RT Journal Article SR Electronic T1 Implementation of Parallelism Testing for Four-Parameter Logistic Model in Bioassays JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 262 OP 269 DO 10.5731/pdajpst.2012.00867 VO 66 IS 3 A1 Harry Yang A1 Hyun Jun Kim A1 Lanju Zhang A1 Robert J. Strouse A1 Mark Schenerman A1 Xu-Rong Jiang YR 2012 UL http://journal.pda.org/content/66/3/262.abstract AB Parallelism is a prerequisite for the determination of relative potency in bioactivity assays. It involves the testing of similarity between a pair of dose-response curves of reference standard and test sample. The evaluation of parallelism is a requirement listed by both the United States Pharmacopeia (USP) and European Pharmacopeia (EP). The revised USP Chapters 〈1032〉 and 〈1034〉 suggest testing parallelism using an equivalence method. However, implementation of this method can be challenging for laboratories that lack experience in statistical analysis and software development. In this paper we present a customized assay analysis template that is developed based on a fully good manufacturing practice (GMP)-compliant software package. The template allows for automation of the USP-recommended equivalence parallelism testing method for 4PLmodel in bioassays. It makes the implementation of the USP guidance both practical and feasible. Use of the analysis template is illustrated through a practical example. LAY ABSTRACT: Parallelism is a prerequisite for the determination of relative potency in bioactivity assays. It involves the testing of similarity between a pair of dose-response curves of reference standard and test sample. The evaluation of parallelism is a requirement listed by both the United States Pharmacopeia (USP) and European Pharmacopeia (EP). The revised USP Chapters 〈1032〉 and 〈1034〉 suggest testing parallelism using an equivalence method. However, implementation of this method can be challenging for laboratories that lack experience in statistical analysis and software development. In this paper we present a customized assay analysis template that is developed based on a fully good manufacturing practice (GMP)-compliant software package. The template allows for automation of the USP-recommended equivalence parallelism testing method for 4-parameter logistic model in bioassays. It makes the implementation of the USP guidance both practical and feasible. Use of the analysis template is illustrated through a practical example.