- E&L Study
- E&L case study
- USP 1663
- USP 1664
- USP 1664.1
- ICH Q3E
- Medical Device
<1664.1> ORALLY INHALED AND NASAL DRUG PRODUCTS
In addition to the key terms listed in <1664>, some additional key terms more specific to OINDP are the following:
- Critical components are packaging components that contact either the drug product formulation or the patient, or that affect the mechanics of the overall performance of the packaging and delivery system, including any necessary secondary packaging. The identification of critical components for a particular OINDP dosage form is the responsibility of the applicant in consultation with appropriate regulatory authorities.
- Special case compounds are individual (or classes of) compounds that have special safety or historical concerns as drug product leachables in OINDP, and therefore must be evaluated and controlled as leachables (and extractables) by specific analytical techniques and technology-defined thresholds.
Additional terminology and associated definitions specific to OINDP are available in the cited references (1–5).