Results 21 to 30 of about 27,419 (207)
Biosimilars: potential implications for clinicians
Clinical, Cosmetic and Investigational Dermatology, 2016 Misty G Eleryan,1 Sophia Akhiyat,2 Monica Rengifo-Pardo,1 Alison Ehrlich,1,2 1Department of Dermatology, The George Washington Medical Faculty Associates, 2George Washington University School of Medicine & Health Sciences, Washington, DC, USA ...
Eleryan MG +3 more
doaj +4 more sources
JAMA Internal Medicine, 2023 Importance The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing ...
Xuan Wang +6 more
semanticscholar +1 more source
Drug, Healthcare and Patient Safety, 2015 Olaf GJ Naether,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Reproductive Endocrinology, MVZ Fertility Center Hamburg, Hamburg, 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, 3Medical Affairs, Fertility, Endocrinology and General ...
Naether OGJ +2 more
doaj +1 more source
Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance [PDF]
Diabetes & Metabolism Journal, 2023 Background To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.
Jun Sung Moon +12 more
doaj +1 more source
Real-World Use of Generic Meropenem: Results of an Observational Study
Antibiotics, 2021 Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
Santiago Garnica-Velandia +2 more
doaj +1 more source
The critical need for postmarketing surveillance in gene therapy for haemophilia
Haemophilia, 2020 The goal of gene therapy for haemophilia is to alter the clinical phenotype to a milder form or even cure, by increasing endogenous coagulation factor levels through transfer of a functional gene encoding the respective deficient coagulation factor and ...
B. Konkle, M. Recht, A. Hilger, P. Marks
semanticscholar +1 more source
Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins : A Regulatory Perspective [PDF]
, 2021 Background: Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines.
Tsantili, Panagiota +4 more
core +1 more source
Journal of Arrhythmia, 2021 Background Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).
Takeshi Yamashita +3 more
doaj +1 more source
Stepwise approach of development of dermo‐cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance [PDF]
Journal of the European Academy of Dermatology and Venereology, 2019 AbstractBackground/objectivesPaediatric skin, considered sensitive, and infant skin, more susceptible to percutaneous toxicity, require specially formulated cosmetic products. As recently shown, early use of emollients in infants “at risk” of developing atopic dermatitis has shown controversial results in reducing the incidence of atopic dermatitis ...
V. Ribet +5 more
openaire +2 more sources