Search PubMed⌕ Search

Biomedical subjects

M S Tydeman

Publications and source records attributed to M S Tydeman.

7 recordsLinked to original sources
PubMed1984

Design and analysis of accelerated degradation tests for the stability of biological standards I. Properties of maximum likelihood estimators.

The accelerated degradation test is commonly used to predict the stability of a biological standard during long-term storage at low temperatures. The analysis of complicated by the fact that the standard generally defines its own unit of activity, so only relative rates of degradation at different temperatures can be observed. A series of Monte Carlo simulation studies is described which has been carried out to investigate the accuracy and precision of estimates based on the statistical method and are of use in assessing the extent to which the size and design of the accelerated degradation test influence the precision of the estimate of the low temperature degradation rate.

Biological Products↗
PubMed1984

Design and analysis of accelerated degradation tests for the stability of biological standards II. A flexible computer program for data analysis.

The accelerated degradation test is commonly used to predict the stability of a biological standard during long-term storage at low temperature. A flexible computer program is described which has been written to analyse degradation test results by the method of maximum likelihood. In addition to predicting the degradation rate at low temperature, the program furnishes estimates of statistical precision and it carried out a test of goodness of fit of the data to the assumed Arrhenius equation model.

Biological Products↗
PubMed1983

Standardization of Factor VIII-III. Establishment of a stable reference plasma for Factor VIII-related activities.

An international collaborative study has been carried out to establish a reference plasma for Factor VIII-related activities. The freeze-dried reference plasma, coded 80/511, was assayed against fresh normal plasma, local standards and another freeze-dried plasma. There was good agreement between laboratories for the comparison of the two freeze-dried plasmas, but wide variation in the comparison of plasma 80/511 with fresh normal plasma and local standards, indicating the differences in Factor VIII content of local pooled plasmas. There were no significant differences between the one-stage and two-stage assays of VIII:C, or between electroimmunoassay (EIA) and immuno-radiometric (IRMA) assays of VIII:Ag. However, in VIII R:RCoF (ristocetin co-factor) assays, the aggregometry methods gave lower values than the macroscopic and counting methods for the comparison of freeze-dried against fresh normal plasmas. From the combined results of assays against each laboratory's fresh normal plasma, potencies were assigned to plasma 80/511 as follows: VIII:C 0.73 VIIIR:Ag 0.87 International Units VIIIR:RCoF 0.80 per ampoule VIIIC:Ag 0.95. Results from accelerated degradation studies indicated that losses of each VIII-related activity in plasma 80/511, when stored at -20 degrees C, should be less than 0.01% per year, indicating its suitability to serve as a long-term reference preparation. Plasma 80/511 has been established by the WHO Expert Committee on Biological Standardization as the 1st International Reference Preparation for Factor VIII-Related Activities in Plasma.

Antigens↗
PubMed1982

Iterative weighted regression analysis of logit responses: a computer program for analysis of bioassays and immunoassays.

A program, WRANL, is described for the analysis of immunoassays or bioassays which have a logistic dose-response relationship. Responses are transformed to logits and iterative weighted regression analysis is used to obtain log dose-logit response lines for all preparations compared in an assay. Potency estimates of preparations relative to the standard preparation are available for both unweighted and weighted regression analyses together with detailed analysis of variance, estimates of slope and other relevant parameters. The general comparisons of dose-response relationships produced by the program are a feature of particular interest. However, an option which suppresses the more general output is available if the program is to be used for analysis of a 'screening' assay comparing single dilutions or doses of test samples with a standard curve. Data input is designed to permit immediate running of the program by junior personnel. Data output is designed to facilitate record keeping.

Biological Assay↗
PubMed1981

International collaborative study on the assay of commerically available high and low molecular weight urokinases.

Urokinases of different molecular weights are now commerically available. An international collaborative study (eight laboratories) has been conducted to investigate the effect of type and concentration of plasminogen on the assay of two different urokinase preparations against the International Reference Preparation (IRP). Considerable inter-laboratory variation in relative potency estimation was found, and a small effect of plasminogen concentration, independent of type, was apparent.

Biological Products↗