Cargando…

Requirements for generic anti-epileptic medicines: a regulatory perspective

Detalles Bibliográficos
Autores principales:	Maliepaard, Marc, Hekster, Yechiel A., Kappelle, Arnoud, van Puijenbroek, Eugène P., Elferink, André J., Welink, Jan, Gispen-de Wied, Christine C., Lekkerkerker, Frits J. F.
Formato:	Texto
Lenguaje:	English
Publicado:	D. Steinkopff-Verlag 2009
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780669/ https://www.ncbi.nlm.nih.gov/pubmed/19603244 http://dx.doi.org/10.1007/s00415-009-5231-2

Ejemplares similares

Aggregated N-of-1 trials for unlicensed medicines for small populations: an assessment of a trial with ephedrine for myasthenia gravis
por: Weinreich, Stephanie S., et al.
Publicado: (2017)

Interchangeability of Generics—Experiences and Outlook Toward Pharmacokinetics Variability and Generic‐Generic Substitution
por: Yu, Yang, et al.
Publicado: (2018)

Regulatory scientific advice in drug development: does company size make a difference?
por: Putzeist, Michelle, et al.
Publicado: (2010)

Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease
por: Dekker, Marieke J. H. J., et al.
Publicado: (2019)

Future of the drug label: Perspectives from a multistakeholder dialogue
por: Gispen‐de Wied, Christine C., et al.
Publicado: (2019)

Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs
por: Glerum, Pieter J., et al.
Publicado: (2018)

Regulatory Scientific Advice on Non-Inferiority Drug Trials
por: Wangge, Grace, et al.
Publicado: (2013)

Run‐in periods and clinical outcomes of antipsychotics in dementia: A meta‐epidemiological study of placebo‐controlled trials
por: Hulshof, Tessa A., et al.
Publicado: (2019)

Pharmacokinetics and Generic Drug Switching: A Regulator’s View
por: Glerum, Pieter J., et al.
Publicado: (2020)

Regulatory and Health Technology Assessment Considerations for Disease-Modifying Drugs in Alzheimer’s Disease
por: Bouvy, Jacoline C., et al.
Publicado: (2018)

A comprehensive study on regulatory requirements for development and filing of generic drugs globally
por: Handoo, Shweta, et al.
Publicado: (2012)

Drug Shortages From the Perspectives of Authorities and Pharmacy Practice in the Netherlands: An Observational Study
por: Postma, Doerine J., et al.
Publicado: (2018)

Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines
por: Yu, Yang, et al.
Publicado: (2015)

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
por: Venkatesh, M., et al.
Publicado: (2011)

Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities
por: Thambavita, D., et al.
Publicado: (2018)

Baseline imbalances and clinical outcomes of atypical antipsychotics in dementia: A meta‐epidemiological study of randomized trials
por: Hulshof, Tessa A., et al.
Publicado: (2018)

Dose‐Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis
por: Schuller, Yvonne, et al.
Publicado: (2018)

Oncologic orphan drugs approved in the EU – do clinical trial data correspond with real-world effectiveness?
por: Schuller, Yvonne, et al.
Publicado: (2018)

PTEN Is Required for The Anti-Epileptic Effects of AMPA Receptor Antagonists in Chronic Epileptic Rats
por: Kim, Ji-Eun, et al.
Publicado: (2020)

Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus
por: Gantar, Kaja, et al.
Publicado: (2020)

Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective
por: Eckstein, Niels, et al.
Publicado: (2014)

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective
por: Borg, John Joseph, et al.
Publicado: (2014)

Factors Contributing to the Efficacy-Effectiveness Gap in the Case of Orphan Drugs for Metabolic Diseases
por: Schuller, Y., et al.
Publicado: (2017)

Regulatory Solutions to the Problem of High Generic Drug Costs
por: Luo, Jing, et al.
Publicado: (2015)

Scientific and Regulatory Considerations for the Approval of the First Generic Glucagon
por: Pang, Eric, et al.
Publicado: (2021)

Drug development for exceptionally rare metabolic diseases: challenging but not impossible
por: Putzeist, Michelle, et al.
Publicado: (2013)

Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland
por: O’Leary, A., et al.
Publicado: (2015)

Exploring the generic skills required for the employability and professional wellbeing of Pakistani Millennials: The employers' perspective
por: Iqbal, Jawad, et al.
Publicado: (2023)

Regulatory filing strategy for generic mesalazine modified release formulations
por: Gupta, Sandeep K.
Publicado: (2011)

Regulatory considerations for generic products of non-biological complex drugs
por: Liu, Yu-Hsuan, et al.
Publicado: (2023)

Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market
por: Sillo, Hiiti B., et al.
Publicado: (2018)

Correction: A standardised framework to identify optimal animal models for efficacy assessment in drug development
por: Ferreira, Guilherme S., et al.
Publicado: (2019)

A standardised framework to identify optimal animal models for efficacy assessment in drug development
por: S. Ferreira, Guilherme, et al.
Publicado: (2019)

Anti-infliximab antibodies are already detectable in most patients with rheumatoid arthritis halfway through an infusioncycle: an open-label pharmacokinetic cohort study
por: van den Bemt, Bart JF, et al.
Publicado: (2011)

Ephedrine as add-on therapy for patients with myasthenia gravis: protocol for a series of randomised, placebo-controlled n-of-1 trials
por: Vrinten, Charlotte, et al.
Publicado: (2015)

Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs
por: Hammami, Muhammad M., et al.
Publicado: (2017)

Reelin Is Required for Maintenance of Granule Cell Lamination in the Healthy and Epileptic Hippocampus
por: Orcinha, Catarina, et al.
Publicado: (2021)

Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands
por: Glerum, Pieter J., et al.
Publicado: (2020)

Perspectives on the Generic Cliff--Pushing and Falling
por: Curtiss, Frederic R.
Publicado: (2008)

The Epileptics
Publicado: (1901)

Cannot write session to /tmp/vufind_sessions/sess_b9r6tgic1nll0337p745vvjffa