Preclinical Research
Drug Development Timelines: How Health Canada’s 30-Day Regulatory Review Process Could Provide an Advantage
We want novel therapies to be approved fast, while being safe for us. Regulatory agencies around the world strive to balance the critical elements of speed and safety; at the same time, a rigorous review process is a must.
ISSUE NO. 33 — End-to-End CNS Drug Development Solutions
In Issue 33 of The Altascientist, we explore how a comprehensive, end-to-end integrated approach to drug development for central nervous system (CNS) therapeutics can take you seamlessly from lead candidate selection to market.
Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.
With detailed case studies, study considerations, and more, this Issue covers:
- preclinical safety and toxicity testing,
- formulation and manufacturing,
- early-phase clinical trials, and
- bioanalysis.
Development of a Flow Cytometry Phospho-STAT5 Assay in Nonhuman Primate T Cells
Strategies for Reducing the Number of Animals in Toxicity Testing: A Comparative Approach for Rodent and Large Animal Studies
Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors: Historical Data Review to Characterize Common Challenges and Identify Opportunities for Refinement
Comparison of Toxicology Assessment Baseline Data Collected Using Two Restraint Methods in Nonhuman Primates: Restraint Chair/Pole and Collar vs. Procedure Cage
Downsized Sinclair™ vs. Göttingen™ Minipigs Similarities and Differences of Toxicological Reference Range Data in Preclinical Safety Studies
Ocular Imaging and Microscopic Analysis of Focal Chorioretinal Defects in Rabbits
Validation of an SC5b-9 Commercial Kit for Preclinical Biomarker Analysis
Correlating Changes in Body Weights and Immune System Parameters in Cynomolgus Macaques