Interpreting clinical laboratory data in safety assessment studies.
Traditionally, clinical laboratory data in safety assessment studies have been analyzed statistically to determine potential treatment-related effects. This has often led to inappropriate and/or controversial conclusions about clinical laboratory findings that are statistically significant but considered biologically unimportant. To overcome these problems, a decision-making process that integrates statistical analyses and sound medical judgement is required. Understanding the reasons why false-positive and false-negative results occur is the first step toward both better test selection and more accurate decisions on test material effects.
Carakostas
M C
MC
SmithKline Beecham Animal Health, West Chester, Pennsylvania 19380.
D000818:Animals; D006801:Humans; D010338:Pathology, Clinical / Q000706:statistics & numerical data*; D011336:Probability; D012016:Reference Values; D014116:Toxicology / Q000706:statistics & numerical data*