Scientific Guidelines

Scientific guidelines (human and veterinary)
  1. ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
  2. Preliminary QIG Considerations regarding Pharmaceutical Process Models
  3. Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations
  4. Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline