february, 2017

27feb11:30 am1:30 pmFeaturedDeveloping a robust 14C preclinical and clinical study strategy: a simple plan to deliver a complex program of studies


Event Details

Presentation by Quotient Clinical & Pharmaron

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Date: 27 February, 2017

Venue: Catalyst Restaurant, 300 Technology Square, Cambridge, MA

Time: 11:30am – 1:30pm (including lunch)

Presentation titles and summary

Join our free lunch seminar to hear case studies describing the building blocks of a human ADME program and best practices for regulatory submissions.

In addition, this presentation covers possible non clinical ADME combinations and potential drug-drug interactions (DDI) arising from the clinical metabolite analysis. Several case studies highlight how the results from the human ADME study generate additional metabolism investigations in justification of metabolite safety.

Presentation 1: A complicated program made easy – simplifying the human ADME program

Iain Shaw, Director 14C Enabled Drug Development, Quotient Clinical

  • The building blocks of a human ADME study for regulatory submission
  • The Synthesis to Clinic approach to program integration
  • How a single study can deliver complete pharmacokinetic and metabolism knowledge
  • Case history examples

Presentation 2: The implications of metabolism

Ray Cooke, Director, Business Development, Pharmaron

  • Non clinical ADME: Before, During & After
  • What are the DDI implications?
  • Recent case history examples of what happens after the human ADME study


(Monday) 11:30 am - 1:30 pm


Catalyst Restaurant

300 Technology Square, Cambridge, MA 02139