Clinical Trials
Clinical Applications of Hallucinogens, Dissociatives and Other Schedule I Drugs
Following an initial period of study, mainly in the early 20th century, many hallucinogenic drugs had been dismissed as drugs of abuse with no clinical utility.
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