-
1
-
-
34648850101
-
-
published online April
-
Elias, T., Gordian, M., Singh, N. & Zemmel, R. Why Products Fail in Phase III. IN VIVO, published online April 2006.
-
(2006)
Why Products Fail in Phase III in VIVO
-
-
Elias, T.1
Gordian, M.2
Singh, N.3
Zemmel, R.4
-
2
-
-
33645675960
-
Estimating the cost of new drug development: Is it really 802 million dollars?
-
Adams, C.P. & Branter, V.V. Estimating the cost of new drug development: is it really 802 million dollars? Health Affairs 25, 420-428 (2006).
-
(2006)
Health Affairs
, vol.25
, pp. 420-428
-
-
Adams, C.P.1
Branter, V.V.2
-
3
-
-
33646649531
-
Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications
-
Bhattaram, V.A. et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J. 7, E503-E512 (2005).
-
(2005)
AAPS J.
, vol.7
-
-
Bhattaram, V.A.1
-
4
-
-
33846573411
-
Impact of pharmacometric reviews on new drug approval and labeling decisions\a survey of 31 new drug applications submitted between 2005 and 2006
-
Bhattaram, V.A. et al. Impact of pharmacometric reviews on new drug approval and labeling decisions\a survey of 31 new drug applications submitted between 2005 and 2006. Clin. Pharmacol. Ther. 81, 213-221 (2007).
-
(2007)
Clin. Pharmacol. Ther.
, vol.81
, pp. 213-221
-
-
Bhattaram, V.A.1
-
5
-
-
34250749661
-
Model-based drug development
-
Lalonde, R.L. et al. Model-based drug development. Clin. Pharmacol. Ther. 82, 21-32 (2007).
-
(2007)
Clin. Pharmacol. Ther.
, vol.82
, pp. 21-32
-
-
Lalonde, R.L.1
-
6
-
-
33745779940
-
Model-based drug development: The road to quantitative pharmacology
-
Zhang, L. et al. Model-based drug development: the road to quantitative pharmacology. J. Pharmacokinet. Pharmacodyn. 33, 369-393 (2006).
-
(2006)
J. Pharmacokinet. Pharmacodyn.
, vol.33
, pp. 369-393
-
-
Zhang, L.1
-
7
-
-
38349115335
-
Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006
-
Wang, Y. et al. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. J. Clin. Pharmacol. 48, 146-156 (2008).
-
(2008)
J. Clin. Pharmacol.
, vol.48
, pp. 146-156
-
-
Wang, Y.1
-
8
-
-
0034065083
-
Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process: Experience at Parke-Davis
-
Olson, S.C. et al. Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process: experience at Parke-Davis. Clin. Pharmacokinet. 38, 449-459 (2000).
-
(2000)
Clin. Pharmacokinet.
, vol.38
, pp. 449-459
-
-
Olson, S.C.1
-
9
-
-
0030849120
-
An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann la Roche
-
Reigner, B.G., Williams, P.E., Patel, I.H., Steimer, J.L., Peck, C. & van Brummelen, P. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche. Clin. Pharmacokinet. 33, 142-152 (1997).
-
(1997)
Clin. Pharmacokinet.
, vol.33
, pp. 142-152
-
-
Reigner, B.G.1
Williams, P.E.2
Patel, I.H.3
Steimer, J.L.4
Peck, C.5
Van Brummelen, P.6
-
10
-
-
0003556719
-
-
US Food and Drug Administration. Center for Drug Evaluation and Research Center for Biologics Evaluation and Research February 1999
-
US Food and Drug Administration. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry: Population Pharmacokinetics (February 1999).
-
Guidance for Industry: Population Pharmacokinetics
-
-
-
15
-
-
33846600867
-
Paving the critical path: How can clinical pharmacology help achieve the vision?
-
Lesko, L.J. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin. Pharmacol. Ther. 81, 170-177 (2007).
-
(2007)
Clin. Pharmacol. Ther.
, vol.81
, pp. 170-177
-
-
Lesko, L.J.1
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