UpDate - Vol. 12, No. 38, Page 11
August 5, 1993
Statistics graduate receives award; department gets $10,000 grant

     Fred Snikeris, who received his doctorate in statistics from Delaware
in 1992, has received one of only five $10,000 Drug Information Association
Dissertation Summary Awards in recognition of his statistical analysis of
name-brand and generic drugs.
     The selection was made by the Drug Information Journal, the official
publication of the association.
     The Department of Mathematical Sciences, where the research was
conducted, also was awarded $10,000. Henry Tingey, professor of
mathematical sciences, who was Snikeris' adviser, said the money will be
added to a fund that enables graduate students to participate in scholarly
activities, such as presentations and conferences.
     Snikeris is employed by Sterling Winthrop Pharmaceuticals in
Collegeville, Pa., and his dissertation, "A Two-Step Method for Assessing
Bioequivalence," uses data from the company.
     After a name-brand drug with exclusive rights has been on the market
for a specified period of time, Snikeris said, generic drugs are developed
and tested. Less expensive for the manufacturer and consumers, these drugs
are similar but not identical to their name-brand counterparts.
     Through statistical modeling, Snikeris compares the bioavailability of
the name-brand drugs to the generic drugs.
     There are many variables in the manufacturing and processing of drugs,
and with his model, Snikeris can assess whether the generic drug is
comparable to the name-brand drug for testing and approval by the Food and
Drug Administration (FDA).
     Individual users react differently to the same drug, Snikeris pointed
out. Statistically, Snikeris can estimate both the mean and the variance of
the name-brand and generic drug to ensure that the generic is comparable to
the name-brand drug.
     "These probability studies using available data, such as blood levels,
are effective for assessing the bioequivalence of generic drugs and the
original name-brand drug. These methods can streamline further experimental
research and may become the standard procedures for assessment," Snikeris
said.
                                        -Sue Swyers Moncure