Strategic IND enabling studies to align with regulatory expectations
Aragen supports biotech and pharma companies to help identify the right drug candidate by conducting exploratory tox studies during the late lead optimization stage.
Exploratory Studies for Candidate Nomination
Aragen supports designing exploratory studies on last 4-5 candidates to minimize risk of failure.
| Studies/Weeks | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
|---|---|---|---|---|---|---|---|---|
| DMPK | ||||||||
| In Vitro Metabolism (CYP inhibition, hepatocytes stability, microsomal stability, plasma stability, etc.) | ||||||||
| In Vitro Permeability (PAMPA, Caco -2, MDCK-MDR-1, etc.) | ||||||||
| Protein Binding | ||||||||
| In Vivo Rodent PK | ||||||||
| Toxicology | ||||||||
| mini-Ames | ||||||||
| mini-hERG | ||||||||
| MTD/Tolerability in Rodents | ||||||||
| 7 Days Rodent Toxicology with TK | ||||||||
| Drug candidate and backup nomination |
Our team of scientists and regulatory experts are ready to guide you through the most important journey of IND programs. From meticulous preparation to strategic planning, we ensure that your IND program aligns with regulatory expectations, accelerates timelines and optimized costs.
Nonclinical Safety Assessment of NCE - IND in 9 Months
| Studies/Weeks | 1-4 | 5-8 | 9-12 | 13-16 | 17-20 | 21-24 | 25-28 | 29-32 | 33-36 | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analytics | |||||||||||||||||||||||||||||||||||||||||||
| DF-method development & validation | 4 | ||||||||||||||||||||||||||||||||||||||||||
| BA method development & validation - Rat | 5 | ||||||||||||||||||||||||||||||||||||||||||
| BA method development & validation-Non-rodent | 5 | ||||||||||||||||||||||||||||||||||||||||||
| General Tox | |||||||||||||||||||||||||||||||||||||||||||
| MTD & 7-10 days repeat dose DRF with TK in Rat | 5 | ||||||||||||||||||||||||||||||||||||||||||
| MTD & 7-10 days repeat dose DRF with TK in Non-rodent | 8 | ||||||||||||||||||||||||||||||||||||||||||
| 4 Week in Rat with 2 or 4 Week recovery - Rat | 18 | ||||||||||||||||||||||||||||||||||||||||||
| 4 Week in Non-rodent with 2 or 4 Week recovery Non-rodent | 20 | ||||||||||||||||||||||||||||||||||||||||||
| Safety Pharmacology | |||||||||||||||||||||||||||||||||||||||||||
| CNS in Rat | 6 | ||||||||||||||||||||||||||||||||||||||||||
| RESP in Rat | 6 | ||||||||||||||||||||||||||||||||||||||||||
| HERG-patch clamp. | 4 | ||||||||||||||||||||||||||||||||||||||||||
| CVS - Dog telemetry | 10 | ||||||||||||||||||||||||||||||||||||||||||
| Mutagenicity | |||||||||||||||||||||||||||||||||||||||||||
| Ames test | 4 | ||||||||||||||||||||||||||||||||||||||||||
| In vitro CA or MNT | 8 | ||||||||||||||||||||||||||||||||||||||||||
- Species Selection - Metabolism as a primary factor (rodent and nonrodent)
- Dose Selection - Based on toxicity (maximum tolerated dose)
- Pivotal Toxicology - Required two species ranging from two weeks to three months
- Safety Pharmacology - Usually standalone studies
- Genetic Toxicology - Required
- Ref - Guideline as per FDA Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.
Timeline can be optimised upon understanding of molecule and regulatory pathway. Dossier writing support Module 2 and 4
BA - Bioanalysis, DF - Dose Formulation, MTD - Maximum Tolerated Dose, DRF - Dose Range Finding, CNS - Central Nervous System, RESP - Respiratory, CVS - Cardiovascular, CA - Chromosomal Aberration, MNT - Micronucleus
Nonclinical Safety Assessment of NBE – IND in 9 Months
| Studies/Weeks | 1-4 | 5-8 | 9-12 | 13-16 | 17-20 | 21-24 | 25-28 | 29-32 | 33-36 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BA method development-Rat | 4 | |||||||||||||||||||||||||||||||||||
| BA method validation - Rat | 6 | |||||||||||||||||||||||||||||||||||
| BA partial method validation - NHP | 8 | |||||||||||||||||||||||||||||||||||
| DF method development | 2 | |||||||||||||||||||||||||||||||||||
| DF method validation | 3 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method development in Rat | 8 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method validation in Rat | 8 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method development in NHP | 8 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method validation in NHP | 8 | |||||||||||||||||||||||||||||||||||
| Single dose & DRF in Rat* | 8 | |||||||||||||||||||||||||||||||||||
| Single dose & DRF in NHP* | 12 | |||||||||||||||||||||||||||||||||||
| 4 Week in Rat with 2 or 4 Week recovery - Rat | 18 | |||||||||||||||||||||||||||||||||||
| 4 Week in NHP with 2 or 4 Week recovery - NHP | 20 | |||||||||||||||||||||||||||||||||||
*Study duration based on PK
- Species Selection - Pharmacology as a primary factor; may be one or two species
- Dose Selection - Based on pharmacology or maximum feasible dose
- Pivotal Toxicology - One species up to six months in duration
- Safety Pharmacology - Part/all may be in toxicology studies
- Genetic Toxicology - May not be required
- Ref - Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals S6(R1).
Timeline can be optimised upon understanding of molecule and regulatory pathway. Dossier writing support Module 2 and 4
BA - Bioanalysis, DF - Dose Formulation, DRF - Dose Range Finding, NHP - Non-human Primate
