1.What are some regulatory considerations that ABC Company should address prior

Question

1.What are some regulatory considerations that ABC Company should address prior to starting the phase III clinical trial if the Company intends to commercialize XYZ Drug product globally including in Japan and in European Union countries?

Scenario;------

ABC Company recently completed a multicenter, randomized, placebo-controlled, double blinded phase IIb clinical study to evaluate the safety and efficacy of one of its investigational drug product (XYZ Drug) in subjects with a rare disease. After reviewing preliminary safety and efficacy data from the phase IIb study, the decision was made to conduct a multinational phase III confirmatory clinical trial to support the marketing authorization application for XYZ Drug product.

Explanation / Answer

A drug can be released into the market for the public use only if the drug is for public health benefits without any inconveniences to the public, it should not affect ones physical and mental health.Clinical trails of the drug should comply with good clinical practice and ICH E6 guideline as adopted from the CHMP.The guidelines describe about the general governing principles of the clinical trials.The rights,safety and well being of the trails must prevail the interests over sciences.Trials must comply with the guidelines if the world medical association.

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