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1.
An Innovative Pharmacometric Approach for the Simultaneous Analysis of Frequency, Duration and Severity of Migraine Events.
Pharm Res
; 37(10): 189, 2020 Sep 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-32895855
2.
Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.
Mol Pharm
; 14(12): 4334-4338, 2017 12 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-29076742
3.
Exposure-response analyses of blood pressure and heart rate changes for methylphenidate in healthy adults.
J Pharmacokinet Pharmacodyn
; 44(3): 245-262, 2017 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-28214989
4.
Pediatric Extrapolation Approach for U.S. Food and Drug Administration Approval of Brexpiprazole in Patients Aged 13 to 17 Years with Schizophrenia.
J Clin Pharmacol
; 2024 Mar 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-38488344
5.
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
6.
Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective.
Clin Pharmacol Ther
; 112(4): 853-863, 2022 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-35678047
7.
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
8.
Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder.
J Clin Pharmacol
; 61 Suppl 1: S117-S124, 2021 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-34185904
9.
Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective.
Clin Pharmacol Ther
; 110(4): 880-887, 2021 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-33492710
10.
The Trend of Increasing Placebo Response and Decreasing Treatment Effect in Schizophrenia Trials Continues: An Update From the US Food and Drug Administration.
J Clin Psychiatry
; 81(2)2020 03 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-32141721
11.
Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.
JAMA Psychiatry
; 77(10): 1064-1071, 2020 10 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-32609294
12.
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
13.
Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia.
J Clin Pharmacol
; 60(7): 848-859, 2020 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-31994186
14.
Pharmacometric Bridging Approach for U.S. Food and Drug Administration Approval and Identification of Topiramate Dosing Regimen for Pediatric Patients 2-9 Years of Age With Epilepsy.
J Pharm Sci
; 108(4): 1598-1603, 2019 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-30468826
15.
A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.
Clin Transl Sci
; 12(6): 564-572, 2019 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-31169344
16.
A Quantitative Justification of Similarity in Placebo Response Between Adults and Adolescents With Acute Exacerbation of Schizophrenia in Clinical Trials.
Clin Pharmacol Ther
; 106(5): 1046-1055, 2019 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-31069784
17.
An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs.
J Clin Pharmacol
; 53(10): 1005-9, 2013 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-23842865
18.
Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities.
J Pharm Sci
; 93(6): 1375-81, 2004 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-15124197
19.
Improving pediatric dosing through pediatric initiatives: what we have learned.
Pediatrics
; 121(3): 530-9, 2008 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-18310202
20.
Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations.
AAPS J
; 14(4): 925-6, 2012 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-22976173