title: A SAS/IML program for simulating pharmacokinetic data.
abstract: Data simulation can be an invaluable tool for optimizing the design of bioequivalence trials. It can be particularly useful when exploring alternative approaches for assessing product comparability especially in the context of encountering various complex experimental situations that can occur in veterinary medicine. With this in mind, we designed a novel SAS/IML program to generate pharmacokinetic datasets that reflect the various kinetic, population, and study design characteristics that complicate the bioequivalence evaluation of animal health products. Developing this simulation program within SAS provides an opportunity to utilize the statistical capabilities of this software platform.
authors.affiliation: Department of Animal and Avian Sciences, University of Maryland, College Park, MD 20742, USA. erussek@umd.edu
authors.forename: Estelle
authors.initials: E
authors.lastname: Russek-Cohen
authors.forename: Marilyn N
authors.initials: MN
authors.lastname: Martinez
authors.forename: Anna B
authors.initials: AB
authors.lastname: Nevius
mesh_terms: D000818:Animals; D019540:Area Under Curve; D035843:Biomedical Research; D003198:Computer Simulation / Q000706:statistics & numerical data*; D001330:Electronic Data Processing / Q000379:methods*; D009010:Monte Carlo Method; D010599:Pharmacokinetics; D012985:Software Design; D013810:Therapeutic Equivalency; D014481:United States; D019155:Veterinary Drugs / Q000493:pharmacokinetics*
chemical_list: D019155:Veterinary Drugs