This is a continuation of the post “The drug development process – Part 1” and “The drug development process – Part 2″
The 3 Phases of clinical trials are strictly monitored and controlled by different regulatory bodies such as the FDA (US), the TGA (Australia), the EMEA (EU) and SwissMedic.
All trials must undergo the same rigorous process as outlined in our previous post, but are quite distinctly different and influenced by a number of other factors.
Dr. Hank Agersborg is Clinuvel’s Chief Scientific Officer. With over 50 years working in the industry, his insights and experience span some of the most dynamic and exciting eras of change and evolution that this sector has seen.
In this interview he discusses the company’s regulatory strategy following the announcement of a confirmatory Phase III EPP study.
Click here to listen or download.
This is a continuation of the post “The drug development process – Part 1”
Clinical trial development must follow a strict and comprehensive process and there are different objectives and focuses for each phase. Generally, phase I trials assess the toxicity of a drug, while phase II focuses on in-depth study of the drugs activity with the chosen condition or indication. Phase III aims to prove the drugs efficacy (efficiency) as a treatment or cure for a condition. However, the safety of the drug is a common consideration throughout the entire process.
As we’ve said before, the drug development process is long and complex. There is always a measure of anticipation from the market and patients, but there is also an overwhelming amount of work involved. Ultimately the lengthy processes and protocols are there for two important reasons: to ensure safety and effectively demonstrate the drugs effectiveness and efficiency (efficacy).
Getting from the lab to the markets is no easy feat, and is neither fast, nor certain.
According to data from http://clinicaltrials.gov, for every new drug that makes it to market, 10,000 don’t. Where, when and why they fail varies greatly and is perhaps the best indication of just how fraught with challenges the development path is.
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