Preclinical Research
2021 Year in Review
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In 2021, you did incredible things — and we are grateful to have been part of your journey. Nonclinical Assessment Planning Guide
Preclinical Strategies in Rodent Studies Using Volumetric Absorptive Microsampling (VAMS®)
Method for Surgical Closing of Muscle Biopsy Sites on Nonhuman Primates in Group Housing
Moving Your Drug Forward to Preclinical Trials
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Your drug discovery phase is nearing completion and your funding is in place. What comes next? Five Ways Altasciences Simplifies the Drug Development Process for You
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Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and costly process. Making Early-Phase Drug Development Faster, Better, and More Efficient
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Early-phase drug discovery and drug development are complex processes, where many moving parts can, and do, influence the success of a program. ISSUE NO. 19 — Hallucinogens, Psychedelics, Entactogens: Challenges Associated With Schedule 1 Therapeutic DevelopmentUnder the Controlled Substances Act (CSA) in the United States, drugs that have the potential to be abused are scheduled into one of five Classes or Schedules (CI-V) as controlled substances. The scheduling method makes a distinction between drugs that have abuse potential and are not approved for medical use (i.e., Schedule I) and drugs that are approved for medical use and have abuse potential (Schedules II-V). In the classification, the higher the number of the Schedule, the lower the abuse potential of the drug and the less restrictive the conditions regarding its distribution, storage, and prescribing. Schedule I, or Class I (CI), drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, both of which are Schedule I, is beginning to demonstrate the potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status. In Issue 19 of The Altascientist, we review:
Prioritizing the Compassionate Care of Research Animals
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The 3Rs of Animal ResearchThe 3Rs philosophy is the guiding principle for the Animal Welfare Program at Altasciences. ISSUE NO. 16 — Microsampling in Drug DevelopmentMicrosampling 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:
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