Clinical Trials
Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials
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.
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:
Participant Retention Strategies in Phase I Clinical Trials
In this article, we explore key participant retention strategies in Phase I clinical trials.
Safety Tolerability and Pharmacokinetics of GIC-1001 Following Multiple Ascending Doses Administrations Through an Adaptive First-in-Human Study in Healthy Volunteers
Cognitive Performance and Psychedelic Effects Following Single and Multiple Ascending Doses of a New Cannabis Formulation
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
Altasciences Fills Need of Leading Cancer Therapeutic Drug Developer
Polyvalent Human Immune Globulin: A Prospective, Open-Label Study Assessing Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety in HAV-Seronegative Healthy Subjects
Evaluation of the abuse potential of pitolisant, a selective H3-receptor antagonist/inverse agonist, for the treatment of adult patients with narcolepsy with or without cataplexy