Results 81 to 90 of about 91,140 (235)

Has OMP legislation been successful? Yes, though the orphan drug market remains immature

open access: yesJournal of Market Access & Health Policy, 2019
Incentives for the development of Orphan Medicinal Products (OMP) development have been introduced in both the European Union and the US, yet there has been a relatively little investigation of the success of these policies.
Oriol Solà-Morales
doaj   +1 more source

Drug‐Induced Raynaud's Phenomenon and Underlying Mechanism: A Disproportionality Analysis From the World Health Organization Pharmacovigilance Database

open access: yesArthritis &Rheumatology, EarlyView.
Objectives The aim of this study is to generate hypotheses about unknown drugs associated with the onset or worsening of Raynaud's phenomenon (RP) and to explore their potential pathophysiologic mechanisms through a mixed disproportionality/clustering analysis from the World Health Organization (WHO) pharmacovigilance database.
Alex Hlavaty   +4 more
wiley   +1 more source

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

EMA [PDF]

open access: yesTechniques & culture, 2011
openaire   +3 more sources

Switching disease‐modifying therapies in patients with spinal muscular atrophy: A systematic review on effectiveness outcomes

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
With multiple disease‐modifying therapies now available, treatment switching has become an important clinical consideration in the management of spinal muscular atrophy (SMA). While some switches are prompted by suboptimal clinical response, more commonly they are driven by treatment burden, convenience, or adverse events.
Andrej Belančić   +4 more
wiley   +1 more source

Setting up mother–infant pair lactation studies with biobanking for research according to regulatory requirements

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Within the ConcePTION project we set out to design two mother–infant pair studies collecting breast milk and plasma from the mother and plasma from the infant (for metformin and prednisolone) in order to demonstrate the premises and conditions for investigating potential drug transfer in association with breastfeeding.
Mats Hansson   +11 more
wiley   +1 more source

Effect of enzalutamide on anticoagulant therapy with edoxaban in patients with prostate cancer

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Treatment with enzalutamide in prostate cancer is challenging due to its high potential for drug–drug interactions, particularly in the typically older population of patients with frequent comorbidities treated with multiple drugs, such as anticoagulants.
Catharina J. P. Op 't Hoog   +8 more
wiley   +1 more source

KEY TRENDS ANALYSIS OF RESULTS OBTAINED FROM INSPECTING THE FOREIGN MANUFACTURERS OF MEDICINAL PRODUCTS IN 2016

open access: yesРазработка и регистрация лекарственных средств, 2019
The matter presents a statistical evaluation of results obtained from GMP inspections of foreign pharmaceutical manufacturers held by Russian GMP-inspectorate in the year 2016.
V. A. Orlov
doaj  

Low‐dose cannabidiol increases plasma concentrations of amitriptyline: A clinical drug–drug interaction study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Cannabidiol (CBD), the main non‐intoxicating compound from the cannabis plant, is regularly used by patients with chronic pain who also take analgesics. CBD has previously been shown to inhibit CYP‐mediated drug metabolism. This study aimed to characterize the potential pharmacokinetic interaction of CBD with amitriptyline and tramadol ...
Andriy A. Gorbenko   +9 more
wiley   +1 more source

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