Preclinical Development of Pharmaceuticals

• Designing and executing preclinical programmes for clinical development and recommending the appropriate studies under consideration of existing data to meet the respective ICH test guidelines (including range finder and bridging studies as required).
  
  
• Advising on study designs including selection of vehicle (if necessary) and dose levels based on existing data as well as the type of atmosphere, e.g. dry powder vs. solution vs. MDI.
  
  
• Recommending CRO facility based on quality, experience, measures to avoid cross-contamination, timing, capacity and price.
  
  
• Monitoring of studies from CRO quality audit, through protocol development, practical atmosphere generation and monitoring up to report review.
  
  
• Preparation of CTD tables.

Benefits

• Ensuring a high quality standard of the performed studies with valid atmosphere data and the avoidance of cross-contamination resulting in study reports being acceptable by the respective authorities.
  → Meet planned schedule for the submission of application dossiers to authorities.
  
  
• Proposal of appropriate and tailor-made testing strategies and study designs in a ‘fit-for-purpose’ approach under consideration of selection of vehicle, type of atmosphere (e.g. dry powder vs. solution vs. MDI) and possible bridging studies.
  → Selecting only relevant options and study designs for an efficient use of resources.
  
  
• Advising on selection of appropriate dose levels, enabling to get the best data for the test compound (maximizing safety factors).
  → Defining an optimal low NOAEL (no observed adverse effect level) is maximizing the probability for a favourable risk-benefit-ratio and economic advantages against the competitor(s).
  
  
• Taking over administrative work including scheduling as required.
  → Saving time and internal costs/resources.

Collaboration with other specialists, consultants, laboratories as appropriate to the project.