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KMID : 1142220090040010059
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.59 ~ p.63
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Pharmaceutical Equivalence for Post Approval Changes
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Park Sang-Aeh
Kim Se-Eun
Kim Jung-Hyun
Park Seo-Jin
Lee Yoot-Mo
Kang Da-Hae
Kim Young-Ok
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Abstract
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Pharmaceutical Equivalence is the tests to prove that the generic drugs with the same active ingredient, strength and dosage form as reference product are pharmaceutical equivalent to reference products : which are bioequivalence, comparative dissolution test and comparative disintegration test. And it also includes the post approval change which is for 1) formulation changes 2) manufacturing changes 3) site changes. It has been 7 years since post approval change was performed and the understanding of that was changed a lot after that. But, because the post approval change is differently applied from each the character of products, active ingredients and dosage forms, it can be difficult to be accepted by industry. So we published the handbook of review for pharmaceutical equivalencewhich was constituted for the understanding of its regulation and application of variable cases to related regulations and we hoped it made the industry easier access the regulation.
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KEYWORD
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Pharmaceutical equivalence, Post approval change, Bioequivalence, Comparative dissolution test
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