Preclinical Research
Intraperitoneal Alfaxalone and Alfaxalone–Dexmedetomidine Anesthesia in Sprague–Dawley Rats (Rattus norvegicus)
ISSUE NO. 14 — Central Nervous System
As 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.
Not all centrally acting drugs require additional assessments; however, strategic direction early in a drug development program can help determine whether such studies should be planned or can be waived.
In Issue 14 of The Altascientist, we look into the complex considerations of CNS-active drugs, including:
- The landscape of CNS-active drug studies
- Drug scheduling and the Controlled Substances Act (CSA)
- Reviewing data from early-phase preclinical and clinical studies
- Choosing a CRO for CNS studies
THE IMPORTANCE OF CLINICAL STUDIES FOR CNS-ACTIVE DRUGS
CNS-active drugs have unique attributes that necessitate additional specialized study, such as:
Determination of Pirfenidone and Metabolites in Rat Plasma by Coupling On-Line Fractionation with LC-MS-MS
Microsampling - Making a Difference in Drug Development
Microsampling volume
Blood microsampling is a less invasive and simplified alternative to traditional venipuncture, and provides significant ad
Up Close and Personal with Francis Douville
Francis Douville joined the Altasciences team in 2018, as Senior Vice President, Technical Operations, for our preclinical services.
Making the Most of your CRO Partnership
Partnership
Choosing the right CRO as a partner for your drug development programs is a vitally important step to achieving critical decision making
Quiz – All About Investigational New Drug Submission
Test Your Knowledge —Investigational New Drugs
If you work in, or around, the early phase drug development landscape, you are likely aware of the requirements for an investigational new drug (IND) package.
ISSUE NO. 11 — Navigating the IND Submission Process
There are many challenges associated with early drug discovery and development. With timelines, budget, and market competition being critical factors, advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. In fact, we recommend initiating discussions with a CRO at least six months in advance to ensure that capacity, resource availability, and animal supply are built into your timelines.
In Issue 11 of The Altascientist, we provide a high-level overview of the preclinical component of your drug development program in preparation for regulatory submission, including:
- A submission checklist
- Pivotal toxicology studies
- Small molecules vs. biologics
- Considerations for before you begin (species selection, formulation, test article, bioanalysis, etc.)
- Small and large molecule timelines
- SEND data
- Selecting the right CRO for you
Preparing For Your IND Submission
Your IND application must contain information in the three following areas, as outlined by the U.S. FDA:
Use of Thromboelastography (TEG) in Preclinical Studies
Development of an IL-31-Induced Pruritus Model in Cynomolgus Monkeys