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1.
Achieving big with small: quantitative clinical pharmacology tools for drug development in pediatric rare diseases.
J Pharmacokinet Pharmacodyn
; 50(6): 429-444, 2023 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-37140724
2.
An integrated PK-PD model for cortisol and the 17-hydroxyprogesterone and androstenedione biomarkers in children with congenital adrenal hyperplasia.
Br J Clin Pharmacol
; 87(3): 1098-1110, 2021 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-32652643
3.
Orphan drug development: the increasing role of clinical pharmacology.
J Pharmacokinet Pharmacodyn
; 46(5): 395-409, 2019 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-31338634
4.
Amikacin Pharmacokinetic-Pharmacodynamic Analysis in Pediatric Cancer Patients.
Antimicrob Agents Chemother
; 62(4)2018 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-29358293
5.
A model-based approach to assess the exposure-response relationship of Lorenzo's oil in adrenoleukodystrophy.
Br J Clin Pharmacol
; 81(6): 1058-66, 2016 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-26836218
6.
A hierarchical Bayesian approach for combining pharmacokinetic/pharmacodynamic modeling and Phase IIa trial design in orphan drugs: Treating adrenoleukodystrophy with Lorenzo's oil.
J Biopharm Stat
; 26(6): 1025-1039, 2016.
Artículo
en Inglés
| MEDLINE | ID: mdl-27547896
7.
Lanadelumab in Patients 2 to Less Than 12 Years Old With Hereditary Angioedema: Results From the Phase 3 SPRING Study.
J Allergy Clin Immunol Pract
; 12(1): 201-211.e6, 2024 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-37730089
8.
Covariate modeling in pharmacometrics: General points for consideration.
CPT Pharmacometrics Syst Pharmacol
; 13(5): 710-728, 2024 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-38566433
9.
Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper.
Clin Pharmacol Ther
; 114(3): 515-529, 2023 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-37313953
10.
Clinical Pharmacology in Drug Development for Rare Diseases in Neurology: Contributions and Opportunities.
Clin Pharmacol Ther
; 111(4): 786-798, 2022 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-34860361
11.
Concordance of Exposure Changes Because of Renal Impairment Between Results of Dedicated Renal Impairment Studies and Population Pharmacokinetic Predictions.
J Clin Pharmacol
; 61(10): 1324-1333, 2021 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-33997992
12.
Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development.
Clin Transl Sci
; 13(1): 31-40, 2020 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-31674150
13.
Application of Clinical Pharmacology Principles in Drug Development of Modified-Release Products: Leveraging Exposure-Response Information to Support Approval.
J Clin Pharmacol
; 60(11): 1441-1452, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-32453882
14.
Mycophenolic Acid and Its Metabolites in Kidney Transplant Recipients: A Semimechanistic Enterohepatic Circulation Model to Improve Estimating Exposure.
J Clin Pharmacol
; 58(5): 628-639, 2018 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-29329489
15.
Stable Isotope Pharmacokinetic Studies Provide Insight into Effects of Age, Sex, and Weight on Levothyroxine Metabolism.
Thyroid
; 28(1): 41-49, 2018 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29212434
16.
Think Rare, Think Inside and Out: Simple Question-Based Approach to Complex Rare Disease Drug Development.
J Clin Pharmacol
; 62 Suppl 2: S6-S11, 2022 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-36461741
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