Examples 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.