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1.
The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities.
J Pharm Pharm Sci;
27: 12398, 2024.
Artículo
en Inglés
| MEDLINE | ID: mdl-38577255
2.
A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme.
J Pharm Pharm Sci;
25: 323-339, 2022.
Artículo
en Inglés
| MEDLINE | ID: mdl-36251699
3.
Model-based simulation to support the extended dosing regimens of atezolizumab.
Eur J Clin Pharmacol;
77(1): 87-93, 2021 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-32808071
4.
A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme.
J Pharm Pharm Sci;
24: 113-126, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-33734975
5.
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.
J Pharm Pharm Sci;
24: 548-562, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-34706215
6.
Approval of modified-release products by FDA without clinical efficacy/safety studies: A retrospective survey from 2008 to 2017.
Regul Toxicol Pharmacol;
103: 174-180, 2019 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-30711621
7.
Investigation of the Discriminatory Ability of Pharmacokinetic Metrics for the Bioequivalence Assessment of PEGylated Liposomal Doxorubicin.
Pharm Res;
35(5): 106, 2018 Mar 21.
Artículo
en Inglés
| MEDLINE | ID: mdl-29564719
8.
Authors' reply to letters to the editor "model-based simulation to support the extended dosing regimens of atezolizumab".
Eur J Clin Pharmacol;
77(7): 1067-1068, 2021 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-33237384
9.
Pharmacokinetics of vancomycin in adults receiving extracorporeal membrane oxygenation.
J Formos Med Assoc;
115(7): 560-70, 2016 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-26123638
10.
A statistical analysis to assess the most critical bioequivalence parameters for generic liposomal products.
Int J Clin Pharmacol Ther;
52(12): 1071-82, 2014 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-25207546
11.
Evaluation of etanercept dose reduction in patients with rheumatoid arthritis using pharmacokinetic/pharmacodynamic modeling and simulation.
Int J Clin Pharmacol Ther;
52(9): 776-86, 2014 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-24887337
12.
The role of partial area under the curve and maximum concentrations in assessing the bioequivalence of long-acting injectable formulation of exenatide_A sensitivity analysis.
Eur J Pharm Sci;
195: 106718, 2024 Apr 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-38316168
13.
A Survey of Population Pharmacokinetic Reports Submitted to the USFDA: An Analysis of Common Issues in NDA and BLA from 2012 to 2021.
Clin Pharmacokinet;
61(12): 1697-1703, 2022 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-36316621
14.
Investigation of the discriminatory ability of analytes for the bioequivalence assessment of ezetimibe: Parent drug, metabolite, total form, and combination of parent drug and total form.
Eur J Pharm Sci;
174: 106192, 2022 Jul 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-35439544
15.
Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?
BioDrugs;
33(4): 437-446, 2019 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-31111423
16.
Evaluating the Feasibility of Use of a Foreign Reference Product for Generic Drug Applications: A Retrospective Pilot Study.
Eur J Drug Metab Pharmacokinet;
42(6): 935-942, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-28283987
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