![]() ![]() Labcorp Drug Development (Geneva Switzerland) He received a BSc in biology from Indiana University of Pennsylvania (PA, USA), a PhD in pharmacology from the University of Pittsburgh (PA, USA) and has over 100 peer-reviewed publications and podium presentations. He was co-chair of both the AAPS Crystal City V and VI Workshops, served as the 2018 PharSci360 Bioanalytics Track Chair, is Vice Chair for the 2020 PharmSci 360 Conference and is an AAPS Fellow. For 35 years, Mark has been involved in the field of bioanalysis, including the review and interpretation of regulations and guidance. and responsible for both immunochemistry and LC–MS capabilities, including outsourcing to partner CROs. Previously, Mark was Executive Director of the Bioanalytical Sciences Department at Bristol-Myers Squibb (NJ, USA). Mark Arnold collaboratively develops and delivers innovative scientific and regulatory strategy to meet current and future client needs – including ligand-binding, cell-based, qPCR and LC-MS/MS assays to quantify drugs and metabolites, antidrug antibodies and biomarkers to support PK/PD assessments. ![]() What do bioanalytical labs of the future look like with the ICH M10 guidance implemented in light of recent changes in the way drugs are being developed?.How does the ICH M10 affect bioanalytical outsourcing?.How might the ICH M10 affect individual regulatory bodies? What is the process for individual regulatory bodies to implement ICH M10?.What have been some significant hurdles in developing the ICH M10 guidance?.Why is there a need now for the ICH M10 guidance and for harmonization efforts?.Firstly, can you give a brief overview of the ICH M10, its history and where it is at currently?.Our panel of experts will provide insights as to what the draft ICH M10 guidance is, what it aims to achieve and its implications for bioanalytical laboratories around the world. Therefore, Summary Table 2 has been corrected to reflect a PDE of 6.2 mg/day and 620 ppm in the latest (and currently valid) version of the guideline, published here as ICH Q3C(R6).In this Ask the Experts feature, we ask experts from across pharma and CROs to share their thoughts and perspectives on the draft ICH M10 guidance. This information was evaluated by the EWG and the group concluded that the original PDE value listed in Summary Table 2 (6.2 mg/day 620 ppm) was appropriate and recommended reinstituting the PDE value for EG. However, while Summary Table 2 was revised to reflect the updated PDE, the Appendix 5 monograph was not. Based on archival documents and a review of the literature, it appears that the EG PDE of 6.2 mg/day was accepted at Step 4 of the Q3C guideline in 1997 following reassessment of the toxicity data. In 2019, ICH received a request to suspend the error correction for EG. This error correction was finalized in 2018 and published as ICH Q3C(R7). The EWG then recommended that Summary Table 2 of the guideline be revised to reflect the PDE indicated in the Appendix 5 monograph (3.1 mg/day). ![]() This issue was presented to the Q3C EWG for discussion and given the lack of any additional information or awareness of a supporting rationale for the value listed in Summary Table 2, the EWG considered the discrepancy to be a transcription error in the Summary Table 2. The PDE indicated in the monograph was 3.1 mg/day. In 2017, ICH was notified by an external party of a discrepancy between Summary Table 2 of the guideline and the monograph for EG listed in Appendix 5. ![]() Prior to 2017, the ICH Q3C Guideline Summary Table 2 listed ethylene glycol (EG) as a Class 2 residual solvent with a PDE of 6.2 mg/day. ![]()
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