Risk of false compliance/non-compliance decisions for sterility test due to false-negative and false-positive test results

da Silva, SB; Lourenco, FR

Lourenco, FR (corresponding author), Univ Sao Paulo, Fac Ciencias Farmaceut, Dept Farm, Av Prof Lineu Prestes,580 Bloco 15,Cidade Univ, Sao Paulo, SP, Brazil.

CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, 2020; 200 ():

Abstract

The sterility conditions of pharmaceutical products should consider the manufacturing conditions and the result obtained from a sterility test. The st......

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