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.
ISSUE NO. 16 — Microsampling in Drug Development
Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic drugs, metabolites, and biomarkers in preclinical and clinical research.
In preclinical research, microsampling technology supports the 3Rs of animal research, and allows for less intrusive blood collection procedures.
By definition, clinical microsampling reduces sample volume to less than or equal to 50 microlitres (μL) compared to conventional venipuncture wherein millilitres (mL) of blood volume is collected. In Altasciences’ experience, microsample volumes being analyzed are less than or equal to 20 μL, with some microsampling techniques as low as 5 μL.
In Issue 16 of The Altascientist, we explore the benefits, applications, and considerations of microsampling in preclinical, clinical, and bioanalytical research, including:
- regulatory considerations
- case study: Anti-Epileptic Drug Monitoring – Sample Preparation Using Impact-Assisted Extraction
- case study: Large Molecule – Determination of Rituximab Using a Surrogate Peptide Approach
2020 Year in Review
2020 has been quite a year! Each year, we strive to provide you with a more innovative, simplified, and seamless early phase drug development journey. And the past 12 months have been no exception.
Clinical Applications of Hallucinogens, Dissociatives and Other Schedule I Drugs
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Following an initial period of study, mainly in the early 20th century, many hallucinogenic drugs had been dismissed as drugs of abuse with no clinical utility. |