{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled \"Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products.\" The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is an annex to an ICH guidance entitled \"Q1A(R) Stability Testing of New Drug Substances and Products\" (66 FR 56332, November 7, 2001). It is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in ICH Q1A(R).","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2003/01/16/03-904.html","cfr_references":[],"citation":"68 FR 2339","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The guidance is effective January 16, 2003. Submit written or electronic comments at any time.","disposition_notes":null,"docket_ids":["Docket No. 01D-0361"],"dockets":[],"document_number":"03-904","effective_on":"2003-01-16","end_page":2340,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/01/16/03-904.xml","html_url":"https://www.federalregister.gov/documents/2003/01/16/03-904/international-conference-on-harmonisation-guidance-on-q1d-bracketing-and-matrixing-designs-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-904?publication_date=2003-01-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-01-16/03-904/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":375,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-01-16/pdf/03-904.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-01-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/01/16/03-904.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2339,"subtype":null,"title":"International Conference on Harmonisation; Guidance on Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products; Availability","toc_doc":"Q1D bracketing and matrixing designs for stability testing of new drug substances and products","toc_subject":"Harmonisation International Conference; guidelines availability:","topics":[],"type":"Notice","volume":68}