Detalhe da pesquisa
1.
Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making.
Pharm Res
; 39(8): 1669-1680, 2022 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-35552984
2.
Heterogeneity in treatment effects across diverse populations.
Pharm Stat
; 20(5): 929-938, 2021 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-34396690
3.
Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.
Circulation
; 132(15): 1425-32, 2015 Oct 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-26459078
4.
Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study.
J Pharmacokinet Pharmacodyn
; 41(6): 693-704, 2014 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-25326066
5.
Statin Drug-Drug Interactions: Pharmacokinetic Basis of FDA Labeling Recommendations and Comparison Across Common Tertiary Clinical Resources.
J Clin Pharmacol
; 64(6): 704-712, 2024 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-38299698
6.
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins.
Clin Pharmacol Ther
; 115(3): 440-451, 2024 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-38235832
7.
Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities.
J Clin Pharmacol
; 63 Suppl 2: S10-S17, 2023 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-37942907
8.
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives.
Clin Pharmacol Ther
; 113(3): 528-535, 2023 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-36514867
9.
US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information.
J Clin Pharmacol
; 63(6): 695-703, 2023 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-36731882
10.
Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation.
AAPS J
; 25(3): 33, 2023 03 29.
Artigo
em Inglês
| MEDLINE | ID: mdl-36991196
11.
Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020.
Clin Transl Sci
; 16(10): 2046-2057, 2023 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-37551830
12.
Need for Representation of Pediatric Patients with Obesity in Clinical Trials.
Children (Basel)
; 10(10)2023 Sep 30.
Artigo
em Inglês
| MEDLINE | ID: mdl-37892303
13.
Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol.
J Clin Pharmacol
; 63 Suppl 1: S106-S116, 2023 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-37317500
14.
Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice: a clinical trial simulation case study.
J Pharmacokinet Pharmacodyn
; 39(3): 283-94, 2012 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-22569889
15.
Current Perspective on Residual Knowledge Gaps in the Assessment of Transporter-Mediated Drug Interactions.
Clin Pharmacol Ther
; 112(3): 450-452, 2022 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-35722741
16.
Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non-orphan drugs approved by the FDA.
Clin Transl Sci
; 15(11): 2583-2596, 2022 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-36165094
17.
Roadmap to 2030 for Drug Evaluation in Older Adults.
Clin Pharmacol Ther
; 112(2): 210-223, 2022 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-34656074
18.
Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.
Clin Pharmacol Ther
; 109(3): 697-704, 2021 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-32895941
19.
A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration.
Clin Pharmacol Ther
; 109(1): 123-130, 2021 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-33022770
20.
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.
CPT Pharmacometrics Syst Pharmacol
; 10(12): 1479-1484, 2021 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-34734497