Nanomedicine and Drug Delivery

Clinical Trails & Bio therapeutics

Clinical Bio therapeutic aspects including study drug formulations, drug design, drug-drug interactions, QT assessment, immunogenicity, comparability, special populations (hepatic and liver failure), PK and PD, regulatory expectations of PK and PD characterization, as well as reviewing factors which influence the ADME of Bio therapeutics. The objectives of early clinical development of therapeutic proteins are the same as for small molecules i.e. to investigate the molecule in a manner that will gain necessary knowledge about its tolerability safety pharmacokinetics (PK) and if possible pharmacodynamics (PD) effects in the most appropriate human populations while simultaneously protecting their safety. However, there are specific features of proteins that must be considered when designing clinical pharmacology studies.