ABSTRACT
The ICH M7 Option 4 control of (potentially) mutagenic impurities is based on the use of scientific principles in lieu of routine analytical testing. This approach can reduce the burden of analytical testing without compromising patient safety, provided a scientifically rigorous approach is taken which is backed up by sufficient theoretical and/or analytical data. This paper introduces a consortium-led initiative and offers a proposal on the supporting evidence that could be presented in regulatory submissions.
Subject(s)
Drug Contamination/prevention & control , Mutagenicity Tests/standards , Mutagens/toxicity , Pharmaceutical Preparations/standards , Technology, Pharmaceutical/standards , Computer Simulation , Humans , Mutagenicity Tests/methods , Pharmaceutical Preparations/chemical synthesis , Practice Guidelines as Topic , Quality Control , Quantitative Structure-Activity Relationship , Risk AssessmentABSTRACT
Combining the Berends-Giele and on-shell recursion relations we obtain an extremely compact expression for the scattering amplitude of a complex massive scalar-antiscalar pair and an arbitrary number of positive helicity gluons. This is one of the basic building blocks for constructing other helicity configurations from recursion relations. We also show explicitly that the scattering amplitude of massive fermions to gluons, all with positive helicity, is proportional to the scalar one, confirming in this way the recently advocated SUSY-like Ward identities relating both amplitudes.
