Impact of switching on pharmacokinetics of therapeutic biologics and interchangeability assessment- a simulation study

Impact of switching on pharmacokinetics of therapeutic biologics and interchangeability assessment- a simulation study

The danger by way of security or diminished efficacy of switching between an originator organic product and a proposed interchangeable product is a vital consideration for interchangeability analysis within the regulatory framework. This simulation examine evaluated the impression of a number of switching examine design situations on the pharmacokinetic (PK) evaluation between a digital originator…

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