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Combined prescription drugs required efficacy equivalent tests.
The KFDA extended the drug efficacy equivalent test requirements even to the combined prescription drugs by revising the rules of Drug Equivalent Test Administration as of Nov. 8.
The revised provision also made clear for the scope of the data to submit in case of changing the formula, process and the manufacturer's address.
The selection standards of the reference drugs for the equivalen...
The revised provision also made clear for the scope of the data to submit in case of changing the formula, process and the manufacturer's address.
The selection standards of the reference drugs for the equivalen...
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