Clinical Trails & Biotherapeutics

Clinical Biotherapeutic aspects including study 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.

Clinical Biotherapeutic aspects including study 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.

  • Clinical Trials in Developing Countries
  • Pharmacovigilance and Drug Safety
  • Clinical Nursing Research
  • Biomedical Devices Clinical Research
  • Stem Cell & Oncology Clinical Research
  • Innovations in Pre-clinical Research
  • Design of Clinical Studies and Trials
  • Clinical Research and Trials on AIDS
  • Clinical Trials on Different Diseases
  • Drug Abuse
  • Diabetes & Gastroenterology Clinical Research
  • Transforming Trial Methodologies
  • Innovations in Clinical Trials
  • Cancer Biotherapeutics
  • Clinical Biotherapeutics
  • Structural Analysis of Small Organic Molecules
  • Peptide Therapeutics

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