Detalhe da pesquisa
1.
AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer.
N Engl J Med
; 372(18): 1689-99, 2015 Apr 30.
Artigo
Inglês
| MEDLINE | ID: mdl-25923549
2.
Effect of multiple-dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin.
Br J Clin Pharmacol
; 84(12): 2877-2888, 2018 12.
Artigo
Inglês
| MEDLINE | ID: mdl-30171779
3.
The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib.
Br J Clin Pharmacol
; 84(6): 1156-1169, 2018 06.
Artigo
Inglês
| MEDLINE | ID: mdl-29381826
4.
Metabolic Disposition of Osimertinib in Rats, Dogs, and Humans: Insights into a Drug Designed to Bind Covalently to a Cysteine Residue of Epidermal Growth Factor Receptor.
Drug Metab Dispos
; 44(8): 1201-12, 2016 08.
Artigo
Inglês
| MEDLINE | ID: mdl-27226351
5.
Determining bioequivalence possibilities of long acting injectables through population PK modelling.
Eur J Pharm Sci
; 179: 106296, 2022 Dec 01.
Artigo
Inglês
| MEDLINE | ID: mdl-36184958
6.
Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series.
Pharmaceutics
; 14(5)2022 May 07.
Artigo
Inglês
| MEDLINE | ID: mdl-35631595
7.
Exploring a model-based analysis of patient derived xenograft studies in oncology drug development.
PeerJ
; 9: e10681, 2021.
Artigo
Inglês
| MEDLINE | ID: mdl-33569251
8.
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
Inglês
| MEDLINE | ID: mdl-33152375
9.
Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.
AAPS J
; 22(5): 97, 2020 07 27.
Artigo
Inglês
| MEDLINE | ID: mdl-32719954
10.
Correction to: Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.
AAPS J
; 23(1): 7, 2020 Dec 03.
Artigo
Inglês
| MEDLINE | ID: mdl-33270171
11.
The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non-Small-Cell Lung Cancer and in Healthy Volunteers.
J Clin Pharmacol
; 58(4): 474-484, 2018 04.
Artigo
Inglês
| MEDLINE | ID: mdl-29178442
12.
The effects of pharmaceutical excipients on drug disposition.
Adv Drug Deliv Rev
; 59(15): 1482-503, 2007 Dec 22.
Artigo
Inglês
| MEDLINE | ID: mdl-18198495
13.
Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid.
J Pharm Sci
; 105(11): 3243-3255, 2016 11.
Artigo
Inglês
| MEDLINE | ID: mdl-27659159
14.
Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies.
Cancer Chemother Pharmacol
; 77(4): 767-76, 2016 Apr.
Artigo
Inglês
| MEDLINE | ID: mdl-26902828
15.
The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.
J Pharm Sci
; 103(11): 3377-3397, 2014 Nov.
Artigo
Inglês
| MEDLINE | ID: mdl-25256402
16.
In vitro models for the prediction of in vivo performance of oral dosage forms.
Eur J Pharm Sci
; 57: 342-66, 2014 Jun 16.
Artigo
Inglês
| MEDLINE | ID: mdl-23988843
17.
Oral bioavailability of cinnarizine in dogs: relation to SNEDDS droplet size, drug solubility and in vitro precipitation.
Eur J Pharm Sci
; 48(1-2): 339-50, 2013 Jan 23.
Artigo
Inglês
| MEDLINE | ID: mdl-23178440
18.
An investigation into the utility of a multi-compartmental, dynamic, system of the upper gastrointestinal tract to support formulation development and establish bioequivalence of poorly soluble drugs.
AAPS J
; 14(2): 196-205, 2012 Jun.
Artigo
Inglês
| MEDLINE | ID: mdl-22374384
19.
Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.
AAPS J
; 14(3): 627-38, 2012 Sep.
Artigo
Inglês
| MEDLINE | ID: mdl-22684402
20.
Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit.
AAPS J
; 12(3): 465-72, 2010 Sep.
Artigo
Inglês
| MEDLINE | ID: mdl-20517660