A weight of evidence approach for the non-clinical evaluation of complex biologicals

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The ICH S6 guideline (Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals states: “Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or combinations of these substances, or may be living entities such as cells and tissues”. 

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