Preclinical Research

  • Preclinical Research
  • In drug development, toxicology evaluates and examines adverse effects of an investigational product on a living organism to determine its initial safety and dose-specific effects. But did you know that toxicology is not limited to drug development? Toxicology is a branch of science that deals with toxins and poisons, and their effects and treatment; other types of toxicology include forensic toxicology, environmental toxicology, food toxicology, and veterinary toxicology.

    Take this quiz to discover how much you know (or don’t know) about toxicology.

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    We are often asked about the advantages of working with an integrated CRO/CDMO.

    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

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    Your drug discovery phase is nearing completion and your funding is in place. What comes next?

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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.

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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.

    Under 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:

    • the regulatory environment and challenges (Drug Enforcement Administration
    • the research site requirements associated with the development of Schedule I drugs for therapeutic 
    • required preclinical studies of Schedule I drugs
    • required clinical studies of Schedule I drugs
    • specialized clinical assessments of Schedule I controlled substances
    • formulation, manufacturing, and analytical considerations for Schedule I drugs

     

     

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