Variation in Biological Equivalency Tests among Generic Drugs

Therapeutic equivalency of generic antiepileptic drugs: results of a survey.

Controversy persists whether generic antiepileptic drugs (AEDs) are interchangeable with brand name drugs with respect to efficacy and adverse events. Three hundred and one neurologists responded to a survey regarding generic AEDs mailed to 6420 neurologists, for an overall response rate of 4.7%. One hundred and ninety-six (67.8%) neurologists reported breakthrough seizures after a switch from ...

Biological variation in tests of hemostasis.

The two components of biological variability are interindividual variability, which is the variability due to the heterogeneity of physiologic influences among subjects, and intraindividual variability, which is due to the variability in the same individual over time. Analysis of biological variation is crucial for estimating the critical difference, which corresponds with a threshold suggestiv...

Bioequivalence of generic drugs.

Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy o...

Biological false positive serological tests for syphilis among drug addicts.

Genomic tests of variation in inbreeding among individuals and among chromosomes.

We examine the distribution of heterozygous sites in nine European and nine Yoruban individuals whose genomic sequences were made publicly available by Complete Genomics. We show that it is possible to obtain detailed information about inbreeding when a relatively small set of whole-genome sequences is available. Rather than focus on testing for deviations from Hardy-Weinberg genotype frequenci...