Search results for " pharmacokinetics" in Articles / App Notes
Article
Ligand-Binding Assays and the Determination of Biosimilarity
…al characteristics of the biosimilar, it is necessary to demonstrate that the pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of the biosimilar are also comparable to those of the br…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
As the molecule progresses through development and more is learned about the relationship between product attributes and their impact (or non-impact) on potency, pharmacokinetics (PK), or safety, thes…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
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…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
After purification these small fragments are usually modified to improve their pharmacokinetics using technologies, such as PEGylation. PEGylation dramatically changes the chromatographic properties o…
Article
Quality by design for biotechnology products—part 1
…tography (IEC), and online mass spectrometry to quantify the level of deamidation
preclinical pharmacokinetics studies with the native and deamidated molecules
in vivo potency studies w…