Drug Discovery World

JULY 25, 2023

General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022. The guidance covers three main areas: clinical pharmacology considerations, ethical considerations, and the paediatric study plan design including points to consider.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

Alta Sciences

AUGUST 28, 2023

The trial was performed at Altasciences’ clinical facility in Montréal. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. Altasciences helps sponsors get better drugs to the people who need them, faster.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

Clinical Trials 40

Clinical Trials Drugs Trials Pharmacokinetics 40