Pharmaquest - White Papers

White Papers

Determining the Preclinical Toxicokinetic Comparability for a Biosimilar Drug

White Papers
Monday, 06 February 2012
Programs for biosimilar drugs usually need at least one preclinical study to support the clinical phase of development. This study must have pharmacokinetic, immunogenicity and toxicological components and provide insight into the similarities and differences (i.e., comparability) between the biosimilar and the innovator drug.
Read more...