Detalles de la búsqueda
1.
Feasibility of Using Population Pharmacokinetics-Based Virtual Control Groups in Organ Impairment Studies.
J Clin Pharmacol
; 64(6): 713-718, 2024 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-38346862
2.
Evaluation of the Effects of Meal Type and Acid-Reducing Agents on the Pharmacokinetics of Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.
Clin Pharmacol Drug Dev
; 13(6): 677-687, 2024 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-38346861
3.
Pharmacokinetics and Safety of Firsocostat, an Acetyl-Coenzyme A Carboxylase Inhibitor, in Participants with Mild, Moderate, and Severe Hepatic Impairment.
J Clin Pharmacol
; 2024 Mar 22.
Artículo
en Inglés
| MEDLINE | ID: mdl-38520128
4.
Gender Affirming Hormones Do Not Affect the Exposure and Efficacy of F/TDF or F/TAF for HIV Preexposure Prophylaxis: A Subgroup Analysis from the DISCOVER Trial.
Transgend Health
; 9(1): 46-52, 2024 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-38312459
5.
An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia.
J Clin Psychopharmacol
; 33(2): 152-6, 2013 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-23422374
6.
Characterization of the US Food and Drug Administration Post-Marketing Commitments and Requirements for Pregnancy and Lactation.
Clin Pharmacol Ther
; 114(6): 1238-1242, 2023 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-37750407
7.
Design and conduct considerations for studies in patients with hepatic impairment.
Clin Transl Sci
; 16(1): 50-61, 2023 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-36176049
8.
Pharmacokinetics, pharmacodynamics, safety and tolerability of cilofexor, a novel nonsteroidal Farnesoid X receptor agonist, in healthy volunteers.
Clin Transl Sci
; 16(3): 536-547, 2023 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-36573450
9.
Effect of Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.
J Clin Pharmacol
; 63(9): 1017-1025, 2023 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-37128693
10.
Evaluation of the Potential for Cytochrome P450 and Transporter-Mediated Drug-Drug Interactions for Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor (FXR) Agonist.
Clin Pharmacokinet
; 62(4): 609-621, 2023 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-36906733
11.
Effect of Renal Impairment on the Pharmacokinetics of Firsocostat, an Acetyl-Coenzyme A Carboxylase Inhibitor, and Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.
J Clin Pharmacol
; 63(5): 560-568, 2023 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-36700458
12.
Clinical Pharmacology Applications of Real-World Data and Real-World Evidence in Drug Development and Approval-An Industry Perspective.
Clin Pharmacol Ther
; 114(4): 751-767, 2023 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-37393555
13.
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
14.
Glutathione conjugation of busulfan produces a hydroxyl radical-trapping dehydroalanine metabolite.
Xenobiotica
; 42(12): 1170-7, 2012 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-22725664
15.
Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases.
J Clin Pharmacol
; 62 Suppl 2: S72-S78, 2022 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-36461747
16.
Trends in FDA Transporter-Based Post-Marketing Requirements and Commitments Over the Last Decade.
Clin Pharmacol Ther
; 112(3): 635-642, 2022 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35780478
17.
Time to Rethink the Current Paradigm for Assessing Kidney Function in Drug Development and Beyond.
Clin Pharmacol Ther
; 112(5): 946-958, 2022 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-34800044
18.
Evaluation of US Food and Drug Administration Drug Label Recommendations for Coadministration of Antivirals and Acid-Reducing Agents.
Clin Pharmacol Ther
; 112(5): 1088-1097, 2022 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-35920069
19.
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
20.
Shortened Positive and Negative Symptom Scale as an Alternate Clinical Endpoint for Acute Schizophrenia Trials: Analysis from the US Food & Drug Administration.
Psychiatr Res Clin Pract
; 3(1): 38-45, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-36101554