Clinical Trails & Biotherapeutics

Clinical Biotherapeutic aspects including study 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 Biotherapeutics. 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.

  • Discovery & Preclinical Testing
  • Clinical Study Designs
  • Alternative Trials Design & Models
  • Data Collection & Quality Control
  • Advanced Information Technology in Clinical trials
  • Clinical Trial Protocol
  • Recent Technology in Biopharmaceuticals

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