Clinical Trials
Up Close and Personal with Dr. David Nguyen, MD, MBA
Dr.
Ethnobridging Supports Global Clinical Development
In our February 2021 blog we discussed protocol design concepts for ethnobridging in Phase I clinical trials.
Data Management Excellence – What it Takes
What Data Managers Do
Gathering, analyzing, and presenting the data to support life-altering new medicines for people around the world is a long, complex, and detailed proces
Effect of Difelikefalin, a Selective Kappa Opioid Receptor Agonist, on Respiratory Depression: A Randomized, Double-Blind, Placebo-Controlled Trial
ISSUE NO. 17 — Maximizing Drug Formulation for First-in-Human Trials
The main objective of first-in-human (FIH) trials is to determine the starting dose of a new drug, one that is low enough to provide minimal to no safety and toxicity risks and allows the highest dosage/benefit for the intended trial.
The manufacture of the drug product for clinical trials is of critical importance, as the formulation, manufacturing, and assessment of a drug candidate during FIH trials can
be contributing factors in whether the drug safely provides the correct dosage and, ultimately, gains regulatory approval. Decisions made during early-phase development, when the compound is being used in a clinical research setting, provide significant learnings for its progression through later phase research. Integration is key — ensuring that information gathered at the clinic is efficiently incorporated into the manufacturing process is a major contributor to the goal of achieving marketing approval.
In Issue 17 of The Altascientist, we review:
Leveraging the Benefits of Microsampling for Safety and Convenience
In a previous blog, we provided an overview of microsampling technology for preclinica
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Concomitant Administration of Multiple Doses of Cagrilintide With Semaglutide 2-4 mg for Weight Management
Up Close and Personal with Dr. Gaetano Morelli, MD
Dedicated to Medical training
He is a member of the Collège des Médecins du Québec, a Fellow of the Royal College of Physicians of Canada, certified in Internal Medicine and
Protocol Design Concepts in Phase I Ethnobridging Clinical Trials
In Phase I ethnobridging clinical trials, there are three primary protocol design concepts utilized.
