Bioequivalence and Bioequivalency Testing

@inproceedings{Balthasar2004BioequivalenceAB,
  title={Bioequivalence and Bioequivalency Testing},
  author={Joseph P Balthasar},
  year={2004}
}
PROLOGUE This lecture material is covered in one and one-half fiftyminute lecture periods. The primary objectives of the lecture are to: (i) review interpatient and intrapatient pharmacokinetic variability; (ii) introduce the concepts of therapeutic equivalence and bioequivalence; (iii) introduce the current FDA standards on bioequivalence; (iv) introduce the basic approach of bioequivalency testing; (v) provide an example of a clinical study assessing bioequivalence, showing calculations and… CONTINUE READING

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