Example: biology
Formulation development testing and approval
Found 3 free book(s)
Q8(R2) - ICH
www.ich.orgQ8(R2) Document History First Codification History Date Parent Guideline: Pharmaceutical Development Q8 Approval of the Guideline by …
An Analysis of the US Biosimilars Development …
www.biopharma.com16 BioProcess International 11(6)s Ju n e 2013 Supplement N o consensus concerning biosimilar-related terminology and definitions has yet been achieved (1–3).Biosimilars may be defined as biopharmaceuticals slated for generic-
Dissolution Testing for Poorly Soluble Drugs: A …
www.dissolutiontech.comDissolution Technologies | AUGUST 2010 25 Sink is sink condition calculated as C S /CD (where C D is the concentration of compound in the bulk medium) and should be greater than or equal to 3.