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RSSL
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University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
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Challenges of Analytical Method Transfer in the Pharmaceutical Industry
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The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
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Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate
The Phase 3 ENSEMBLE study (NCT04505722) of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enrol and vaccinate study participants. ENSEMBLE is proceeding to enrol up to 60,000 participants worldwide.1
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