale RF Eds, 2nd Edition. Boca Raton: Taylor & Francis
-
Kalow W, 2005, Historical aspects of pharmacogenetics. In Kalow W, Meyer UA, Tyndale RF (Eds), Pharmacogenomics, 2nd Edition. Boca Raton: Taylor & Francis, 1-11.
-
(2005)
Pharmacogenomics
, pp. 1-11
-
-
Kalow, W.1
-
35
-
-
0002859079
-
Hypertension in Framingham
-
Paul O Ed, New York: Grune & Stratton/Intercontinental Medical Book Corporation
-
Kannel WB, Sorlie P, 1975, Hypertension in Framingham. In Paul O (Ed), Epidemiology and Control of Hypertension. New York: Grune & Stratton/Intercontinental Medical Book Corporation.
-
(1975)
Epidemiology and Control of Hypertension
-
-
Kannel, W.B.1
Sorlie, P.2
-
41
-
-
0842276015
-
Introduction to pharmacogenomics: Promises, opportunities, and limitations
-
Licinio J, Wong M-L Eds, Manheim, Germany: Wiley-VCH
-
Meyer UA, 2002, Introduction to pharmacogenomics: Promises, opportunities, and limitations. In Licinio J, Wong M-L (Eds), Pharmacogenomics: The Search for Individualized Therapies. Manheim, Germany: Wiley-VCH, 1-8.
-
(2002)
Pharmacogenomics: The Search for Individualized Therapies
, pp. 1-8
-
-
Meyer, U.A.1
-
42
-
-
84900942470
-
Common technical document: The changing face of the new drug application
-
Smith CG, O'Donnell JT Eds, 2nd Edition, New York, NY: Informa Healthcare
-
Molzon JA, 2006, Common technical document: The changing face of the new drug application. In Smith CG, O'Donnell JT (Eds), The Process of New Drug Discovery and Development, 2nd Edition, New York, NY: Informa Healthcare, 473-479.
-
(2006)
The Process of New Drug Discovery and Development
, pp. 473-479
-
-
Molzon, J.A.1
-
43
-
-
84882467384
-
The clinical trials material professional: A changing role
-
Monkhouse DC, Carney CF, Clark JL Eds, 2nd Edition. Boca Raton: Taylor & Francis
-
Monkhouse DC, 2006a, The clinical trials material professional: A changing role. In Monkhouse DC, Carney CF, Clark JL (Eds), Drug Products for Clinical Trials, 2nd Edition. Boca Raton: Taylor & Francis, 1-19.
-
(2006)
Drug Products for Clinical Trials
, pp. 1-19
-
-
Monkhouse, D.C.1
-
44
-
-
84889802754
-
Manufacturing and clinical medicine trends for the clinical trials material professional
-
Monkhouse DC, Carney CF, Clark JL Eds, 2nd Edition. Boca Raton: Taylor & Francis
-
Monkhouse DC, 2006b, Manufacturing and clinical medicine trends for the clinical trials material professional. In Monkhouse DC, Carney CF, Clark JL (Eds), Drug Products for Clinical Trials, 2nd Edition. Boca Raton: Taylor & Francis, 21-68.
-
(2006)
Drug Products for Clinical Trials
, pp. 21-68
-
-
Monkhouse, D.C.1
-
45
-
-
0025825919
-
Variability of the QT measurement in health men: With implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia
-
Morganroth J, Brozovich FV, McDonald JT, Jacobs RA, 1991, Variability of the QT measurement in health men: With implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia. American Journal of Cardiology, 67:774-776.
-
(1991)
American Journal of Cardiology
, vol.67
, pp. 774-776
-
-
Morganroth, J.1
Brozovich, F.V.2
McDonald, J.T.3
Jacobs, R.A.4
-
46
-
-
0038314757
-
-
National Institutes of Health, Department of Health and Human Services, NIH Publication No. 04-5230
-
National Institutes of Health, Department of Health and Human Services, 2004, The seventh report of the Joint National Committee [JNC 7] on prevention, detection, evaluation, and treatment of high blood pressure. NIH Publication No. 04-5230.
-
(2004)
The Seventh Report of the Joint National Committee [JNC 7] on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure
-
-
-
47
-
-
34250212715
-
Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
-
Nissen SE, Wolski K, 2007, Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. New England Journal of Medicine, 356:2, 457-2, 471.
-
(2007)
New England Journal of Medicine
, vol.356
, pp. 2457-2471
-
-
Nissen, S.E.1
Wolski, K.2
-
48
-
-
84889793969
-
Surrogate endpoints
-
Wilkins MR Ed, Boca Raton: Martin Dunitz/Taylor & Francis Group
-
Oliver JJ, Webb DJ, 2003, Surrogate endpoints. In Wilkins MR (Ed), Experimental Therapeutics. Boca Raton: Martin Dunitz/Taylor & Francis Group, 145-165.
-
(2003)
Experimental Therapeutics
, pp. 145-165
-
-
Oliver, J.J.1
Webb, D.J.2
-
49
-
-
79958000901
-
Pharmacovigilance
-
Mulder GJ, Dencker L Eds, London: Pharmaceutical Press
-
Olsson S, Meyboom R, 2006, Pharmacovigilance. In Mulder GJ, Dencker L (Eds), Pharmaceutical Toxicology. London: Pharmaceutical Press.
-
(2006)
Pharmaceutical Toxicology
-
-
Olsson, S.1
Meyboom, R.2
-
53
-
-
64349093768
-
Assessing proarrhythmic potential of drugs when optimal studies are infeasible
-
Rock EP, Finkle J, Fingert HJ, et al., 2009, Assessing proarrhythmic potential of drugs when optimal studies are infeasible. American Heart Journal, 157:827-836.
-
(2009)
American Heart Journal
, vol.157
, pp. 827-836
-
-
Rock, E.P.1
Finkle, J.2
Fingert, H.J.3
-
55
-
-
36448970843
-
Cardiac repolarization and drug regulation: Assessing cardiac safety 10 years after the CPMP guidance
-
Shah RR, 2007, Cardiac repolarization and drug regulation: Assessing cardiac safety 10 years after the CPMP guidance. Drug Safety, 30:1, 093-1, 110.
-
(2007)
Drug Safety
, vol.30
, pp. 1093-1110
-
-
Shah, R.R.1
-
56
-
-
84900942455
-
Chip-based proteomics technology
-
Rapley F, Harbron S Eds, Hoboken, NJ: Wiley
-
Soloviev M, Barry R, Terrett J, 2004, Chip-based proteomics technology. In Rapley F, Harbron S (Eds), Molecular Analysis and Genome Discovery. Hoboken, NJ: Wiley.
-
(2004)
Molecular Analysis and Genome Discovery
-
-
Soloviev, M.1
Barry, R.2
Terrett, J.3
-
59
-
-
84900934489
-
Stability studies of pharmaceuticals
-
Buncher CR, Tsay J-Y Eds, 3rd Edition. Roca Raton: Chapman & Hall/CRC
-
Tsong Y, Chen C-W, Chen WJ, et al., 2006, Stability studies of pharmaceuticals. In Buncher CR, Tsay J-Y (Eds), Statistics in the Pharmaceutical Industry, 3rd Edition. Roca Raton: Chapman & Hall/CRC, 391-419.
-
(2006)
Statistics in the Pharmaceutical Industry
, pp. 391-419
-
-
Tsong, Y.1
Chen, C.-W.2
Chen, W.J.3
-
60
-
-
77958189976
-
Interpreting the interval: The design, methodology, analysis, and interpretation of the ICH E14 thorough QT/QTc study
-
September issue
-
Turner JR, 2009a, Interpreting the interval: The design, methodology, analysis, and interpretation of the ICH E14 thorough QT/QTc study. European Pharmaceutical Contractor, September issue, 84-86.
-
(2009)
European Pharmaceutical Contractor
, pp. 84-86
-
-
Turner, J.R.1
-
61
-
-
77958158281
-
Drug safety, medication safety, patient safety: An overview of recent FDA initiatives and guidances
-
April issue
-
Turner JR, 2009b, Drug safety, medication safety, patient safety: An overview of recent FDA initiatives and guidances. Regulatory Rapporteur, April issue, 4-8.
-
(2009)
Regulatory Rapporteur
, pp. 4-8
-
-
Turner, J.R.1
-
62
-
-
84871937240
-
Integrated cardiovascular safety: Expanding our assessment horizons for prospectively excluding unacceptable cardiovascular risks
-
June issue
-
Turner JR, 2010, Integrated cardiovascular safety: Expanding our assessment horizons for prospectively excluding unacceptable cardiovascular risks. Applied Clinical Trials, June issue, 76-79.
-
(2010)
Applied Clinical Trials
, pp. 76-79
-
-
Turner, J.R.1
-
63
-
-
79954996608
-
Regulatory landscapes for future antidiabetic drug development (Part II): EMA Guidance on Assessment of Cardiovascular Risks
-
March issue
-
Turner JR, Caveney S, 2010, Regulatory landscapes for future antidiabetic drug development (Part II): EMA Guidance on Assessment of Cardiovascular Risks, Journal for Clinical Studies, March issue, 38-40.
-
(2010)
Journal for Clinical Studies
, pp. 38-40
-
-
Turner, J.R.1
Caveney, S.2
-
64
-
-
77958166874
-
Making sense of biostatistics: Assessing drug cardiac safety
-
Turner JR, Satin L, 2009, Making sense of biostatistics: Assessing drug cardiac safety. Journal of Clinical Research Best Practices, May issue. [See http://firstclinical.com/journal/2009/0905-Biostatistics9.pdf]
-
(2009)
Journal of Clinical Research Best Practices
-
-
Turner, J.R.1
Satin, L.2
-
65
-
-
84900951754
-
Case report form development
-
Schuster DP, powers WJ Eds, Philadelphia: Lippincott Williams & Wilkins
-
Voorhees J, Scheipeter ME, 2005, Case report form development. In Schuster DP, powers WJ (Eds), Translational and Experimental Clinical Research. Philadelphia: Lippincott Williams & Wilkins, 122-135.
-
(2005)
Translational and Experimental Clinical Research
, pp. 122-135
-
-
Voorhees, J.1
Scheipeter, M.E.2
-
71
-
-
84884309043
-
-
Weinheim, Germany: Wiley-VCH
-
Tobin JJ, Walsh G, 2008, Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, and Medical Devices. Weinheim, Germany: Wiley-VCH.
-
(2008)
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, and Medical Devices
-
-
Tobin, J.J.1
Walsh, G.2
-
74
-
-
84889817980
-
-
Hoboken, NJ: Wiley
-
Ekins S, Xu JJ, 2009, Drug Efficacy, Safety, and Biologics Discovery: Emerging Technologies and Tools. Hoboken, NJ: Wiley.
-
(2009)
Drug Efficacy, Safety, and Biologics Discovery: Emerging Technologies and Tools
-
-
Ekins, S.1
Xu, J.J.2
-
76
-
-
84876534433
-
-
Hoboken, NJ: Wiley
-
Han C, Davis CB, Wang B (Eds), 2010, Evaluation of Drug Candidates for Preclinical Development: Pharmacokinetics, Metabolism, Pharmaceutics, and Toxicology. Hoboken, NJ: Wiley.
-
(2010)
Evaluation of Drug Candidates for Preclinical Development: Pharmacokinetics, Metabolism, Pharmaceutics, and Toxicology
-
-
Han, C.1
Davis, C.B.2
Wang, B.3
-
82
-
-
0004008434
-
-
3rd Edition. New York, NY: Springer
-
Friedman LM, Furberg CD, De Mets DL, 2009, Fundamentals of Clinical Trials, 3rd Edition. New York, NY: Springer.
-
(2009)
Fundamentals of Clinical Trials
-
-
Friedman, L.M.1
Furberg, C.D.2
De Mets, D.L.3
-
83
-
-
84890638266
-
-
2nd Edition. Chichester, UK: Wiley
-
Machin D, Day S, Green S (Eds), 2006, Textbook of Clinical Trials, 2nd Edition. Chichester, UK: Wiley.
-
(2006)
Textbook of Clinical Trials
-
-
Machin, D.1
Day, S.2
Green, S.3
-
85
-
-
84890484506
-
-
Chichester, UK: Wiley
-
Abdel-aleem SM, 2010, The Design and Management of Medical Device Clinical Trials: Strategies and Challenges. Chichester, UK: Wiley. [While this book focuses on clinical trials of medical devices rather than of drugs, much of its content is highly relevant to drug trials. Issues such as developing protocols, standard operating procedures, site and Principal Investigator selection, subject selection, subject compliance, data management and data analysis are germane in both types of trials.]
-
(2010)
The Design and Management of Medical Device Clinical Trials: Strategies and Challenges
-
-
Abdel-aleem, S.M.1
-
89
-
-
77249119567
-
-
Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins
-
Spilker B, 2009, Guide to Drug Development: A Comprehensive Review and Assessment. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins [Note: This is a comprehensive book (1277 pages) on the process of drug development. I would like to acknowledge that I have drawn from several of its chapters in the preparation of this chapter.]
-
(2009)
Guide to Drug Development: A Comprehensive Review and Assessment
-
-
Spilker, B.1
-
94
-
-
84891576608
-
-
2nd Edition. Hoboken, NJ: Wiley
-
Gad SC (Ed), 2009, Drug Safety Evaluation, 2nd Edition. Hoboken, NJ: Wiley.
-
(2009)
Drug Safety Evaluation
-
-
Gad, S.C.1
-
95
-
-
77958158281
-
Drug safety, medication safety, patient safety: An overview of recent FDA guidances and initiatives
-
April issue
-
Turner JR, 2009, Drug safety, medication safety, patient safety: An overview of recent FDA guidances and initiatives. Regulatory Rapporteur, April issue, 4-8.
-
(2009)
Regulatory Rapporteur
, pp. 4-8
-
-
Turner, J.R.1
-
100
-
-
70049099675
-
Design and analysis considerations for thorough QT studies employing conventional (10s, 12-lead) ECG recordings
-
Beasley CM Jr, Dmitrienko A, Mitchell MI, 2008, Design and analysis considerations for thorough QT studies employing conventional (10s, 12-lead) ECG recordings, Expert Review in Clinical Pharmacology, 1:815-839.
-
(2008)
Expert Review in Clinical Pharmacology
, vol.1
, pp. 815-839
-
-
Beasley Jr., C.M.1
Dmitrienko, A.2
Mitchell, M.I.3
-
101
-
-
79954999582
-
Regulatory landscapes for future antidiabetic drug development (Part I): FDA guidance on assessment of cardiovascular risk
-
January issue
-
Caveney E, Turner JR, 2010, Regulatory landscapes for future antidiabetic drug development (Part I): FDA guidance on assessment of cardiovascular risk. Journal for Clinical Studies, January issue, 34-36.
-
(2010)
Journal for Clinical Studies
, pp. 34-36
-
-
Caveney, E.1
Turner, J.R.2
-
102
-
-
84889827704
-
-
Hoboken, NJ: Wiley
-
Turner JR, Durham, 2009, Integrated Cardiac Safety: Assessment Methodologies for Non-cardiac Drugs in Discovery, Development, and Postmarketing Surveillance. Hoboken, NJ: Wiley.
-
(2009)
Integrated Cardiac Safety: Assessment Methodologies for Non-cardiac Drugs in Discovery, Development, and Postmarketing Surveillance
-
-
Turner, J.R.1
Durham2
-
103
-
-
74549216361
-
Update on the evaluation of a new drug for effects on cardiac repolarization in humans: Issues in early drug development
-
Vaibhav S, Karnard DR, Panicker GP, Kothari S, 2009, Update on the evaluation of a new drug for effects on cardiac repolarization in humans: Issues in early drug development. British Journal of Pharmacology, 159:34-38.
-
(2009)
British Journal of Pharmacology
, vol.159
, pp. 34-38
-
-
Vaibhav, S.1
Karnard, D.R.2
Panicker, G.P.3
Kothari, S.4
-
109
-
-
72149102353
-
-
Medicines and Healthcare Products Regulatory Agency MHRA, London: Pharmaceutical Press
-
Medicines and Healthcare Products Regulatory Agency (MHRA), 2009, Good Pharmacovigilance Practice Guide. London: Pharmaceutical Press.
-
(2009)
Good Pharmacovigilance Practice Guide
-
-
|