It is a one-sided hypothesis testing process for assessing bioequivalence. Bootstrap and modified large-sample(MLS) methods are considered to study individual bioequivalence(IBE), type I error and power of hypothesis tests are simulated and compared with FDA(2001). The results show that modified large-sample method is equivalent to the method of FDA(2001)
[[abstract]]The approval of generic drugs requires the evidence of average bioequivalence (ABE) on b...
For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequiva...
It is shown that the standard two one-sided tests procedure for bioe-quivalence is a biased test. Be...
It is a one-sided hypothesis testing process for assessing bioequivalence. Bootstrap and modified la...
Statistical criterion for evaluation of individual bioequivalence (IBE) between generic and innovati...
Statistical criterion for evaluation of individual bioequivalence (IBE) between generic and innovati...
Statistical criterion for evaluation of individual bioequivalence (IBE) between generic and innovati...
International audiencePURPOSE: The main objective of this work is to compare the standard bioequival...
Bioequivalence of two medicinal, or veterinary, products is established by comparing the mean of bio...
A simple three-step approach for the assessment of bioequivalence is proposed. According to the deci...
Average bioequivalence is used to assess pharmacokinetic properties of proposed generic drug before ...
Statistical methods to assess bioequivalence of a test and a reference formulation for modified-rele...
Reference-scaled average bioequivalence (RSABE) has been recommended by Food and Drug Administratio...
recommends that population bioequivalence (PBE) and individual bioequivalence (IBE) be assessed to a...
Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bi...
[[abstract]]The approval of generic drugs requires the evidence of average bioequivalence (ABE) on b...
For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequiva...
It is shown that the standard two one-sided tests procedure for bioe-quivalence is a biased test. Be...
It is a one-sided hypothesis testing process for assessing bioequivalence. Bootstrap and modified la...
Statistical criterion for evaluation of individual bioequivalence (IBE) between generic and innovati...
Statistical criterion for evaluation of individual bioequivalence (IBE) between generic and innovati...
Statistical criterion for evaluation of individual bioequivalence (IBE) between generic and innovati...
International audiencePURPOSE: The main objective of this work is to compare the standard bioequival...
Bioequivalence of two medicinal, or veterinary, products is established by comparing the mean of bio...
A simple three-step approach for the assessment of bioequivalence is proposed. According to the deci...
Average bioequivalence is used to assess pharmacokinetic properties of proposed generic drug before ...
Statistical methods to assess bioequivalence of a test and a reference formulation for modified-rele...
Reference-scaled average bioequivalence (RSABE) has been recommended by Food and Drug Administratio...
recommends that population bioequivalence (PBE) and individual bioequivalence (IBE) be assessed to a...
Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bi...
[[abstract]]The approval of generic drugs requires the evidence of average bioequivalence (ABE) on b...
For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequiva...
It is shown that the standard two one-sided tests procedure for bioe-quivalence is a biased test. Be...
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