Search results
Results from the WOW.Com Content Network
In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
Bioequivalence Studies in Drug Development: Methods and Applications. Statistics in Practice. Chichester, UK: John Wiley and Sons. pp. 17– 36. ISBN 978-0-470-09475-4; Chow, Shein-Chung; Liu, Jen-pei (15 October 2008). Design and Analysis of Bioavailability and Bioequivalence Studies. Biostatistics Series. Vol. 27 (3rd ed.).
Typical experimental design for measuring dose-response relationships are organ bath preparations, ligand binding assays, functional assays, and clinical drug trials. Specific to response to doses of radiation the Health Physics Society (in the United States) has published a documentary series on the origins of the linear no-threshold (LNT ...
A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...
Pharmacokinetics is based on mathematical modeling that places great emphasis on the relationship between drug plasma concentration and the time elapsed since the drug's administration. Pharmacokinetics is the study of how an organism affects the drug, whereas pharmacodynamics (PD) is the study of
Stateville Penitentiary Malaria Study – a controlled study of the effects of malaria on the inmates of Stateville Penitentiary near Joliet, Illinois. Tuskegee Study of Untreated Syphilis in the Negro Male – a clinical study, conducted between 1932 and 1972 in Tuskegee, Alabama studied the natural progression of the disease if left untreated.
The use of a sequence of experiments, where the design of each may depend on the results of previous experiments, including the possible decision to stop experimenting, is within the scope of sequential analysis, a field that was pioneered [12] by Abraham Wald in the context of sequential tests of statistical hypotheses. [13]
In medicine, a crossover study or crossover trial is a longitudinal study in which subjects receive a sequence of different treatments (or exposures). While crossover studies can be observational studies , many important crossover studies are controlled experiments , which are discussed in this article.