Detalhe da pesquisa
1.
Paediatric extrapolation: A necessary paradigm shift.
Br J Clin Pharmacol;
85(4): 675-679, 2019 04.
Artigo
em Inglês
| MEDLINE
| ID: mdl-30403304
2.
Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations.
Clin Infect Dis;
64(11): 1597-1603, 2017 Jun 01.
Artigo
em Inglês
| MEDLINE
| ID: mdl-29190337
3.
Fostering responsible research with genome editing technologies: a European perspective.
Transgenic Res;
26(5): 709-713, 2017 10.
Artigo
em Inglês
| MEDLINE
| ID: mdl-28730514
4.
Impact of the European paediatric legislation in paediatric rheumatology: past, present and future.
Ann Rheum Dis;
72(12): 1893-6, 2013 Dec.
Artigo
em Inglês
| MEDLINE
| ID: mdl-23962457
5.
Global Cancer Drug Development-A Report From the 2022 Accelerating Anticancer Agent Development and Validation Meeting.
JCO Glob Oncol;
9: e2300294, 2023 Sep.
Artigo
em Inglês
| MEDLINE
| ID: mdl-37944089
6.
Reliance is key to effective access and oversight of medical products in case of public health emergencies.
Expert Rev Clin Pharmacol;
15(7): 805-810, 2022 Jul.
Artigo
em Inglês
| MEDLINE
| ID: mdl-35945703
7.
WHO collaborative registration procedure using stringent regulatory authorities' medicine evaluation: reliance in action?
Expert Rev Clin Pharmacol;
15(1): 11-17, 2022 Jan.
Artigo
em Inglês
| MEDLINE
| ID: mdl-35130803
8.
Guidance for clinical trials for children and adolescents with chronic hepatitis C.
J Pediatr Gastroenterol Nutr;
52(2): 233-7, 2011 Feb.
Artigo
em Inglês
| MEDLINE
| ID: mdl-21076340
9.
Three years of paediatric regulation in the European Union.
Eur J Clin Pharmacol;
67(3): 245-52, 2011 Mar.
Artigo
em Inglês
| MEDLINE
| ID: mdl-21286912
10.
Pediatric regulatory initiatives.
Handb Exp Pharmacol;
205: 245-68, 2011.
Artigo
em Inglês
| MEDLINE
| ID: mdl-21882115
11.
Role of modeling and simulation in pediatric investigation plans.
Paediatr Anaesth;
21(3): 214-21, 2011 Mar.
Artigo
em Inglês
| MEDLINE
| ID: mdl-21244569
12.
Reliance: a smarter way of regulating medical products - The IPRP survey.
Expert Rev Clin Pharmacol;
14(2): 173-177, 2021 Feb.
Artigo
em Inglês
| MEDLINE
| ID: mdl-33355025
13.
Assuring Access to Safe Medicines in Pregnancy and Breastfeeding.
Clin Pharmacol Ther;
110(4): 941-945, 2021 10.
Artigo
em Inglês
| MEDLINE
| ID: mdl-33615448
14.
Paediatric investigation plans for pain: painfully slow!
Eur J Clin Pharmacol;
66(11): 1091-7, 2010 Nov.
Artigo
em Inglês
| MEDLINE
| ID: mdl-20821198
15.
Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors.
Birth Defects Res B Dev Reprod Toxicol;
89(6): 467-73, 2010 Dec.
Artigo
em Inglês
| MEDLINE
| ID: mdl-20632393
16.
Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
Clin Pharmacol Ther;
107(3): 507-513, 2020 03.
Artigo
em Inglês
| MEDLINE
| ID: mdl-31449664
17.
The European Medicines Agency facilitates access to medicines in low- and middle-income countries.
Expert Rev Clin Pharmacol;
13(3): 321-325, 2020 Mar.
Artigo
em Inglês
| MEDLINE
| ID: mdl-32053756
18.
The European paediatric initiative: 1 year of experience.
Paediatr Drugs;
11(1): 9-10, 2009.
Artigo
em Inglês
| MEDLINE
| ID: mdl-19127942
19.
What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.
Ther Innov Regul Sci;
52(2): 214-219, 2018 03.
Artigo
em Inglês
| MEDLINE
| ID: mdl-29714521
20.
Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.
Trials;
19(1): 642, 2018 Nov 20.
Artigo
em Inglês
| MEDLINE
| ID: mdl-30454061