Search results for " conference" in Articles / App Notes
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
Article
Evaluating Design Margin, Edge of Failure and Process
International Conference on Harmonization (ICH) Q8(R2), 3.0 Glossary defines design space as follows (1):
“Design Space: The multidimensional combination and interaction of input variables (e.g., …
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Global Expansion Shapes Drug Oversight
These entities hold conferences and training courses on quality manufacturing and testing, as seen in a program this month on parenteral manufacturing in Istanbul.
The Drug Information Association …
Article
Challenges in Analytical Method Development and Validation
Guo (FDU): The International Conference on Harmonization (ICH) has a general guidance on method validation, ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology (3). This is the guida…
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Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
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Q&A with Industry Leaders: Rita Peters
Q: What trends have you seen in the drug development market as 2014 enters the second quarter?
A; At recent industry conferences and trade shows for pharmaceutical development, both educational se…
Article
Design of Experiments for Analytical Method Development and Validation
A systematic approach for using DOE for analytical method development and validation is discussed in this paper and was written in line with the International Conference of Harmonization (ICH) Q2(R1),…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of paramet…