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外审完后判定大修，各位帮我看看，有希望吗 Comments: Dear Dr. Xueying, Thank you for submitting your manuscript to J. Chrom. B. Based on the received referee report I request a major revision of your manuscript. There are notably important parameters of your study that should be clarified according to current regulatory guidelines. Please address all comments and submit a revised version of your study for further review. Sincerely yours, Rainer Bischoff Editor in Chief Reviewer #1: The article is interesting and revision is required in improving the method development and validation as per USFDA JULY 2015 recommendation for method validation of drugs and biologic. Please find the queries as enlisted (i) Method robustness needs to be evaluated and discussed in method development (ii) Comparative and contrasting model of bio-distribution has not been cited . A reference model is required to be incorporated so that the study findings are anchored to the extant knowledge domain (iii) Need to provide statistical methods to confirm matrix effect in different lots have no impact on method. Statistical support as per USFDA JULY 2015 recommendation for method validation of drugs and biologic clearly states for such confirmatory analysis. (iv) Figures with T-joint to show there is no ion suppression or enhancement at the retention time of analyte is important and should be essentially discussed. (v) Metabolites monitoring needs to be discussed. (vi) Discussion on using ESI mode of mass spectrometry, employing liquid -liquid chromatography and reason for selecting Inertsil ®ODS3 C18 column for separation has not been clarified. (vii) Syntax errror and English usage needs to be improved throughout the paper. (viii) Authors should argue the potential of being a high-throughput method due to achieving separation from both endogenous and exogenous interfering compounds. (ix) Quality of method should be discussion with clarity against the reported literature. (x) However, considering the merit of the research highlights, the article has a potential to fit in short communication category after revision. Though the article couldn't be accepted in current form, it is suggested that authors work on the major points as discussed above and resubmit for consideration. Once again, thanking you for contributing in bio-distribution field and best wishes for your future endeavors. |
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