Type 1 Diabetes (T1D) Special Statutory Funding Program
Access to Research Resources:
Pre-clinical development of therapeutic agents
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Pre-clinical development of therapeutic agents
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Type 1 Diabetes-Rapid Access to Intervention Development (T1D-RAID)
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Please visit the T1D-RAID website for information on submitting requests to the T1D-RAID program. The following resources are available to the scientific community:
- 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);
- Scale-up production from lab-scale to clinical-trials lot scale;
- Development of suitable formulations;
- Development of analytical methods for bulk substances;
- Production of dosage forms;
- Stability assurance of dosage forms;
- Range-finding initial toxicology;
- IND-directed toxicology, with correlative pharmacology and histopathology;
- Planning of clinical trials;
- Regulatory affairs, so that FDA requirements are likely to be satisfied by participating investigators seeking to test new molecular entities in the clinic;
- IND filing advice.
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