Pre-Clinical & IND

Nuventra services that may be utilized in the pre-clinical and IND phase include:

  • Toxicokinetic analyses and reporting
    • Nuventra has the ability to perform GLP TK analyses using a validated PK/PD software, including QA review and sign-off.
  • Assistance with designing in vitro/ in vivo transporter and DDI studies
  • Nonclinical vendor identification and management
  • First-time-in-human (FTIH) protocol
  • Clinical Pharmacology Plan
  • IND authoring
    • Full IND Authoring including all CTD modules
    • Targeted authoring of PK and TK sections of the IND (for example, Sections 2.6 and 2.7)
  • FDA Briefing Packet preparation (e.g. for pre-IND meeting)

 

Pre-clinical Model-Based Drug Development (MBDD)

The overall goal of MDBB is to illuminate drug development strategies and improve decision-making within clinical development programs. Learn more.

Using mathematical and statistical methods, we build models of drug concentration (pharmacokinetic) and/or drug response (pharmacodynamic) over a time course (PK/PD), which can play a critical role throughout the drug development process.

  • Drug Candidate Selection (Pre-IND):  A model-based approach can utilize available in vitro and/or in vivo data to predict the pharmacokinetic profile of a drug in humans prior to the first human exposure.  These early predictions can be a key component in the rationale for selecting the first dose to administer to humans.  Specifically, doses can be selected which are predicted to provide an acceptable safety margin relative to exposures achieved in non-clinical toxicology studies.