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Research

TRND Resources

cellular image of Niemann-Pick type C diseaseExamples of resources that TRND can provide for discovery projects include but are not limited to:

  • Medicinal chemistry optimization.
  • Evaluation of functional activity, potency, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy.
  • Biomarker development.
  • Definition or optimization of dose and schedule for in vivo activity.
  • Development of pharmacology assays.
  • Conduct of pharmacology studies with a pre-determined assay.
  • Acquisition of bulk substance (GMP and non-GMP).
  • Development of suitable formulations.
  • Development of analytical methods for bulk substances.
  • Production of dosage forms.
  • Stability assurance of dosage forms.
  • Range-finding initial toxicity.
  • Investigational New Drug (IND)-directed toxicology, with correlative pharmacology and histopathology.
  • Planning of clinical trials.
  • Regulatory support, so that FDA requirements are likely to be satisfied by participating investigators seeking to test new molecular entities in the clinic.
  • IND filing support.