Idioma:

Chapter 16 - The rigor of statistical analysis in assessing biophysical data: A lifecycle approach

Gabrielson, John P. ; Burdick, Richard K.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, 2020, p.481-504

Texto completo disponível

Citações Citado por

Título:
Chapter 16 - The rigor of statistical analysis in assessing biophysical data: A lifecycle approach
Autor: Gabrielson, John P. ; Burdick, Richard K.
Assuntos: Analytical target profile (ATP) ; FUV-CD spectroscopy ; Lifecyle approach ; Procedure performance criterion or criteria (PPC) ; Procedure performance qualification (PPQ) ; Reportable value ; Statistical test of variance ; SV-AUC ; System suitability ; Target measurement uncertainty (TMU)
É parte de: Biophysical Characterization of Proteins in Developing Biopharmaceuticals, 2020, p.481-504
Descrição: A “lifecycle approach”, consisting of three stages is used to describe statistical tools that are helpful in the study of a biophysical analytical procedure (method). The focus is on the Stage 2 Procedure Performance Qualification (PPQ) and the work to be accomplished in Stage 1 Procedure Design to ensure a successful qualification. Planning the appropriate statistical design and sample size for the PPQ based on Stage 1 experiments is addressed as well as the data analysis performed in the PPQ to demonstrate that a procedure is fit for purpose. Lastly, suitability tests are proposed for the Stage 3 Continued Procedure Performance Verification.
Editor: Elsevier B.V
Idioma: Inglês

Voltar para lista de resultados