Bioassay validation procedures, biologic reference standards control , PK studies, Phase I-III study protocols and SAPs. Experienced in "Design of Experiments" and "Quality by Design" guidelines, FDA, USP and EMEA guidelines.
Using the optimal statistical methodology, to maximize the information gained from the data. Experts in dose-time-response analysis, survival analysis techniques, classification trees, repeated measures analysis and analysis of highly multivariate data sets.
The analysis must be interpreted to be of use. Experience is essential to draw the correct and most helpful conclusions. Quantics has a huge breadth of experience in statistical interpretation of data.
The conclusions must be put into context, and presented so that they are clear and understood, phrased to answer the questions set at the start. Quantics will ensure that you understand what the analysis results really mean.
Better Bioassays: Using statistics to design, validate and understand bioassays
Download...
How to chose the best methods to study parallelism, using real bioassay data to model diferent possibilities and applications in the development of biologics