Search results for " pharmaceutical"
Article
Manufacturers Struggle with Breakthrough Drug Development
About the Author
Jill Wechsler is Pharmaceutical Technology’s Washington editor. jwechsler@advanstar.com.
Article
Design of Experiments for Analytical Method Development and Validation
ICH, Q8(R2) Pharmaceutical Development (ICH, 2009)
3. ICH, Q9 Quality Risk Management (ICH, 2006).
4. T.A. Little, Assay Development and Method Validation (2014).
About the Author
Thom…
Article
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pha…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
The author highlights the top 10 outsourcing trends revealed during a survey of biopharmaceutical manufacturers.
The biopharmaceutical industry is changing the way it manufactures. According to …
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Joerg Windisch, EBG chair and chief science officer of Sandoz Pharmaceuticals, stressed that comparability between biosimilars and their reference products included having similar variabilities, parti…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
A team from Chugai Pharmaceutical (Japan) investigated the mAb purification performance of a new alkali-tolerant, prototype Protein A resin (Resin 3, MabSelect SuRe LX prototype, Cytiva), which has th…
Article
Essentials in Establishing and Using Design Space
ICH, Q8(R2) Pharmaceutical Development (2009).
2. FDA, Guidance for Industry, Process Validation: General Principles
and Practices (2011).
3. S. Chatterjee, “Design Space Considerations,” …
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
ICH, Q8 (R2) Pharmaceutical Development, Step 4 version (2009).
3. A. Brindle, et al., Pharm. Eng. 32 (1) 26, 28-33 (2012).
Article
PDA's Technical Report for Biotech Cleaning Validation
ICH, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Step 4 version (2000).
6. ICH, Q9 Quality Risk Management, Step 4 version (2005).
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Note: This article was fi…
Resource
Parenteral Drug Association
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded i…