Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
February 14, 2024
During drug development, a comprehensive regulatory strategy is key for saving time and money. There are many common...
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November 29, 2023
Don’t Forget the Development of Your Placebo: Overcoming Common Obstacles
A clinical trial is usually performed using some kind of comparator. This could be another drug on the market, or a...
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November 24, 2023
Epidemiological Methods to Tackle Real-World Evidence Challenges
Regulatory requirements regarding documentation for new medicines are constantly evolving. Previously, randomized...
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November 20, 2023
Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. While guidelines are...
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November 13, 2023
First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality
For nonclinical studies that precede Phase I, a drug formulation in high doses and concentrations is required. While...
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November 6, 2023
Ulrika Andersson on First-in-Human Clinical Trial Development
The first-in-human trial, which aims to show the safety and tolerability of a new drug, is a major milestone for any...
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September 11, 2023
How to Ask the Right Questions at an Authority Meeting
As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore,...
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June 20, 2023
New FDA Guidelines on Pediatric Studies and Potential Effects on Opportunities for Market Exclusivity
Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has...
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June 5, 2023
Maria Lundberg on a Holistic Approach to Therapeutics Development
Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative,...
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