Search results with tag "Small molecule"
Essential IND Strategies: Fundamental Considerations on ...
health.ucdavis.edudrug formulations, with well characterized impurity profiles. 5) ... Does not address potential genotoxic impurities in API Genetic Toxicology . Requirements ICH Core Battery: ... Small molecule – commonly stand alone studies Biological – …
2 Small Molecule Activation - ICCC2018
www.iccc2018.jp1 Session Name Yoshiaki Nishibayashi Japan University of Tokyo Hiroyuki Kawaguchi Japan Tokyo Institute of Technology Michael Fryzuk …
Jan Ouwerkerk Research Coördinator Oncologie …
www.oncowijs.nlTrifluradine & tipiracil (LONSURF) ® • Monoclonal antibody of een small molecule? Geen van beide = cytostatische therapie • Orale …
All About Regulatory Affairs - Granzer
www.granzer.bizChoice of procedure When do we have a choice of procedure for a generic medicinal product? – When the originator product was approved centrally • New pharmaceutical forms with new features are no generics – When it is a classical small molecule • Independent of indication! – When it fulfils the eligibility criteria for the centralized …