Search results for " pharmaceutical" in Articles / App Notes
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
ICH, ICH Harmonized Tripartite Guideline Q8: Pharmaceutical Development, Step 4 version (August 2009).
2. A. S. Rathore, Trends Biotechnol. 27 (12) 698-705 (2009).
3. A. S. Rathore and H. Wink…
Article
FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
Article
Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Can you talk to us about the state of continuous processing in biotechnology?
A: Yes, the event is the International Symposium on Continuous Manufacturing of Pharmaceuticals (May 20-21, 2014…
Article
Trends in BioPharma Approvals in 2013
Ovaleap (Teva Pharmaceuticals) is the first biosimilar follicle stimulating hormone (FSH) to be approved; it will compete with two FSH products already marketed in Europe (Merck-Serono’s Gonal-f and O…
Article
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
Manufacturers Struggle with Breakthrough Drug Development
About the Author
Jill Wechsler is Pharmaceutical Technology’s Washington editor. [email protected].
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 …