-
2
-
-
11844258149
-
-
2nd edn (John Wiley & Sons, Hoboken, New Jersey)
-
Ng, R. Drugs. From discovery to approval 2nd edn (John Wiley & Sons, Hoboken, New Jersey, 2009).
-
(2009)
Drugs. From Discovery to Approval
-
-
Ng, R.1
-
3
-
-
44249085898
-
-
1st edn (Churchill Livingstone, Elsevier, Philadelphia)
-
Rang, H. P. Drug Discovery and Development. 1st edn (Churchill Livingstone, Elsevier, Philadelphia, 2007).
-
(2007)
Drug Discovery and Development
-
-
Rang, H.P.1
-
4
-
-
0036750745
-
Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999
-
Cross, J. et al. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Pharmacoepidemiol. Drug Saf. 11 , 439-446 (2002).
-
(2002)
Pharmacoepidemiol. Drug Saf.
, vol.11
, pp. 439-446
-
-
Cross, J.1
-
5
-
-
33744922424
-
TGN1412: Time to change the paradigm for the testing of new pharmaceuticals
-
Bhogal, N. & Combes, R. TGN1412: time to change the paradigm for the testing of new pharmaceuticals. Altern. Lab. Anim. 34, 225-239 (2006).
-
(2006)
Altern. Lab. Anim.
, vol.34
, pp. 225-239
-
-
Bhogal, N.1
Combes, R.2
-
6
-
-
12144287356
-
Raising high-density lipoprotein in humans through inhibition of cholesteryl ester transfer protein: An initial multidose study of torcetrapib
-
Clark, R. W. et al. Raising high-density lipoprotein in humans through inhibition of cholesteryl ester transfer protein: an initial multidose study of torcetrapib. Arterioscler. Thromb. Vasc. Biol. 24, 490-497 (2004).
-
(2004)
Arterioscler. Thromb. Vasc. Biol.
, vol.24
, pp. 490-497
-
-
Clark, R.W.1
-
7
-
-
67349279795
-
A translational medicine perspective of the development of torcetrapib: Does the failure of torcetrapib development cast a shadow on future development of lipid modifying agents, HDL elevation strategies or CETP as a viable molecular target for atherosclerosis? A case study of the use of biomarkers and translational medicine in atherosclerosis drug discovery and development
-
Zhao, L., Jin, W., Rader, D., Packard, C. & Feuerstein, G. A translational medicine perspective of the development of torcetrapib: does the failure of torcetrapib development cast a shadow on future development of lipid modifying agents, HDL elevation strategies or CETP as a viable molecular target for atherosclerosis? A case study of the use of biomarkers and translational medicine in atherosclerosis drug discovery and development. Biochem. Pharmacol. 78, 315-325 (2009).
-
(2009)
Biochem. Pharmacol.
, vol.78
, pp. 315-325
-
-
Zhao, L.1
Jin, W.2
Rader, D.3
Packard, C.4
Feuerstein, G.5
-
8
-
-
0001184879
-
Note for guidance on general considerations for clinical trials
-
US Food and Drug Administration
-
US Food and Drug Administration. Note for guidance on general considerations for clinical trials. Fed. Regist. 62(242), 66113-66119 (1997).
-
(1997)
Fed. Regist.
, vol.62
, Issue.242
, pp. 66113-66119
-
-
-
9
-
-
78049471529
-
Lost roots. How project management settled on the phased approach (and compromised its ability to lead change in modern enterprises)
-
website [online]
-
Lenfle, S. & Loch, C. Lost roots. How project management settled on the phased approach (and compromised its ability to lead change in modern enterprises). Ecole Polytechnique website [online], http://crg.polytechnique.fr/ fichiers/crg/publications/ pdf/2010-03-06-1630.pdf (2009).
-
(2009)
Ecole Polytechnique
-
-
Lenfle, S.1
Loch, C.2
-
10
-
-
34547321424
-
-
John Wiley & Sons, Hoboken, New Jersey
-
Loch, C., DeMeyer, A. & Pich, M. Managing the unknown. A new approach to managing high uncertainty and risk in projects. (John Wiley & Sons, Hoboken, New Jersey, 2006).
-
(2006)
Managing the Unknown. A New Approach to Managing High Uncertainty and Risk in Projects
-
-
Loch, C.1
Demeyer, A.2
Pich, M.3
-
11
-
-
34948861224
-
Commercializing clinical trials-risks and benefits of the CRO boom
-
Shuchman, M. Commercializing clinical trials-risks and benefits of the CRO boom. N. Engl. J. Med. 357, 1365-1368 (2007).
-
(2007)
N. Engl. J. Med.
, vol.357
, pp. 1365-1368
-
-
Shuchman, M.1
-
12
-
-
19744380776
-
Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial
-
Bresalier, R. S. et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N. Engl. J. Med. 352, 1092-1102 (2005).
-
(2005)
N. Engl. J. Med.
, vol.352
, pp. 1092-1102
-
-
Bresalier, R.S.1
-
13
-
-
43949101389
-
Rebuilding the R & D engine in big pharma
-
72-76, 128
-
Garnier, J. P. Rebuilding the R&D engine in big pharma. Harv. Bus Rev. 86, 68-70, 72-76, 128 (2008).
-
(2008)
Harv. Bus Rev.
, vol.86
, pp. 68-70
-
-
Garnier, J.P.1
-
14
-
-
33750579770
-
Drug discovery in jeopardy
-
Cuatrecasas, P. Drug discovery in jeopardy. J. Clin. Invest. 11 6 , 2837-2842 (2006).
-
(2006)
J. Clin. Invest.
, vol.116
, pp. 2837-2842
-
-
Cuatrecasas, P.1
-
15
-
-
73449101512
-
Lessons from 60 years of pharmaceutical innovation
-
Munos, B. Lessons from 60 years of pharmaceutical innovation. Nature R e v. Drug Discov. 8, 959-968 (2009).
-
(2009)
Nature Rev. Drug Discov.
, vol.8
, pp. 959-968
-
-
Munos, B.1
-
17
-
-
78049467595
-
Challenge and opportunity on the critical path to new medical products
-
online
-
US Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. FDA website [online], http://www.fda.gov/ downloads/Drugs/ScienceResearch/ResearchAreas/ ucm079290.pdf (2004).
-
(2004)
FDA Website
-
-
-
18
-
-
0037912508
-
Concurrent engineering and design oscillations in complex engineering projects
-
Loch, C., Mihm, J. & Huchzermeier, A. Concurrent engineering and design oscillations in complex engineering projects. Concurrent Eng. 11 , 187-199 (2003).
-
(2003)
Concurrent Eng.
, vol.11
, pp. 187-199
-
-
Loch, C.1
Mihm, J.2
Huchzermeier, A.3
-
19
-
-
0000877699
-
Technology transfer as a function of position in the spectrum from research through development to technical services
-
Allen, T., Thusman, M. & Lee, D. Technology transfer as a function of position in the spectrum from research through development to technical services. Acad. Manage. J. 22, 694-708 (1979).
-
(1979)
Acad. Manage. J.
, vol.22
, pp. 694-708
-
-
Allen, T.1
Thusman, M.2
Lee, D.3
-
20
-
-
0003465502
-
-
1st edn Harvard Bus School Press, Boston, Massachusetts, USA
-
Roussel P. A., Saad, K. N. & Erickson, T. J. Third generation R&D: Managing the Link to Corporate Strategy 1st edn (Harvard Bus School Press, Boston, Massachusetts, USA, 1991).
-
(1991)
Third Generation R&D: Managing the Link to Corporate Strategy
-
-
Roussel, P.A.1
Saad, K.N.2
Erickson, T.J.3
-
21
-
-
0031003468
-
Learning versus confirming in clinical drug development
-
Sheiner, L. B. Learning versus confirming in clinical drug development. Clin. Pharmacol. Ther. 61, 275-291 (1997).
-
(1997)
Clin. Pharmacol. Ther.
, vol.61
, pp. 275-291
-
-
Sheiner, L.B.1
-
22
-
-
24044497597
-
Mechanism-based pharmacokinetic-pharmacodynamic modeling - A new classification of biomarkers
-
Danhof, M., Alvan, G., Dahl, S. G., Kuhlmann, J. & Paintaud, G. Mechanism-based pharmacokinetic-pharmacodynamic modeling-a new classification of biomarkers. Pharm. Res. 22, 1432-1437 (2005).
-
(2005)
Pharm. Res.
, vol.22
, pp. 1432-1437
-
-
Danhof, M.1
Alvan, G.2
Dahl, S.G.3
Kuhlmann, J.4
Paintaud, G.5
-
23
-
-
78049459495
-
Exploratory I.N.D. Studies
-
FDA Center for Drug Evaluation and Research online
-
FDA Center for Drug Evaluation and Research. Exploratory I.N.D. Studies. FDA website [online], http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/ucm078933.pdf (2006).
-
(2006)
FDA Website
-
-
-
24
-
-
33749648484
-
Establishing risk of human experimentation with drugs: Lessons from TGN1412
-
Kenter, M. J. & Cohen, A. F. Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet 368, 1387-1391 (2006).
-
(2006)
Lancet
, vol.368
, pp. 1387-1391
-
-
Kenter, M.J.1
Cohen, A.F.2
-
25
-
-
43649102392
-
Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: Designing informative human pharmacology studies
-
Cohen, A. Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: designing informative human pharmacology studies. Clin. Pharmacokinet. 47, 373-381 (2008).
-
(2008)
Clin. Pharmacokinet.
, vol.47
, pp. 373-381
-
-
Cohen, A.1
-
26
-
-
78049473850
-
Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Guidance for Industry
-
FDA Center for Drug Evaluation and Research online
-
FDA Center for Drug Evaluation and Research. Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Guidance for Industry. FDA website [online], http://www.fda.gov/do= wnloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/ucm078932.pdf (2005).
-
(2005)
FDA Website
-
-
-
27
-
-
34548038122
-
Should we tolerate tolerability as an objective in early drug development?
-
Cohen, A. Should we tolerate tolerability as an objective in early drug development? Br. J. Clin. Pharmacol. 64, 249-252 (2007).
-
(2007)
Br. J. Clin. Pharmacol.
, vol.64
, pp. 249-252
-
-
Cohen, A.1
-
28
-
-
0014709310
-
The evaluation of anticancer drugs in dogs and monkeys for the prediction of qualitative toxicities in man
-
Schein, P. S. et al. The evaluation of anticancer drugs in dogs and monkeys for the prediction of qualitative toxicities in man. Clin. Pharmacol. Ther. 11 , 3-40 (1970).
-
(1970)
Clin. Pharmacol. Ther.
, vol.11
, pp. 3-40
-
-
Schein, P.S.1
-
29
-
-
0013909023
-
Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey and man
-
Freireich, E. J., Gehan, E. A., Rall, D. P. , Schmidt, L. H. & Skipper, H. E. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey and man. Cancer Chemother. Rep. 50, 219-244 (1966).
-
(1966)
Cancer Chemother. Rep.
, vol.50
, pp. 219-244
-
-
Freireich, E.J.1
Gehan, E.A.2
Rall, D.P.3
Schmidt, L.H.4
Skipper, H.E.5
-
30
-
-
0033345899
-
Effect of meal timing not critical for the pharmacokinetics of tegaserod (HTF 919)
-
Zhou, H. et al. Effect of meal timing not critical for the pharmacokinetics of tegaserod (HTF 919). J. Clin. Pharmacol. 39, 911-919 (1999).
-
(1999)
J. Clin. Pharmacol.
, vol.39
, pp. 911-919
-
-
Zhou, H.1
-
31
-
-
0030893442
-
First pharmacokinetic-pharmacodynamic study in humans with a selective 5-hydroxytryptamine4 receptor agonist
-
Appel, S., Kumle, A., Hubert, M. & Duvauchelle, T. First pharmacokinetic-pharmacodynamic study in humans with a selective 5-hydroxytryptamine4 receptor agonist. J. Clin. Pharmacol. 37, 229-237 (1997).
-
(1997)
J. Clin. Pharmacol.
, vol.37
, pp. 229-237
-
-
Appel, S.1
Kumle, A.2
Hubert, M.3
Duvauchelle, T.4
-
32
-
-
69749097048
-
Functional characterization of contractions to tegaserod in human isolated proximal and distal coronary arteries
-
Chan K. Y. et al. Functional characterization of contractions to tegaserod in human isolated proximal and distal coronary arteries. Eur. J. Pharmacol. 619, 61-67 (2009).
-
(2009)
Eur. J. Pharmacol.
, vol.619
, pp. 61-67
-
-
Chan, K.Y.1
-
33
-
-
33751548315
-
The strange case of TGN1412
-
Farzaneh, L., Kasahara, N. & Farzaneh, F. The strange case of TGN1412. Cancer Immunol. Immunother. 56, 129-134 (2007).
-
(2007)
Cancer Immunol. Immunother.
, vol.56
, pp. 129-134
-
-
Farzaneh, L.1
Kasahara, N.2
Farzaneh, F.3
-
34
-
-
33745604934
-
(-/-) mice
-
(-/-) mice. Blood 108, 238-245 (2006).
-
(2006)
Blood
, vol.108
, pp. 238-245
-
-
Legrand, N.1
-
35
-
-
0003632158
-
-
Expert Scientific Group on Phase One clinical Trials The Stationary Office, Norwich, UK
-
Expert Scientific Group on Phase One clinical Trials. Final Report (The Stationary Office, Norwich, UK, 2006 ).
-
(2006)
Final Report
-
-
-
36
-
-
0036799756
-
Concentration-effect relationships of two rilmenidine single-dose infusion rates in hypertensive patients
-
De Visser, S. J. et al. Concentration-effect relationships of two rilmenidine single-dose infusion rates in hypertensive patients. Clin. Pharmacol. Ther. 72, 419-428 (2002).
-
(2002)
Clin. Pharmacol. Ther.
, vol.72
, pp. 419-428
-
-
De Visser, S.J.1
-
37
-
-
3242717667
-
Pharmacokinetic/ pharmacodynamic assessment of tolerance to central nervous system effects of a 3 mg sustained release tablet of rilmenidine in hypertensive patients
-
Van Der Post, J. P., de Visser, S. J., Schoemaker, R. C., Cohen, A. F. & van Gerven, J. M. Pharmacokinetic/ pharmacodynamic assessment of tolerance to central nervous system effects of a 3 mg sustained release tablet of rilmenidine in hypertensive patients. J. Psychopharmacol. 18, 221-227 (2004).
-
(2004)
J. Psychopharmacol.
, vol.18
, pp. 221-227
-
-
Van Der Post, J.P.1
De Visser, S.J.2
Schoemaker, R.C.3
Cohen, A.F.4
Van Gerven, J.M.5
-
38
-
-
0037238673
-
Biomarkers for the effects of benzodiazepines in healthy volunteers
-
De Visser, S. J. et al. Biomarkers for the effects of benzodiazepines in healthy volunteers. Br. J. Clin. Pharmacol. 55, 39-50 (2003).
-
(2003)
Br. J. Clin. Pharmacol.
, vol.55
, pp. 39-50
-
-
De Visser, S.J.1
-
39
-
-
33846979755
-
Promotion of sleep by targeting the orexin system in rats, dogs and humans
-
Brisbare-Roch, C. et al. Promotion of sleep by targeting the orexin system in rats, dogs and humans. Nature Med. 13, 150-155 (2007).
-
(2007)
Nature Med.
, vol.13
, pp. 150-155
-
-
Brisbare-Roch, C.1
-
41
-
-
0345257262
-
Joining the DoTS: New approach to classifying adverse drug reactions
-
Aronson, J. K. & Ferner, R. E. Joining the DoTS: new approach to classifying adverse drug reactions. BMJ 327, 1222-1225 (2003).
-
(2003)
BMJ
, vol.327
, pp. 1222-1225
-
-
Aronson, J.K.1
Ferner, R.E.2
-
43
-
-
62249197877
-
-
McGraw Hill Medical, USA
-
Brunton, L., Blumenthal, D., Buxton, I. & Parker, K. Goodman and Gilman's Manual of Pharmacology and Therapeutics (McGraw Hill Medical, USA, 2006).
-
(2006)
Goodman and Gilman's Manual of Pharmacology and Therapeutics
-
-
Brunton, L.1
Blumenthal, D.2
Buxton, I.3
Parker, K.4
-
44
-
-
38349179899
-
Clinical pharmacology in the molecular era
-
Dollery, C. T. Clinical pharmacology in the molecular era. Clin. Pharmacol. Ther. 83, 220-225 (2008).
-
(2008)
Clin. Pharmacol. Ther.
, vol.83
, pp. 220-225
-
-
Dollery, C.T.1
-
45
-
-
78049475682
-
An account of the foxglove and its medical uses, 1785-1985
-
Oxford Univ. Pres, London 1985
-
Aronson, J. An account of the foxglove and its medical uses, 1785-1985. (Oxford Univ. Pres, London 1985). Clin. Pharmacol. Ther. 83, 220-225 (2008).
-
(2008)
Clin. Pharmacol. Ther.
, vol.83
, pp. 220-225
-
-
Aronson, J.1
-
46
-
-
9844226779
-
Integrated pharmacokinetics and pharmacodynamics of Ro 48-8684, a new benzodiazepine, in comparison with midazolam during first administration to healthy male subjects
-
Van Gerven, J. M. et al. Integrated pharmacokinetics and pharmacodynamics of Ro 48-8684, a new benzodiazepine, in comparison with midazolam during first administration to healthy male subjects. Br. J. Clin. Pharmacol. 44, 487-493 (1997).
-
(1997)
Br. J. Clin. Pharmacol.
, vol.44
, pp. 487-493
-
-
Van Gerven, J.M.1
|