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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.
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.
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 clinicalresearch. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.
This approach underlies the identification of the OBD, backed by both clinical efficacy and drug tolerability data. Pharmacologically-guided dosing : Integrating pharmacokinetics (PK), pharmacodynamics (PD), and translational biomarkers into dose selection tailors drug administration regimens that maximize the therapeutic index of a drug.
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