-
1
-
-
33744961171
-
Highlights and a hidden hazard - The FDA's new labeling regulations
-
Avorn, J. & Shrank, W. Highlights and a hidden hazard - the FDA's new labeling regulations. N. Engl. J. Med. 354, 2409-2411 (2006).
-
(2006)
N. Engl. J. Med.
, vol.354
, pp. 2409-2411
-
-
Avorn, J.1
Shrank, W.2
-
3
-
-
84859931629
-
-
US Food and Drug Administration. Medical, statistical, and clinical pharmacology reviews of pediatric studies conducted under section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2007 (FDAAA). 〈http:// www.fda.gov/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/UCM049872〉 (2011).
-
(2011)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, As Amended by the FDA Amendments Act of 2007 (FDAAA)
-
-
-
4
-
-
33646417326
-
Off-label prescribing among office-based physicians
-
Radley, D., Finkelstein, S. & Stafford, R.S. Off-label prescribing among office-based physicians. Arch. Intern. Med. 166, 1021-1026 (2006).
-
(2006)
Arch. Intern. Med.
, vol.166
, pp. 1021-1026
-
-
Radley, D.1
Finkelstein, S.2
Stafford, R.S.3
-
5
-
-
84859976904
-
Off-label use of drugs and medical devices: A review of policy implications
-
Stafford, R.S. Off-label use of drugs and medical devices: a review of policy implications. Clin. Pharmacol. Ther. 91, 920-925 (2012)
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 920-925
-
-
Stafford, R.S.1
-
6
-
-
84859930662
-
Off-label drug use in pediatric patients
-
Kimland, E. & Odlind, V. Off-label drug use in pediatric patients. Clin. Pharmacol. Ther. 91, 796-801 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 796-801
-
-
Kimland, E.1
Odlind, V.2
-
7
-
-
84859981582
-
Monitoring the safety of medicines used off-label
-
Dal Pan, G.J. Monitoring the safety of medicines used off-label. Clin. Pharmacol. Ther. 91, 787-795 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 787-795
-
-
Dal Pan, G.J.1
-
8
-
-
84860002585
-
The use of observational health-care data to identify and report on off-label use of biopharmaceutical products
-
Morris, J. The use of observational health-care data to identify and report on off-label use of biopharmaceutical products. Clin. Pharmacol. Ther. 91, 937-942 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 937-942
-
-
Morris, J.1
-
9
-
-
84859994663
-
Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials
-
Leong, R. et al. Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials. Clin. Pharmacol. Ther. 91, 926-931 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 926-931
-
-
Leong, R.1
-
10
-
-
80155150400
-
Clinical pharmacology as a cornerstone of orphan drug development
-
Bashaw, E.D. et al. Clinical pharmacology as a cornerstone of orphan drug development. Nat. Rev. Drug Discov. 10, 795-796 (2011).
-
(2011)
Nat. Rev. Drug Discov.
, vol.10
, pp. 795-796
-
-
Bashaw, E.D.1
-
11
-
-
84859943689
-
Clinical pharmacology and orphan drugs: An informational inventory 2006-2010
-
Bashaw, E.D. & Fang, L. Clinical pharmacology and orphan drugs: an informational inventory 2006-2010. Clin. Pharmacol. Ther. 91, 932-936 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 932-936
-
-
Bashaw, E.D.1
Fang, L.2
-
12
-
-
84857237867
-
Adoption of pharmacogenomic testing by US physicians: Results of a nationwide survey
-
Stanek, E.J. et al. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin. Pharmacol. Ther. 91, 450-458 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 450-458
-
-
Stanek, E.J.1
-
13
-
-
84859965604
-
Influence of pharmacy benefit practices on off-label dispensing of drugs in the United States
-
Teagarden, J.R., Dreitlein, W.B., Kourlas, H. & Nichols, L. Influence of pharmacy benefit practices on off-label dispensing of drugs in the United States. Clin. Pharmacol. Ther. 91, 943-945 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 943-945
-
-
Teagarden, J.R.1
Dreitlein, W.B.2
Kourlas, H.3
Nichols, L.4
-
14
-
-
84859954049
-
Electronic health records: The new vehicle for drug labeling, safety, and efficacy
-
Fotsch, E.J. Electronic health records: the new vehicle for drug labeling, safety, and efficacy. Clin. Pharmacol. Ther. 91, 917-919 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 917-919
-
-
Fotsch, E.J.1
|