Format
Sort by
Items per page

Send to

Choose Destination

Search results

Items: 1 to 20 of 249

1.

A standardised framework to identify optimal animal models for efficacy assessment in drug development.

S Ferreira G, Veening-Griffioen DH, Boon WPC, Moors EHM, Gispen-de Wied CC, Schellekens H, van Meer PJK.

PLoS One. 2019 Jun 13;14(6):e0218014. doi: 10.1371/journal.pone.0218014. eCollection 2019.

2.

Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease.

Dekker MJHJ, Bouvy JC, O'Rourke D, Thompson R, Makady A, Jonsson P, Gispen-de Wied CC.

Front Med (Lausanne). 2019 May 7;6:73. doi: 10.3389/fmed.2019.00073. eCollection 2019.

3.

Achieving appropriate medication for older adults: A multidimensional perspective.

Mieiro L, Beuscart JB, Knol W, Van Riet-Nales D, Orlu M.

Maturitas. 2019 Jun;124:43-47. doi: 10.1016/j.maturitas.2019.03.007. Epub 2019 Mar 14. Review.

PMID:
31097178
4.

New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.

Ollivier C, Sun H, Amchin W, Beghetti M, Berger RMF, Breitenstein S, Garnett C, Gullberg N, Hassel P, Ivy D, Kawut SM, Klein A, Lesage C, Migdal M, Nije B, Odermarsky M, Strait J, de Graeff PA, Stockbridge N.

J Am Heart Assoc. 2019 May 21;8(10):e011306. doi: 10.1161/JAHA.118.011306. No abstract available.

5.

Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018.

van der Laan JW, Benson CT, Janssens W, Bos J, Stahl E, Brady JT, Wändel-Liminga U, Corriol-Rohou S, Forster R, Hartmann A, Pertel PE, Robertson SM, Silva-Lima B, Malik RE, Chibout SD.

Ther Innov Regul Sci. 2019 May 13:2168479019843514. doi: 10.1177/2168479019843514. [Epub ahead of print]

PMID:
31084267
6.

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications.

Lenić I, Blake K, Garcia-Arieta A, Potthast H, Welink J.

Clin Transl Sci. 2019 May 2. doi: 10.1111/cts.12642. [Epub ahead of print]

PMID:
31046182
7.

Comparison of toxicity and effectiveness between fixed-dose and body surface area-based dose capecitabine.

de Man FM, Veerman GDM, Oomen-de Hoop E, Deenen MJ, Meulendijks D, Mandigers CMPW, Soesan M, Schellens JHM, van Meerten E, van Gelder T, Mathijssen RHJ.

Ther Adv Med Oncol. 2019 Apr 15;11:1758835919838964. doi: 10.1177/1758835919838964. eCollection 2019.

8.

PDA Biosimilars Workshop Report (27-28Sep18) - Getting It Right the First Time for Biosimilar Marketing Applications.

Krause S, Lacana E, Welch JW, Shapiro M, Downey C, Chung J, Zhou Q, van der Plas RM, Depatie C, Ingram B, Srebalus-Barnes C, Polozova A, Rellahan B, Choi D, Burdick R, Stangler T, Shacter E.

PDA J Pharm Sci Technol. 2019 Apr 19. pii: pdajpst.2019.010215. doi: 10.5731/pdajpst.2019.010215. [Epub ahead of print]

PMID:
31004040
9.

The mechanisms of pharmacokinetic food-drug interactions - A perspective from the UNGAP group.

Koziolek M, Alcaro S, Augustijns P, Basit AW, Grimm M, Hens B, Hoad CL, Jedamzik P, Madla CM, Maliepaard M, Marciani L, Maruca A, Parrott N, Pávek P, Porter CJH, Reppas C, van Riet-Nales D, Rubbens J, Statelova M, Trevaskis NL, Valentová K, Vertzoni M, Čepo DV, Corsetti M.

Eur J Pharm Sci. 2019 Jun 15;134:31-59. doi: 10.1016/j.ejps.2019.04.003. Epub 2019 Apr 8.

10.

Age-Related Medicine.

Wahlich J, Orlu M, Mair A, Stegemann S, van Riet-Nales D.

Pharmaceutics. 2019 Apr 9;11(4). pii: E172. doi: 10.3390/pharmaceutics11040172.

11.

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study.

de Vries ST, Denig P, Ekhart C, Burgers JS, Kleefstra N, Mol PGM, van Puijenbroek EP.

Br J Clin Pharmacol. 2019 Apr 2. doi: 10.1111/bcp.13923. [Epub ahead of print]

PMID:
30941789
12.

Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR.

Pierce CE, de Vries ST, Bodin-Parssinen S, Härmark L, Tregunno P, Lewis DJ, Maskell S, Van Eemeren R, Ptaszynska-Neophytou A, Newbould V, Dasgupta N, Wisniewski AFZ, Gama S, Mol PGM.

Drug Saf. 2019 Apr;42(4):477-489. doi: 10.1007/s40264-019-00813-6.

13.

Level of evidence for promising subgroup findings: The case of trends and multiple subgroups.

Tanniou J, Smid SC, van der Tweel I, Teerenstra S, Roes KCB.

Stat Med. 2019 Jun 30;38(14):2561-2572. doi: 10.1002/sim.8133. Epub 2019 Mar 13.

PMID:
30868624
14.

Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study.

de Vries ST, Harrison J, Revelle P, Ptaszynska-Neophytou A, Radecka A, Ragunathan G, Tregunno P, Denig P, Mol PGM.

Drug Saf. 2019 Feb 6. doi: 10.1007/s40264-019-00800-x. [Epub ahead of print]

PMID:
30725337
15.

The effect of chitosan on the bioaccessibility and intestinal permeability of acyclovir.

Kubbinga M, Augustijns P, García MA, Heinen C, Wortelboer HM, Verwei M, Langguth P.

Eur J Pharm Biopharm. 2019 Mar;136:147-155. doi: 10.1016/j.ejpb.2019.01.021. Epub 2019 Jan 22.

PMID:
30682491
16.

Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study.

Minnema LA, Giezen TJ, Souverein PC, Egberts TCG, Leufkens HGM, Gardarsdottir H.

Drug Saf. 2019 Jan 8. doi: 10.1007/s40264-018-00789-9. [Epub ahead of print]

PMID:
30617497
17.

Post-marketing dosing changes in the label of biologicals.

Minnema LA, Giezen TJ, Gardarsdottir H, Egberts TCG, Leufkens HGM, Mantel-Teeuwisse AK.

Br J Clin Pharmacol. 2019 Apr;85(4):715-721. doi: 10.1111/bcp.13843. Epub 2019 Feb 16.

18.

A cost analysis of upfront DPYD genotype-guided dose individualisation in fluoropyrimidine-based anticancer therapy.

Henricks LM, Lunenburg CATC, de Man FM, Meulendijks D, Frederix GWJ, Kienhuis E, Creemers GJ, Baars A, Dezentjé VO, Imholz ALT, Jeurissen FJF, Portielje JEA, Jansen RLH, Hamberg P, Ten Tije AJ, Droogendijk HJ, Koopman M, Nieboer P, van de Poel MHW, Mandigers CMPW, Rosing H, Beijnen JH, van Werkhoven E, van Kuilenburg ABP, van Schaik RHN, Mathijssen RHJ, Swen JJ, Gelderblom H, Cats A, Guchelaar HJ, Schellens JHM.

Eur J Cancer. 2019 Jan;107:60-67. doi: 10.1016/j.ejca.2018.11.010. Epub 2018 Dec 11.

PMID:
30544060
19.

Baseline imbalances and clinical outcomes of atypical antipsychotics in dementia: A meta-epidemiological study of randomized trials.

Hulshof TA, Zuidema SU, van Meer PJK, Gispen-de Wied CC, Luijendijk HJ.

Int J Methods Psychiatr Res. 2019 Mar;28(1):e1757. doi: 10.1002/mpr.1757. Epub 2018 Dec 4.

PMID:
30515916
20.

Oncologic orphan drugs approved in the EU - do clinical trial data correspond with real-world effectiveness?

Schuller Y, Biegstraaten M, Hollak CEM, Klümpen HJ, Gispen-de Wied CC, Stoyanova-Beninska V.

Orphanet J Rare Dis. 2018 Nov 28;13(1):214. doi: 10.1186/s13023-018-0900-9.

Supplemental Content

Loading ...
Support Center