In this issue, we review complex considerations for the development of central nervous system-active drugs, including The Controlled Substances Act, preclinical and clinical data requirements, and additional assessments your program may need.

Click here to download a PDF, readable version of Issue 14: https://www.altasciences.com/sites/default/files/2020-08/The-Altascientist_issue-14_CNS_0.pdf

CHAPTERS:

- 0:24 — Section 1: Introduction

- 0:58 — Section 2: The Landscape

- 3:13 — Section 3: Drug Schedule and The Controlled Substances Act

- 6:39 — Section 4: Early Phase Preclinical and Clinical Study — Data Review

- 9:26 — Section 5: Significant Considerations for CNS Drug Development — Abuse Potential

- 11:07 — Section 6: Significant Considerations for CNS Drug Development — Physical Dependency and Withdrawal

- 14:01 — Section 7: Driving Impairment Assessment and Cognitive and Motor Function Effects

- 16:51 — Section 8: Additive Effects

- 14:40 — Section 9: Choosing a CRO for CNS Studies

About Altasciences:

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.