ASAPprime® for Clinical Regulatory Filings

In the development of new drugs, the process of getting drug candidates into clinical trials is often very time sensitive.  In a number of cases, setting expiration dates (use periods) for clinical materials becomes gating.  At FreeThink, we have used our ASAPprime® software in conjunction with stability studies either in our laboratories or at the sponsor pharmaceutical/biotech company (or a combination of the two) to successfully speed the process of getting into early clinical trials.  Here’s how:

  1. Conduct an ASAPprime® trial on prototypes of the drug product, non-GMP (3-6 weeks)
  2. Assign a 12-month use period based on >95% confidence that the product will remain within specifications
  3. File IND using ASAPprime® models
  4. Manufacture clinical supplies, dating at 1 year
  5. Place clinical material on traditional (ICH) stability program, but only analyze samples if queried by regulatory authorities

 

Using this process, companies have reported that the following regulatory agencies have allowed the clinical trial to proceed without queries:
US, Canada, Bulgaria, France, Holland, Hungary, India, Italy, Japan, Philippines, Romania, Serbia, Slovakia, South Africa, Spain, Taiwan, Turkey, UK

There were queries/objections at the following regulatory agencies:
South Korea, Czech Republic, Ukraine, Germany

At FreeThink, we have the experience to work with internal regulatory leadership to develop an appropriate strategy for getting new chemical entities into clinical trials as fast as possible.  We can also directly conduct the supporting cGMP studies in our laboratories.

 

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