Results 171 to 180 of about 1,296,267 (363)

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

Evaluation of the Medicines and Healthcare products Regulatory Agency's introduction of a risk‐proportionate approach for clinical trials: An analysis of 4617 applications assessed between September 2023 and August 2024

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims The Medicines and Healthcare products Regulatory Agency (MHRA) introduced a risk‐proportionate approach to assess clinical trial applications for authorisation in August 2023. This study evaluates the impact of this approach on the timelines for reviewing proposals.
Andrea Manfrin   +6 more
wiley   +1 more source

Safety, tolerability and pharmacokinetics of DNDI‐6148, a novel agent for leishmaniasis: A randomized, controlled, single ascending dose study in healthy participants

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The benzoxaborole derivative DNDI‐6148 is an antiparasitic agent with activity against multiple Leishmania protozoan species, including L. infantum and L. donovani, which cause visceral leishmaniasis. We investigated the safety, tolerability and pharmacokinetics of single oral doses of DNDI‐6148 in a randomized, parallel‐group, placebo‐controlled ...
Jean‐Yves Gillon   +12 more
wiley   +1 more source

Fostering medication review competence of pharmacy students: An assessment by students and their preceptors after advanced‐level practical internship

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims The aim of this study was to introduce a new assessment method for pharmacy students' real‐life competence in reviewing medications after obligatory advanced‐level practical internship in Finland. Methods The new medication review (MR) competence assessment method consisted of (1) a self‐assessment by pharmacy students and (2) a performance ...
Katja Leiman   +5 more
wiley   +1 more source

Drug poisonings following bariatric surgery: Case series report

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Bariatric surgery alters gastrointestinal anatomy and physiology, which likely impacts upon oral medication absorption. Drug‐ and alcohol‐related deaths in this population are being increasingly reported; however, toxicological detail is lacking. Using data reported to the National Programme on Substance Use Mortality, we identified 18 deaths in people
Eman Mshari   +3 more
wiley   +1 more source

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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