What’s difference between equivalency study and evaluation study fda criteria about both study. Please help me
An equivalency study is demonstrating that your drug product is ‘equivalent’ (potency, purity, safety, effectiveness…) to the ‘originator’s’ reference listed drug (RLD). It is part of the FDA’s ANDA (abbreviated new drug application) when going generic.
A evaluation study can be anything else (almost) since you are not making a comparison. Example; Validation of an analytical method per ICH Q2 guideline.
Very correctly said by Boomer, equivalency is to compare your product with the other drug or device to prove it is equivalent in terms of safety or effectiveness.
However equivalency study is basically trying to judge the value of the product interms of structure, process and outcome. The purpose of the evaluation is to determine whether outcome criteria have been met and how care for the patient might be improved. Evaluation is not done to find fault or lay blame for inefficiency, incompetence, or carelessness. It is done for the purpose of improvement, by identifying specific areas that need change for the better.
What are the different types of tests that can be included in the Pharmaceutical Equivalence Study?
The same as required in your specifications like Assay, Related Compounds, Moisture…
Has anyone ever developed a paper or documentation in support of lab instrument and/or Assay equivalences. By this I mean when taking a risk based approach to validating a lab software system, such as a system which houses lab data, and there are over a hundred varying types of instruments (HPLC, GC, etc.) used in the Lab and connected to the system. The approach trying to be achieved is to execute protocol on instrument which may not be same model and/or instrument manufacturer. To support this approach we need a document which details how this instrument is equivalent to others within a family of instruments
Has anyone else taken this approach and if so, is there anyway to provide an example of something similar to a instrument equivalency?
Thanks!