Have you Considered Microsampling for your ANDA Submission?
Have you seen the recent FDA guidance confirming the possibility of using microsampling for PK sampling in ANDA trials? Please refer to Section 3c, page 11 of the guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
Altasciences’ leadership and expertise in the field of microsampling is unparalleled, including preclinical collection, clinical collection and self-sampling, and bioanalytical method development using a variety of microsampling techniques and devices.
You may also be interested in the following:
- The Altascientist Scientific Journal: Microsampling
- Fact Sheet: Microsampling in Early Phase Drug Development
- Blog: Leveraging the Benefits of Microsampling for Safety and Convenience
- Video (two minutes): Microsampling
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept.