Generics Consistency Evaluation

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  • Published date: May 23, 2019
    • Shirley, New York, United States

The generic consistency evaluation is composed by quality conformance and efficiency consistency. Evaluation of pharmaceutical quality conformance is defined to determine whether your generic drug preparation and reference formulations are consistent with the key quality indexes such as the dissolution and related substances. Treatment efficacy consistency is evaluated by bioequivalence assay.

In the field of generic quality consistency evaluation, we have successfully completed multiple quality consistency evaluation cases and generic drugs researches. With access to advanced techniques and excellent team members, the services including but not limited to: prescription evaluation/optimization, reference preparation dissolution similarity of different media, types of impurities/belonging, stability studies and guidance on the work of process validation. Finally, a comprehensive report of generics consistency evaluation will be offered for the supplementary application.

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