Regulatory Requirements for BE

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BA/BE studies and conferences are required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product. BE studies are done for Early and late clinical trial formulations, Formulations used in clinical trial and stability studies,  if different Clinical trial formulations and to-be-marketed drug product When it comes to  cost and productivitymetrics, it’s often said that what gets measured gets done. Part of this is human nature. Everyone has more piled on their plate than ever, and many workers find themselves constantly re-prioritizing their work activities.

Global BA/BE studies market is projected to increase to nearly $35.3 billion by 2015 from $31.5 billion in 2014. This market is expected to reach $46.8 billion by 2020, corresponding to a compound annual growth rate (CAGR) of 5.8% during 2015 to 2020 period.

  • European Guidelines

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