Regulatory Requirements for Bioequivalence

Clinical research means an investigation in human subjects, other than a non- interventional trial, which is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the medicinal products identify any adverse reactions to those medicinal products study absorption, distribution, metabolism and excretion of one or more such products  with the objective of ascertaining the safety or efficacy of  those products. Investigational used or assembled in a way different from the form of the product authorised under the authorization these are more useful in new drug development.

  • European Guidelines
  • FDA Guidelines
  • WHO Guidelines

Related Conference of Regulatory Requirements for Bioequivalence

July 03-04, 2017

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(10 Plenary Forums - 1Event)
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4th European Biopharma Congress

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