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main steps during a method transfer
Pharmaceutical Articles

Method Transfer, Its Importance, Complexities, and Future Trends

The USP chapter <1224> defines the method transfer or transfer of analytical methods (TAP) as a systematically documented process that allows a laboratory (receiving laboratory) to perform an analytical method that has been validated in another laboratory (source laboratory), hence ensuring that the new receiving laboratory has the knowledge, prowess, and resources to perform the transferred analytical method as intended. In contrast to analytical method validation, no detailed regulatory guidance exists for method transfer. Some high-level information is e.g. provided… Keep Reading

Clinical Trials and the Challenge of Plain Language Summaries
Pharmaceutical Articles

Clinical Trials and the Challenge of Plain Language Summaries

From 2019, pharmaceutical organizations will be expected to prepare plain-language summaries (PLSs), but creating these will not be a simple task. Pooja Phogat & Vidhi Vashisht of Kinapse examine the challenges companies face and explain why companies need to act now. From next year, life sciences companies will need to compile plain-language summaries (PLSs) for all Phase 1–4 interventional trials that can be easily understood by the general public, to comply with regulations for greater transparency and harmonization in the… Keep Reading

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