Stephan O. Krause

发表

Good analytical method validation practice: Deriving acceptance criteria for the AMV protocol: Part II

Stephan O. Krause, 2003 .

How to maintain suitable analytical test methods : Tools for ensuring a validation continuum

Stephan O. Krause, 2005 .

Good analytical method validation practice: Data analysis and the analytical method validation report: Part III

Stephan O. Krause, 2003 .

Submitting advanced bioanalytical test methods for regulatory approval

Stephan O. Krause, 2005 .

Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products

Stephan O. Krause, R. Narwal, P. Cash, 2016, PDA Journal of Pharmaceutical Science and Technology.

Identification and Selective Inhibition of the Channel Mode of the Neuronal GABA Transporter 1

Stephan O. Krause, W. Schwarz, 2005, Molecular Pharmacology.

Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy

Stephan O. Krause, Jared S. Bee, S. Bishop, 2014, PDA Journal of Pharmaceutical Science and Technology.

STUDY ON AN INACTIVATION EVALUATION METHOD OF CLEANING PROCESSES FOR BIOPHARMACEUTICALS

Stephan O. Krause, H. Levine, H. Meyer, 2018 .

PCMO L01—Setting Specifications for Biological Investigational Medicinal Products

Stephan O. Krause, 2015, PDA Journal of Pharmaceutical Science and Technology.

Using Analytical Platform Technologies to Support Accelerated Product Development—Concept Review and Case Study

Stephan O. Krause, 2021, PDA journal of pharmaceutical science and technology.

A guide for testing biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance

Stephan O. Krause, 2006 .