Clinical pharmacology studies play a crucial role in understanding how a drug behaves in the human body and in supporting regulatory submissions. In this webinar, Neha Bhise, Ph.D., discusses key clinical pharmacology studies that help inform drug labeling and filing packages during drug development.
These studies help evaluate a drug’s pharmacokinetics (PK), pharmacodynamics (PD), safety, and dosing strategy, providing essential insights for regulatory filings and prescribing information. They also support decisions related to drug interactions, bioavailability, organ impairment, and other factors critical to successful development.
Organizations developing new therapies often rely on expert partners to design and execute these studies efficiently. Services such as clinical pharmacology, drug development strategy & regulatory support, and model-informed drug development play an important role in ensuring that the right data is generated for regulatory submissions.
Explore with Neha Bhise, Ph.D. the clinical pharmacology studies that are critical to inform labeling and filing packages, their significance on drug development, as well as other various aspects, such as: first-in-human, food effect studies, bioavailability studies, and more.
What You Will Learn
- The role of clinical pharmacology studies in drug development
- Key study types such as first-in-human, bioavailability, food effect, and drug-drug interaction studies
- How these studies inform drug labeling and regulatory filing packages
- Considerations for evaluating organ impairment, QT prolongation, and safety profiles
Learn more about Allucent’s clinical pharmacology expertise here.
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