On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”. This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency. As is no surprise, FDA clearly re-iterates throughout the document that the protection of study participants’ health and welfare are essential, consistent with decades-old requirement well before COVID-19 surfaced.
This guidance provides recommendations in four (4) key areas:
- Safety of study participants with consideration for i) participant eligibility; ii) modifying study visits; and iii) alternative sampling;
- Need for site plans or an SOP describing how to reduce risk of exposure to COVID-19, not only for study participants but also for staff conducting the BE study;
- Assuring scientific validity of the study focusing on i) protocol development and amendments; ii) deviations; iii) oversight of the study; and iv) expiration of the test and/or reference drug; and
- Planning for starting or resuming BE studies.
This guidance document has a little bit for everyone involved in BE studies regardless of whether you are a sponsor, a CRO conducting the clinical and/or bioanalytical portion of the BE study, or PK scientists analyzing the data. As stated several times within the document, don’t forget to follow applicable local and national guidelines and requirements in reducing the spread of COVID-19. From all of us at Lachman Consultants, stay safe and stay healthy! The guidance can be found here.