Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies

التفاصيل البيبلوغرافية
العنوان: Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies
المؤلفون: Cherokee Hoaglund-Hyzer, Mingkun Fu, Alexander Abbott, Megan McMahon, Sylvine Pischel, Lori McCaig, Chi-wan Chen, Jenny Carhart, Kayla Woodlief, Andrew Lennard, Dennis Stephens, Yan Wu, Debra Webb, Fenghe Qiu, Robert J. Timpano, Hanlin Li, Tony Mazzeo, Elke Debie, Yelizaveta Babayan, Chad Nolan Wolfe
المصدر: The AAPS Journal. 23
بيانات النشر: Springer Science and Business Media LLC, 2021.
سنة النشر: 2021
مصطلحات موضوعية: Technology, Discussion group, business.industry, Computer science, International Cooperation, media_common.quotation_subject, Pharmacology toxicology, Stability (learning theory), Pharmaceutical Science, Guidelines as Topic, Risk Assessment, Drug Stability, Pharmaceutical Preparations, Risk analysis (engineering), New product development, Humans, Current technology, Quality (business), Risk assessment, business, Drug Approval, media_common
الوصف: In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Science- and Risk-based Stability Working Group conducted a comprehensive review of ICH Q1A, Q1B, Q1C, Q1D, Q1E, and Q5C to identify areas where the guidelines could be clarified, updated, and amended to reflect the potential knowledge gained from current risk-based predictive stability tools and to consider other science- and risk-based stability strategies in accordance with ICH Q8-12. The recommendations propose a holistic approach to stability understanding, utilizing historical data, prior knowledge, modeling, and a risk assessment process to expand the concept of what could be included (or would be acceptable) in the core stability data package, including type and amount of stability evidence, assignment of retest period and shelf-life for a new product, and assessment of the impact of post-approval changes.
تدمد: 1550-7416
DOI: 10.1208/s12248-021-00641-6
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::731bc556aaab25ec8ed805c05e69f648
https://doi.org/10.1208/s12248-021-00641-6
Rights: CLOSED
رقم الانضمام: edsair.doi.dedup.....731bc556aaab25ec8ed805c05e69f648
قاعدة البيانات: OpenAIRE
الوصف
تدمد:15507416
DOI:10.1208/s12248-021-00641-6