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ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - Scientific guideline
Nhan đề ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - Scientific guideline
Tóm tắt This document provides guidance on bracketing and matrixing study designs in accordance with ICH guideline Q1A(R2). It defines specific principles for situations in which bracketing or matrixing can be applied. Sample designs are provided for illustrative purposes.
Từ khóa tự do Bracketing, matrixing
Từ khóa tự do Stability data
Địa chỉ Thư viện số Đại học Y Dược Thái Bình
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00164435
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245 |aICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - Scientific guideline
520 |aThis document provides guidance on bracketing and matrixing study designs in accordance with ICH guideline Q1A(R2). It defines specific principles for situations in which bracketing or matrixing can be applied. Sample designs are provided for illustrative purposes.
653 |aBracketing, matrixing
653 |aStability data
852 |aThư viện số Đại học Y Dược Thái Bình

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