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JonJonesFrom the FDA

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georgejjl   Sunday, 05/19/19 05:42:31 PM
Re: Jonjones325 post# 193364
Post # of 232562 
JonJones

From the FDA

Quote:
Sources of Safety Information
• Clinical trial data for the indication
• Nonclinical data (CMC, in vitro, animals)
• Clinical Pharmacology studies
• Clinical trial safety data for other indications
• Postmarketing experience
• Medical literature
• Safety profile of other drugs in the same class



https://www.fda.gov/media/84954/download

From the EU

Quote:
Phase III

If previous trials have indicated a treatment is safe and that it also shows promise in being able to treat a condition, phase III clinical trials begin. These involve large numbers of participants usually from several hundred to several thousand subjects, and are often
spread between different hospitals and countries. If these trials show that a drug is safe and effective, the manufacturers can apply for a drug license.



https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf

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