Clinical Trials
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.
Five Reasons to Choose Canada for Your Clinical Trials—From the Webinar Demystifying the Conduct of Clinical Trials in Canada
Canadian research facilities are becoming a popular choice for American and European sponsors, carrying out hundreds of clinical trials each year.
Scratching the Surface of Dermal Testing
New Generation Pain Relief Without Opioids
Opioids are highly effective at relieving both acute and chronic pain. However, this benefit comes at a significant cost: they are also highly addictive.
Ophthalmic End-to-End Drug Development Solutions
ISSUE NO. 29 — Building Your Early Phase Clinical Data, from Protocol to Regulatory Submission
Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.
In this journal, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.
In Issue 29 of The Altascientist we explore:
- Protocol development
- Data management
- Statistical support
- Analysis and reporting
Inside the Pharmacodynamic Toolbox: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
ISSUE NO. 28 — Applications of Liquid-Filled Hard-Shell Capsules in Drug Development
Liquid-filled hard-shell capsules (LFHCs) are a popular formulation for oral solid delivery of chemical drugs and nutraceuticals. Often selected for drugs with poor solubility/bioavailability, LFHCs also have applications in a number of other situations, including specific benefits during early-phase clinical development.
In Issue 28 of The Altascientist, you will find:
- Applications of LFHCs
- The production process
- The role of excipients
- Other advantages of LFHCs A case study
- How Altasciences can help
Case Study― Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of Palovarotene (POS)