There are several types of Reproducibility: between lab, re-injection, incurred sample, 1081-1082 between instrument, etc. Recommendation: that a more generic definition be provided or concisely define each type of reproducibility. Recommendation: define selectivity and specificity separately for LBA in line 1084. 1084-1086 Recommendation: change to in line 1089. “chemical” “biochemical” 1089-1090 IX. APPENDIX Recommendation: Use of hyperlinks for eCTD submissions sounds good but is fraught 1100-1103 Priority with issues in practice. The process needs someone with a full overview of study/program to manage submission/report/data links.
1081-1082 There are several types of Reproducibility: between lab, re-injection, incurred sample, between instrument, etc. Recommendation: that a more generic definition be provided or concisely define each type of reproducibility. 1084-1086 Recommendation: define selectivity and specificity separately for LBA in line 1084. 1089-1090 Recommendation: change “chemical” to “biochemical” in line 1089. 1100-1103 IX. APPENDIX Priority Recommendation: Use of hyperlinks for eCTD submissions sounds good but is fraught with issues in practice. The process needs someone with a full overview of study/program to manage submission/report/data links.
IQ_Comments_on_the_FDA_Draft_Guidance_for_Industry_Bioanalytical_Method_Validation.docx