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
Diabetes and cardiovascular diseases (CVD) often appear as two sides of a coin. Diabetologists and cardiologists join their forces in a supply grid to improve the quality management in diagnosis and care in accordance with section 140a-d SGB V in the version from January 1, 2004. An algorithm was developed to help discover CVD in patients with diabetes and vice versa the metabolic diseases in patients with CVD, setting the basis for appropriate joint therapy.
