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The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
On Oct. 19, 2016, the International Council for Harmonization (ICH) announced two new guidelines and gave an update on ICH E11(R1). One guideline, ICH M10, will address validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. The other guideline, ICH M9, will discuss biopharmaceutics classification system (BCS)-based biowaivers.
ICH’s concept paper, dated Oct. 7, 2016 states that ICH M10 Guideline in Development on Bioanalytical Method Validation “will apply to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies … provides recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs of both chemical and biological origins.”
ICH M10 will define validation characteristics, their appropriate evaluation method, and acceptance criteria; clarify cases that require partial or cross validation; establish requirements for reference standard and critical reagents; and consolidate scientific experience and progress of instrumentation/technology. Requirements for ensuring validity of analytical runs, clarifying conditions for reanalysis, and establishing required percentage of samples to be tested for incurred samples reanalysis (ISR) and its acceptance criteria will also be addressed.
The council’s concept paper on ICH M9 states, “Although the scientific data that can be used to support BCS-based biowaivers is the same, it seems that interpretation of these data differs. Harmonisation will create a common understanding of the applicability of BCS-based biowaivers and the conditions of waiving, which in addition can be used also outside ICH countries developing and/or introducing BCS-based biowaivers.
The guideline will address supportive data for classification, including solubility and permeability; supportive data for a waiver; the establishment of conditions for dissolution testing; and clarify if a BCS-based biowaver is only applicable for pharmaceutical equivalents.
ICH also gave an update on its draft addendum guideline, ICH E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population. The guideline, which addresses new scientific and technical knowledge advances in pediatric drug development, has reached Step 2b of the ICH process and has entered the consultation period.