Clinical Trials
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. Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials
Study Site Management: Eight Reasons to Choose Altasciences
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An important consideration in choosing a research partner for your drug development programs is their experience and expertise in managing their study sites. ISSUE NO. 14 — Central Nervous SystemAs you work towards a successful New Drug Application (NDA) submission, there are many considerations that must be taken into account, specifically for central nervous system (CNS)-active drugs. Molecules or compounds that are centrally active (the parent drug or metabolite[s]), may require additional evaluations to characterize the drug effects and unique safety characteristics. In Issue 14 of The Altascientist, we look into the complex considerations of CNS-active drugs, including:
THE IMPORTANCE OF CLINICAL STUDIES FOR CNS-ACTIVE DRUGSCNS-active drugs have unique attributes that necessitate additional specialized study, such as: Participant Retention Strategies in Phase I Clinical Trials
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In this article, we explore key participant retention strategies in Phase I clinical trials. |