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A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Wenlei Jiang, Fairouz Makhlouf, Donald J. Schuirmann, Xinyuan Zhang, Nan Zheng, Dale P. Conner, Lawrence X. Yu, Robert Lionberger

The AAPS Journal · 2015 · 63 citations · 4 references

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References

4

Power of the two one-sided tests procedure in bioequivalence

Kem F. Phillips · Journal of Pharmacokinetics and Biopharmaceutics · 1990 · 147 citations

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Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

Sam Haidar, Fairouz Makhlouf, Donald J. Schuirmann et al. · The AAPS Journal · 2008 · 103 citations · Full text

, , +13

Non-traditional study designs to demonstrate average bioequivalence for highly variable drug products

Scott D. Patterson, Névine Zariffa, Timothy H. Montague et al. · European Journal of Clinical Pharmacology · 2001 · 39 citations

, , +16

Determination of Bioequivalence for Drugs with Narrow Therapeutic Index: Reduction of the Regulatory Burden

László Endrényi, László Tóthfalusi · Journal of Pharmacy & Pharmaceutical Sciences · 2013 · 19 citations · Full text

, , +17