Core Services

Together with you, I will find solutions when you meet challenges, have limited human resources or need a second opinion.

 

  NON-CLINICAL SAFETY PLANS

 

  • Design of non-clinical safety plans for NCEs and NBEs at all stages:
    • Early toxicology exploration
    • First human dose and enabling clinical trials
    • Phase II and III supporting non.clinical packages
    • Pivotal studies for Marketing Applications
  • Considerations of target biology, formulation, dosing regimen in clinical trials, etc.
  • Animal species qualification strategy for safety studies
  • In vitro and in vivo safety models
  • General and genetic toxicology studies
  • Safety pharmacology studies
  • Expert knowledge in reproductive, developmental and

juvenile toxicology study conduct and evaluation

  • Carcinogenicity studies
  • Non-clinical input to Paediatric Plans (PIPs)
  • Support to due diligences

 

  REGULATORY and SCIENTIFIC DOCUMENTS

 

  • Writing and review of non-clinical sections for CTD Module 2,

INDs, IBs, preIND packages, DSUR/PSUR, PIPs, Marketing Applications (BLA/NDA)

  • Non-clinical Risk Profiles
    • Safety evaluation prior to Clinical Trial Applications
    • Scientific strategy for internal company communication
  • Writing of scientific publications for internationally peer

reviewed journals

 

  STUDY CONDUCT and CRO OUTSOURCING

 

  • CRO study placement, if desired quotes from

several CROs can be requested 

  • Sponsor´s Monitor role:
    • Detailed study design
    • Protocol writing
    • Dose setting
    • In life monitoring
    • Report review and finalisation
  • Interpretation of results
  • Overall toxicological evaluation and risk assessment

 

 

  EDUCATIONAL SESSIONS

 

  • The Role of Non-clinical Safety within the

Drug Development Value Chain

  • Toxicology
  • Species and strain selection
  • Dose setting
  • NOAEL
  • Guideline requirements
  • Reproductive developmental assessment
  • Juvenile toxicology studies

Your benefits will be clear decision-making and confidence in the next steps of your

drug development program

Ingrid Brück Bøgh      *      Mobile: +45 5383 6655      *      Email: ingrid@ibbconsulting.dk        

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