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安定性試驗基準 - Coggle Diagram
安定性試驗基準
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試驗批次&批量
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先導性規模
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ex: 口服固體製劑,不得小於100,000劑型單位、但不得低於生產批量之1/10
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參考
FDA:
ANDAs: Stability testing of drug substances and products, Questions and answers
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