Detalhe da pesquisa
1.
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Mol Pharm
; 21(5): 2065-2080, 2024 May 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-38600804
2.
Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives.
Pharm Res
; 37(6): 95, 2020 May 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-32405699
3.
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling.
AAPS J
; 26(3): 54, 2024 04 24.
Artigo
em Inglês
| MEDLINE | ID: mdl-38658473
4.
Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure.
Clin Pharmacol Drug Dev
; 13(4): 440-448, 2024 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-38396317
5.
Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling.
J Pharm Sci
; 111(1): 262-273, 2022 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-34678271
6.
DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.
AAPS J
; 24(3): 54, 2022 04 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-35386051
7.
Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.
J Pharm Sci
; 110(2): 555-566, 2021 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-32380182
8.
Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies.
J Pharm Sci
; 110(12): 3896-3906, 2021 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-34551349
9.
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.
Clin Pharmacol Ther
; 110(5): 1190-1195, 2021 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-33236362
10.
In Vitro Biopredictive Methods: A Workshop Summary Report.
J Pharm Sci
; 110(2): 567-583, 2021 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-32956678
11.
Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.
J Pharm Sci
; 110(2): 584-593, 2021 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-33058891
12.
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
J Pharm Sci
; 110(2): 594-609, 2021 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-33152375
13.
In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop Summary Report.
AAPS J
; 22(4): 74, 2020 05 19.
Artigo
em Inglês
| MEDLINE | ID: mdl-32430592
14.
Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.
AAPS J
; 21(2): 29, 2019 02 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-30746576
15.
Dissolution Testing in Drug Product Development: Workshop Summary Report.
AAPS J
; 21(2): 21, 2019 01 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-30690680
16.
Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report.
AAPS J
; 20(3): 60, 2018 04 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-29633092
17.
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
AAPS J
; 20(6): 93, 2018 08 27.
Artigo
em Inglês
| MEDLINE | ID: mdl-30151612
18.
Application of an NLME-Stochastic Deconvolution Approach to Level A IVIVC Modeling.
J Pharm Sci
; 106(7): 1905-1916, 2017 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-28341596
19.
Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications.
AAPS J
; 18(6): 1379-1390, 2016 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-27480319
20.
Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications.
AAPS J
; 18(3): 578-88, 2016 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-26928450