Search results for " FDA" in Articles / App Notes
Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
Article
USP Stresses Pharmacopeial Standards at CPhI China
Keynote speakers included former FDA officials, USP experts, members of the Chinese Pharmacopoeia Commission, and senior pharmaceutical executives.
The seminar was designed to explain the latest q…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
In that instance between Sandoz and Amgen, Sandoz did not disclose its manufacturing processes and FDA application to Amgen, the patent holder for Neupogen (filgrastim). A California judge ruled, howe…
Article
Challenges and Trends in Biopharma Facility Design
Quality control and building standards are also essential, with a view to meeting [European Medicines Agency] EMA, FDA, [Chinese Food and Drug Administration] CFDA, and other regulatory standards for …
Article
Quality by Design—Bridging the Gap between Concept and Implementation
One of the speakers at the meeting, Christine Moore, acting director of FDA’s Office of New Drug Quality Assessment (ONDQA), summarized the main concerns as being the classifying of criticality, level…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
US FDA. Guidance for industry. Validation of chromatographic methods. Rockville, MD; 1994.
12. US FDA. Guidance for industry. Bioanalytical method validation for human studies. Rockville, MD; 1998…
Article
Advancing QbD in the EU
However, EMA has not been a strong driving force behind the adoption of QbD in the EU compared with FDA in the United States.
Recently, both EMA and the EC have experienced pressure from the…
Article
Address the complexity of protein characterization
Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant clinical success and have been used to provide effective treatment for a range of diseases. Durin…
Article
Getting your investigational drug regulatory ready
Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators…