a. Freeze and 668-672 Thaw Stability b. Bench-Top 674-677 Stability c. Long-Term Proposed change: This reads as though a 5 year clinical study would require 5 year LTS to be demonstrated. We recommend changing the wording to storage time in a long-term Stability “The 679-682 stability evaluation shall equal or exceed the duration from time of sample collection to analysis for any given sample”. d. Stock 684-690 Solution Stability e. Processed 692-695 Sample Stability C. Validated Method: Recommendation: It appears this section was cut/pasted from the chromatography section. Use, Data Analysis, Certain aspects of which do not apply to LBAs. Recommend deleting portions that don’t 697 and Reporting apply and expanding on LBA expectations.
668-672 a. Freeze and Thaw Stability 674-677 b. Bench-Top Stability 679-682 c. Long-Term Stability Proposed change: This reads as though a 5 year clinical study would require 5 year LTS to be demonstrated. We recommend changing the wording to “The storage time in a long-term stability evaluation shall equal or exceed the duration from time of sample collection to analysis for any given sample”. 684-690 d. Stock Solution Stability 692-695 e. Processed Sample Stability 697 C. Validated Method: Use, Data Analysis, and Reporting Recommendation: It appears this section was cut/pasted from the chromatography section. Certain aspects of which do not apply to LBAs. Recommend deleting portions that don’t apply and expanding on LBA expectations.
IQ_Comments_on_the_FDA_Draft_Guidance_for_Industry_Bioanalytical_Method_Validation.docx