Final answer:
When the manufacturer of an IND already has an active IND for the drug being studied, they can cross-reference clinical trial protocols, manufacturing process details, and pharmacokinetic properties.
Step-by-step explanation:
When the manufacturer of an Investigational New Drug (IND) already has an active IND for the drug being studied, there are several aspects that can be cross-referenced.
- Clinical trial protocols: The manufacturer can compare the protocols of the two INDs to see if there are any differences in the study design, patient population, or endpoints being assessed.
- Manufacturing process: The manufacturer can review the details of the manufacturing process documented in the active IND to ensure consistency and quality in the production of the drug being studied.
- Pharmacokinetic properties: The manufacturer can assess the pharmacokinetic properties of the active IND to understand how the drug is absorbed, distributed, metabolized, and eliminated in the body.