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Drugs producing over 100 thousand tablets eligible for bio-equivalent tests.
The drugs to take a bio-equivalent test should be submitted with more than 100 thousand tablets of test sample, which can be sold after the test pass.
The KFDA plans to reduce number of the test group by ingredients from 35 to 25 in order to enhance its efficiency.
Referring to Article 17(test and reference drugs), Paragraph 1, No. 3 of the revised ordinance of the Standard for Bio-eq...
The KFDA plans to reduce number of the test group by ingredients from 35 to 25 in order to enhance its efficiency.
Referring to Article 17(test and reference drugs), Paragraph 1, No. 3 of the revised ordinance of the Standard for Bio-eq...
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약업닷컴의 모든 컨텐츠는 저작권법의 보호를 받습니다. 무단 전재⋅복사⋅배포 등을 금합니다.