When performing uniformity of dosage units test for a tablet of combination drug, is it acceptable to take the lowest dosage unit component as the worst case to represent the uniformity of the drug product?

刊登日期：2019-11-22 | 點閱次數 : 1664 次

No. Uniformity of dosage units test applies to every drug substance in the product. The content uniformity procedure should be applied to every substance individually. However, if one or more drug substances meet the requirements of weight variation, it can be tested using the weight variation procedure.

(中文版)

	Regarding an acceptance criterion of "water content" specified for drug product,
	A pilot scale for solid oral dosage forms is generally not less than 100,000 fini

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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

When performing uniformity of dosage units test for a tablet of combination drug, is it acceptable to take the lowest dosage unit component as the worst case to represent the uniformity of the drug product?

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