Dose Selection Using Preclinical PK Modelling And In Vivo Studies




Date: Tuesday, November 28, 2017

Time: 11am ET (New York) / 4pm GMT (UK)

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Integrating PK modelling and in vivo studies for improved formulation and dosage form development - The main goal of formulation and dosage form development is to modify the pharmacokinetics of drugs to improve efficacy and safety. This goal is achieved through various means such as improving solubility and bioavailability and targeting drug release at a specific rate or at a specific site in the gut. This webinar will introduce the audience to pre-clinical tools used in the industry to study pharmacokinetics and how they are used to guide the development of new chemical entities (NCEs).

In silico physiological based pharmacokinetic (PBPK) modelling is the gold standard for predicting the absorption, metabolism, distribution, and elimination (ADME) properties for NCEs. With minimal in vitro data, PBPK modelling can reveal likely ADME challenges that can be addressed prior to in vivo studies, thereby saving time and costs. The addition of high quality in vivo data allows even better predictions by PBPK models. The webinar will also present the benefits of characterizing animals to improve translation to human and how non-invasive imaging approaches can provide valuable insights and add value to PBPK predictive models.

Learning Objectives:

  • List common pharmacokinetic challenges faced by new chemical entities
  • Explain the insights provided by in silico PBPK modelling
  • Understand ADME deficiencies that can be improved through formulation and dosage form
  • Appreciate the value provided by imaging tools during pre-clinical in vivo studies

Integrating PK modelling and in vivo studies for improved formulation and dosage form development