Study Site Management: Eight Reasons to Choose Altasciences
An important consideration in choosing a research partner for your drug development programs is their experience and expertise in managing their study sites.
Rigorous Sample Handling Processes
Regulatory Guidance
Ensuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical tria
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:
From Lead Candidate to In-life Use
From Lead Candidate to In-life Use – Manufacturing Drugs from Formulation Development to Commercialization
Podcast Speakers:
Steve Schweibenz, President, Manufactur
Participant Retention Strategies in Phase I Clinical Trials
In this article, we explore key participant retention strategies in Phase I clinical trials.
Altasciences Full-Service Clinical Trial and Bioanalytical Support
We had the pleasure of working with the Altasciences team on a relative bioavailability study, including clinical pharmacology and bioanalytical analysis, for a treatment for palmoplantar pustulosis (PPP), a rare, chronic inflammatory skin condition with no approved therapy in the United States.