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
Why Does Sample Management Matter?
The proper handling of specimens (obtained from the trial participant) and samples (prepared for lab analysis), and their precise, timely treatment is crucial for reliable, robust data, and good decision making. When making a go/no-go decision for a new therapeutic, there must be certainty that the data which informs the decision is of the highest accuracy.
At both the bioanalytical site and the clinical site, meticulous workflows for safeguarding samples must be in place. Careful recording and storage of the samples, according to the study protocol and all relevant regulations and guidelines (e.g., GLP, GCP, ICH), is integral to the successful collection and analysis of trial data. Well-trained staff, managed by a dedicated bioanalytical Principal Investigator with a clear mandate to safeguard the integrity of the data, is a valuable asset.
Sample Collection and Storage Conditions
Preclinical studies and clinical trials can involve many different sample types, in a variety of storage containers. The sample containers for storage below -80 °C are specially developed with materials that retain their integrity under such conditions—a plastic cap that can be refrigerated may not withstand temperatures below -80 °C. Likewise, the container for a different type of sample and temperature will have its own qualities, specific to the situation. The necessity for adding stabilizers, anticoagulants, or other preservatives, either after collection or before bioanalysis, also varies depending on the specifics of each trial.
A comprehensive sample collection manual should be provided to the trial sites, detailing every requirement to ensure that all study personnel are fully proficient at maintaining specimen integrity. Flexibility to accommodate many variables with an equally rigorous workflow, and a readiness to learn and adopt the latest technologies, are key to a comprehensive sample management system that adapts to every sponsor’s needs.
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Five Facts About Psychedelics for Mental Health
As the incidence of mental health issues increases around the world, most recently exacerbated by the COVID-19 pandemic that has pushed depression to nearly triple the rate