所以，看到生物等效性的文献或说明书之类的，个体内变异系数大于或接近0.30时，就很可能是高变异药物。
另外，FDA的网站上，如Esomeprazole Magnesium Delayed Release Capsule/Oral的标准中，就有Additional Comments: Applicants may c**ider using a reference-scaled average bioequivalence approach for esomeprazole. If using this approach, please provide evidence of high variability in the bioequivalence parameters of AUC and/or Cmax (i.e.,
within-subject variability ≥ 30%). Please refer to the Progesterone Capsule Draft Guidance for additional information regarding highly variable drugs.
所以，看到生物等效性的文献或说明书之类的，个体内变异系数大于或接近0.30时，就很可能是高变异药物。
另外，FDA的网站上，如Esomeprazole Magnesium Delayed Release Capsule/Oral的标准中，就有Additional Comments: Applicants may c**ider using a reference-scaled average bioequivalence approach for esomeprazole. If using this approach, please provide evidence of high variability in the bioequivalence parameters of AUC and/or Cmax (i.e.,
within-subject variability ≥ 30%). Please refer to the Progesterone Capsule Draft Guidance for additional information regarding highly variable drugs.
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