Premium
Pharmacological screening of new chemical entities in human subjects and methods of data handling.
Author(s) -
Sullivan TJ,
Croft AR,
Hanka R,
Roberts SJ
Publication year - 1980
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.1980.tb01060.x
Subject(s) - computer science , volunteer , subject (documents) , drug , isoprenaline , medicine , data mining , pharmacology , biology , pathology , alternative medicine , library science , agronomy
1 A system is described for screening new chemical entities in normal human subjects, which is designed to search for novel drug actions at an early stage of drug development. 2 In single (subject) blind experiments, doses are increased incrementally from one subject to next, with immediate feed‐back of results from each dose. 3 As many physiological variables as possible are recorded, for which a purpose‐ designed apparatus system was constructed, and connected to a computer. 4 To overcome problems of inter‐subject variability, the need for sensitivity, and to identify drug‐related effects from the mass of data generated, a novel data management system was developed, and physiological profiles of volunteer subjects were built up to provide control data. 5 Results from a validation experiment in which isoprenaline was infused intravenously at different rates are presented and discussed.