AIDD works internally with various post-discovery and development teams within Aragen to provide the full range of IND-enabling studies and services to the partner to enable them to formulate a comprehensive IND submission package to the FDA. The following tabulated information provides some readily useful information to all our partners. The full package depends on the nature of program and the therapeutic indication desired. AIDD collaborates with external partners for studies and services that are not available internally within Aragen.
| S. No. | Type of Activity | Estimated Duration (approx.) | Remarks |
|---|---|---|---|
| 1 | IND Enabling DMPK Studies (Non-GLP): In-vitro: CaCO2 permeability/Efflux, in-vitro transporter assays incl. P-gp, PPB (m/r/d/mo/h), Blood cell partitioning, Hep. Stab., Cyp Inhibition (human microsomes/hep.), Cyp-TDI, Met ID, Thermodynamic Solubility In-vivo: IV/PO PK in rats, dogs, Tissue distribution |
In-vitro: 1-2 months In-vivo: 2 wks-1 month |
|
| 2 | Non-GLP In-vivo Tox studies: Formulation analysis (r/d), DRF Studies (MTD) (r/d) | 5-6 months | |
| 3 | Candidate Nomination: Initial Compound Assessment, Solid-State Characterization, Phase-appropriate Salt & polymorph screening, Preclinical formulation (oral BA enhancement), In-use stability, Recipe for reg tox studies | 2-3 months | DS required: 25-50 g of non-GMP material |
| 4 | ~ 2 kg API Manufacturing (GMP)/CMC | 3-3.5 months | Timeline includes raw material contribution and its lead time. Assumption of 6 steps of moderate complexity is made. |
| 5 | GLP Tox studies: 4-week repeated dose tox (TK) studies (r/d), hERG, CVS Jacketed Dog telemetry, Rat CNS study, Rat respiratory study, Ames & in-vitro MNT | 6-8 months | |
| 6 | IND Filing: Clinical DP strategy (DIB, DIC, Tablet, Capsule, micronisation/spray drying), Clinical formulation development prototypes (2 bracketed strengths, oral solids), Analytical method dev, ICH stability on lab scale/engineering batch, Phase-appropriate analytical methods & cleaning validation, Clinical DP mfg and release, ICH stability on clinical batch, Shipment of clinical DP to clinical site location | 4.5-6 months | DS required: 1.75 Kg, considering 100 mg max dose and 10000 units for clinical trials (GMP) |
| 7 | Optional IND dossier writing – Module 2.4 and 2.6; SEND (Instem platform) report conversion |
