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Non-clinical dose formulation considerations

15 December 2017 | By

Designing appropriate non-clinical safety studies requires thoughtful, and sometimes experimental, consideration of the delivery methodology for the therapeutic. The choice of formulation affects drug release and absorption and has a direct impact on the pharmacokinetic profile and associated response of the model system. The formulation should be compatible with the…

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Microbiology In-Depth Focus 2017

19 October 2017 | By

The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.