Clinical Biotherapeutics
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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.
- Pharmacokinetics of therapeutic proteins
- pharmacodynamics of therapeutic proteins
- Toxicology of therapeutic proteins
- Toxicology measures in therapeutic proteins
- Clinical development of therapeutic proteins
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Clinical Biotherapeutics Conference Speakers
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- Advancements in Biotherapeutics
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