Apr 13,2015
Filing an Investigational New Drug (IND) Application is the first step towards beginning clinical trials. An appropriately designed package of studies; conducted with the right controls, appropriate statistical tests and accurately documented results are paramount for successful filing. ASKbreakthrough can help with various aspects of your preclinical package from reviewing study plans to ensuring results are reported correctly. We can review or develop documentation based on your needs.
Our Preclinical Documentation Service includes:
You have a lead compound and are in the process of undertaking preclinical toxicity studies. However, the study design must conform to OECD Guidelines for obtaining regulatory approval. We will design your study plan based on your requirement and ensure it meets OECD Guidelines
You have already designed your study, but want to confirm that your study plan meets OECD Guideline requirements. We can review the study plan in detail and recommend modifications according to OECD requirements.
We will review your preclinical toxicology study report for clarity, internal consistency and flow.
Our documentation design and review expertise cover the following types of studies and will comply with OECD Test Guidance:
| Study Type | Toxicity Study |
|---|---|
| IND Filing Support Studies | |
| Repeat Dose | Dose-range-finding: Rodent |
| Maximum Tolerated Dose: Non-rodent | |
| Dose-range-finding: Non-rodent | |
| 28-day Repeat Dose: Rodent + Non-rodent | |
| Safety Pharmacology | In vitro hERG Assay |
| Cardiovascular Study: Non-rodent | |
| Neuropharmacology Study: Rodent | |
| Pulmonary Study: Rodent | |
| Genotoxicity | Bacterial Reverse Mutation (Ames) Test |
| In vitro Chromosome Aberration Test | |
| In vivo Micronucleus Test | |
| Phase II Support Studies | |
| Repeat Dose | 90-day Repeat Dose: Rodent + Non-rodent |
| Development and Reproductive Toxicity (DART) | Segment I : Rat |
| Segment II: Rat + Rabbit | |
| Male Fertility | |
| Phase III Support Studies | |
| Repeat Dose | 9-month Repeat Dose: Rodent + Non-rodent |
| DART | Segment III: Rat (Need to confirm only one species is needed) |
| Dose-range-finding: Mice | |
| Carcinogenicity: Mice + Rat | |
