Validation of a computer software program for statistical analysis of accelerated stability studies on biological standards.
Long-term stability is an essential requirement for biological measurement standards and it has been evaluated by applying the Arrhenius model to the data obtained from accelerated thermostability studies. A computer program DEGTEST suited to a mainframe computer has been used for evaluating the stability of biological standards for more than a decade. This paper describes the validation of a computer program executable in a personal computer Microsoft Windows XP environment for the analysis of accelerated thermostability study data.
World Health Organization, Department of Immunization, Vaccines and Biologicals, CH-1211 Geneva 27, Switzerland. shinj@who.int
Jinho
J
Shin
Jusun
J
Nam
D001688:Biological Products / Q000592:standards*; D001699:Biometry; D004355:Drug Stability; D008838:Microcomputers; D011336:Probability; D012015:Reference Standards; D015203:Reproducibility of Results; D012984:Software; D013816:Thermodynamics
D001688:Biological Products