Regulatory Affairs
Five Facts About Psychedelics for Mental Health
As the incidence of mental health issues increases around the world, most recently exacerbated by the COVID-19 pandemic that has pushed depression to nearly triple the rate
The Impact of Social Factors on Drug Development
Drug development exists within the context of interrelated social factors that impact its norms and practices.
Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes
Three Key Advantages of Conducting Early-Phase Clinical Trials in North America: An Overview of the Webinar “A Hop Across the Pond”
Regulatory processes can be challenging, and potential solutions can be found in broadening your focus to include clinical sites in the U.S. and Canada for your drug development strategy. With an understanding of how regulatory agencies and market environments may differ, you will be in a better position to optimize your program. In Altasciences’ on-demand webinar, A Hop Across the Pond, Ingrid Holmes, Vice President of Global Clinical Operations, and Dr.
Psychedelics — Regulatory Environment Challenges
A History of Public Attitude Towards Psychedelic Drugs
Psychedelic drugs exist within a unique social, legal, and historical environment, with roots in the public imag
The Next Trip: Developing the Second Generation of Psychedelics and Their Analogs for Targeted Medical Use
Following decades of stagnation, the field of psychedelic research is being revitalized by the investigation of their potential benefit for mainstream psychiat
Moving Your Drug Forward to Preclinical Trials
Your drug discovery phase is nearing completion and your funding is in place. What comes next?
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.
Rigorous Sample Handling Processes
Regulatory Guidance
Ensuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical tria
From Lead Candidate to In-life Use
From Lead Candidate to In-life Use – Manufacturing Drugs from Formulation Development to Commercialization
Podcast Speakers:
Steve Schweibenz, President, Manufactur