Asia-Pacific Journal of Clinical Oncology, EarlyView.A phase IV, single‐arm, open‐label, multicenter study assessing the safety and efficacy of trastuzumab emtansine in Indian patients for the treatment of human epidermal growth factor receptor 2 (HER2)‐positive unresectable locally advanced or metastatic breast cancer who received prior treatment with trastuzumab and a taxane.
Sudeep Gupta +13 more
wiley +1 more source
Pharmacogenetics of follicle‐stimulating hormone action in the male
Andrology, EarlyView.Abstract Male factor infertility (MFI) is involved in half of the cases of couple infertility. The follicle‐stimulating hormone (FSH) therapy is considered efficient to improve semen parameters and pregnancy rate in patients with idiopathic MFI, following the lesson learned from hypogonadotropic hypogonadism.
Andrea Graziani +7 more
wiley +1 more source
Novel approaches for drug development against chronic primary pain: A systematic review
British Journal of Pharmacology, EarlyView.Abstract Chronic primary pain (CPP) persisting for more than 3 months, associated with significant emotional distress without any known underlying cause, is an unmet medical need. Traditional or adjuvant analgesics do not provide satisfactory pain relief for a great proportion of these patients.
Valéria Tékus +5 more
wiley +1 more source
Glycosimilarity assessment of biotherapeutics 1: quantitative comparison of the N-glycosylation of the innovator and a biosimilar version of etanercept [PDF]
, 2018 K
Borza, Beáta +4 more
core
A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA (R)) to the reference product (Humira (R)) in patients with active rheumatoid arthritis [PDF]
, 2017 Background: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA (R), CinnaGen, Iran) to the innovator product (Humira (R), AbbVie, USA) in adult patients with active rheumatoid arthritis (RA).
Ahmadzadeh, Arman. +15 more
core +1 more source
Frontiers in Pharmacology, 2019 Biological therapies are an effective treatment for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.
D. Baumgart +3 more
semanticscholar +1 more source
Cancer Science, EarlyView.J‐MIND evaluated the safety and tolerability of tafasitamab, a CD19‐targeting monoclonal antibody, alone or in combination with other therapies in Japanese patients with B‐cell non‐Hodgkin lymphoma (NHL). Most common treatment‐emergent adverse events across all groups were hematological, and no serious tafasitamab treatment‐related or fatal adverse ...
Koji Izutsu +7 more
wiley +1 more source
Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial sustainability of healthcare systems.
Tabernero, Josep|| +18 more
openaire +3 more sources
Regulatory justifications: regulating European medicines to maximise market potential [PDF]
, 2016 The justification for regulating is generally considered to rely on benefitting interested groups. Whereas the traditional view is that regulators act as impartial arbiters balancing competing public and private interests, modern accounts consider ...
Warren-Jones, A.
core +1 more source
Biosimilar-Umstellung: Gesprächstechnik beeinflusst Bereitschaft der Patienten [PDF]
, 2020 openalex +1 more source