Detalles de la búsqueda
1.
Assessing and mitigating pH-mediated DDI risks in drug development - formulation approaches and clinical considerations.
Drug Metab Rev
; : 1-20, 2024 May 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-38700278
2.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-38600804
3.
Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs.
Pharm Res
; 40(2): 337-357, 2023 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-35840856
4.
Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium "Long-Acting Injectables" Working Group.
Pharm Res
; 40(7): 1601-1631, 2023 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-36811809
5.
Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective.
Pharm Res
; 39(8): 1701-1731, 2022 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-35552967
6.
Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives.
Pharm Res
; 37(6): 95, 2020 May 13.
Artículo
en Inglés
| MEDLINE | ID: mdl-32405699
7.
Verification of a physiologically based pharmacokinetic model of ritonavir to estimate drug-drug interaction potential of CYP3A4 substrates.
Biopharm Drug Dispos
; 39(3): 152-163, 2018 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-29451681
8.
Midostaurin, a Novel Protein Kinase Inhibitor for the Treatment of Acute Myelogenous Leukemia: Insights from Human Absorption, Metabolism, and Excretion Studies of a BDDCS II Drug.
Drug Metab Dispos
; 45(5): 540-555, 2017 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-28270565
9.
Integrated TK-TD modeling for drug-induced concurrent tachycardia and QT changes in beagle dogs.
J Pharmacokinet Pharmacodyn
; 44(5): 449-462, 2017 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-28643108
10.
Antiviral Nucleotide Incorporation by Recombinant Human Mitochondrial RNA Polymerase Is Predictive of Increased In Vivo Mitochondrial Toxicity Risk.
Antimicrob Agents Chemother
; 60(12): 7077-7085, 2016 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-27645237
11.
Novel orally swallowable IntelliCap(®) device to quantify regional drug absorption in human GI tract using diltiazem as model drug.
AAPS PharmSciTech
; 15(6): 1490-7, 2014 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-25023947
12.
Application of physiologically based absorption modeling to formulation development of a low solubility, low permeability weak base: mechanistic investigation of food effect.
AAPS PharmSciTech
; 15(2): 400-6, 2014 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-24435225
13.
Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space.
AAPS J
; 26(4): 69, 2024 Jun 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-38862807
14.
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products.
AAPS J
; 26(1): 19, 2024 01 24.
Artículo
en Inglés
| MEDLINE | ID: mdl-38267737
15.
Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound.
AAPS PharmSciTech
; 14(3): 1255-66, 2013 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-23955148
16.
Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary.
AAPS J
; 25(6): 96, 2023 10 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-37783902
17.
Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039.
AAPS J
; 25(1): 25, 2023 02 14.
Artículo
en Inglés
| MEDLINE | ID: mdl-36788163
18.
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial of Radiopaque Islatravir-Eluting Subdermal Implants for Pre-exposure Prophylaxis Against HIV-1 Infection.
J Acquir Immune Defic Syndr
; 92(4): 310-316, 2023 04 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-36450129
19.
Dissolution Profile Similarity Assessment-Best Practices, Decision Trees and Global Harmonization.
AAPS J
; 25(3): 44, 2023 04 21.
Artículo
en Inglés
| MEDLINE | ID: mdl-37084114
20.
Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
CPT Pharmacometrics Syst Pharmacol
; 12(5): 585-597, 2023 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-36530026