| Topics |
Factors |
Content |
| Product related |
Intrinsic |
Product profile, sequence homology |
| Extrinsic |
Process related impurities, Aggregates, Degradation Products, Stability of active ingredients in DP formulation |
| Immunogenicity related clinical risks |
|
Cross-reactive Abs, Drug hypersensitivity responses, Abrogation of efficacy due to neutralizing Abs or quick clearance |
| Analytical Methods |
|
Rationale for choice of methods, PK assay, ADA assay, assessment of cross reactive potential, neutralizing Ab assay etc. |
| Nonclinical |
|
Overview , ADA vs PK/PD, and Other toxicities |
|
Clinical |
Studies contributing to immunogenicity, ADA responses, ADA vs PK/PD, ADA vs efficacy |
| Impact of immunogenicity on overall assessment of benefit and risk |
| Recommendations for risk management plan |
|
