Detalhe da pesquisa
1.
Interchangeability of generic drugs for subpopulations: Bioequivalence simulation from a nonparametric PK model of gabapentin generic drugs.
Br J Clin Pharmacol
; 2022 Dec 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-36482842
2.
Drug switching in the Netherlands: a cohort study of 20 active substances.
BMC Health Serv Res
; 20(1): 650, 2020 Jul 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-32660480
3.
A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials.
Br J Clin Pharmacol
; 81(4): 667-78, 2016 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-26574160
4.
Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines.
Eur J Clin Pharmacol
; 71(8): 979-90, 2015 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-26062932
5.
Reported hepatotoxicity and hepatotoxicity guidance in the product information of protein kinase inhibitors in oncology registered at the European Medicines Agency.
Pharmacol Res Perspect
; 11(2): e01067, 2023 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-36846954
6.
Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency.
Front Med (Lausanne)
; 9: 893028, 2022.
Artigo
em Inglês
| MEDLINE | ID: mdl-35602486
7.
Impact of the new European Union In Vitro Diagnostics Regulation on the practice of hospital diagnostic laboratories.
Expert Rev Mol Diagn
; 22(5): 583-590, 2022 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-35673983
8.
Interchangeability of generic anti-epileptic drugs: a quantitative analysis of topiramate and gabapentin.
Eur J Clin Pharmacol
; 67(10): 1007-16, 2011 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-21494766
9.
Pharmacogenetic-Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017.
Clin Pharmacol Ther
; 108(2): 338-349, 2020 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-32236952
10.
Pharmacokinetics and Generic Drug Switching: A Regulator's View.
Clin Pharmacokinet
; 59(9): 1065-1069, 2020 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-32557345
11.
Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands.
Clin Transl Sci
; 13(3): 599-607, 2020 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-32052597
12.
Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?
Pharmaceut Med
; 33(5): 407-416, 2019 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-31933229
13.
The mechanisms of pharmacokinetic food-drug interactions - A perspective from the UNGAP group.
Eur J Pharm Sci
; 134: 31-59, 2019 Jun 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-30974173
14.
Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs.
Clin Pharmacol Ther
; 104(5): 966-973, 2018 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-29330847
15.
Expression of the breast cancer resistance protein in breast cancer.
Clin Cancer Res
; 8(4): 1068-74, 2002 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-11948115
16.
Randomized phase I clinical and pharmacologic study of weekly versus twice-weekly dose-intensive cisplatin and gemcitabine in patients with advanced non-small cell lung cancer.
Clin Cancer Res
; 9(10 Pt 1): 3526-33, 2003 Sep 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-14506138
17.
Comment on "Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?"
Clin Pharmacokinet
; 59(2): 281-282, 2020 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-31802403
18.
Phase I and pharmacokinetic study of SPI-77, a liposomal encapsulated dosage form of cisplatin.
Cancer Chemother Pharmacol
; 49(3): 201-10, 2002 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-11935212
19.
Interchangeability of Generics-Experiences and Outlook Toward Pharmacokinetics Variability and Generic-Generic Substitution.
Clin Pharmacol Ther
; 105(2): 292-294, 2019 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-30460681
20.
Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective.
Nat Rev Drug Discov
; 12(2): 103-15, 2013 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-23370249