Analytical Method Development. The following analytical method development activities are proposed. Method development covers laboratory activities intended to define the method. Authoring of method development reports and validation activities are separate and not included in the estimates given here. Identification method Uses current HPLC method, mix 1:1 sample with reference material, show that only one peak elutes from HPLC. Update method document. [*] hours Aggregation method Develop size exclusion chromatography method to characterize any formation of aggregates in drug product [*] hours Release Method Explore and develop method for release testing of microneedle patches. [*] hours Pouch Integrity Adapt ASTM method to microneedle patches [*] hours Patch Adhesion Adapt ASTM method to microneedle patches [*] hours * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Workplan #4 FDA RESPONSE WORK PLAN SUMMARY Objective: Respond to FDA’s questions regarding 3M’s manufacturing process and controls. Scope:
Appears in 4 contracts
Samples: Development and Clinical Supplies Agreement (Radius Health, Inc.), Radius Health, Inc., Radius Health, Inc.
