Related Experiment Video
Updated: Nov 8, 2025

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Validation Is Not Verification: Precise Terminology and Scientific Methods in Bioprocess Modeling
Jens Smiatek1, Alexander Jung2, Erich Bluhmki3
1Institute for Computational Physics, University of Stuttgart, D-70569 Stuttgart, Germany; Digitalization Development Biologicals CMC, Boehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), Germany.
Abstract:
Advanced statistical approaches and new modeling procedures for biopharmaceutical development and manufacturing have received increasing attention. With this forum article, we would like to highlight the need for a consistent terminology and the necessity for appropriate model validation strategies.
More Related Videos
08:31Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
20:24Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study
Published on: January 31, 2014
Related Concept Videos
Data Validation
Key parameters for method validation include:
Data Validation
Nursing assessment guides are generally based on holistic models rather than medical...
Pharmacokinetic Models: Comparison and Selection Criterion
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Accuracy and Precision
Typical Model Studies
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...