ISSUE NO. 24 — Shortening Drug Development Timelines with Asian Ethnobridging Trials
Conducting ethnobridging studies locally, during Phase I clinical trials, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases II and III) without repeating Phase I development in that region and population.
In Issue 24 of The Altascientist:
- The importance of Asian ethnobridging in clinical research
- Bridging requirements per the ICH E5 Guidance
- Strategic program considerations per the ICH E7 Guidance
- Accelerating Asian drug development
- Language requirements for global clinical trials
- Altasciences’ expertise and experience with ethnobridging
Future Science: Diversity and Inclusion in the Bioanalytical Industry — An Interview with Anahita Keyhani
Test Your Knowledge of Liquid-Filled Capsules
Thanks to updated screening methods and bioavailability enhancements, poorly soluble molecules comprise 70% to 80% of the small molecule products entering the drug development pipeline today. Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution.
Methodological Considerations for the Human Abuse Potential Evaluation of Emerging Drug Therapies with Psychedelic Properties
Key Biomarkers of Immunomodulation: Complement Factors and Cytokines
Quantitation of the COVID-19 Neutralizing Antibody Bamlanivimab* Using Mitra® Microsampling and Mass Spectrometry
Comparing Cytokine Data to In-Life Parameters on Nonhuman Primates in Nonclinical Toxicology Studies
Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol
The Advantages of Liquid-Filled Capsules Over Tablets in All Phases of Drug Development
ISSUE NO. 23 — Robust Sample Management for Reliable Study Results
The quality of study data depends on a rigorous sample management process that safeguards the integrity of samples at every step, from initial specimen collection through bioanalysis, to post-study storage. A CRO partner that conducts both preclinical and clinical studies, and supporting bioanalysis, ensures continuity of processes, knowledge sharing, and a centralized location for long-term storage of all your samples.
Issue 23 of The Altascientist provides a deep dive into:
- sample collection and storage conditions
- standardized workflows for risk Management and chain of custody
- stability testing
- laboratory management
- customized processes
- management of bioanalytical matrices
- post-study sample management