Lhasa Limited shared knowledge shared progress
Publications
  • Publisher:
    American Pharmaceutical Review
  • Publication Date:
    Mar 2016
  • Reference:
  • DOI:
  • PMID:
  • Publication Type:
    Other
  • Related Products:
  • Scientific Area:
  • Endpoint:
  • Industry Type:
  • Related event:

Impact from the Recent Issuance of ANVISA Resolution RDC-53/2015 on Pharmaceutical Small Molecule Forced Degradation Study Requirements

Tattersall P; Asawasiripong S; Takenaka I; Castoro JA;

This paper, published in American Pharmaceutical Review, discusses the recent RDC-53/2015 regulation. 

Forced degradation studies (FDS) are essential in the development of stability indicating methods to gain understanding of the intrinsic stability characteristics of a Drug Substance (DS). Guidance on forced degradation used by industry comes via formal documents from ICH, FDA, and publications/reviews on the topic. Recently, ANVISA published the RDC53/2015 regulation outlining specific requirements with regard to reporting, identification and qualification of degradation products. The extension of FDS requirements necessitated a review and update of current accepted practices, and assessment of its impact to previously filed and registered products to ensure compliance. The forced degradation requirements are discussed herein in relation to study design, reports and interpretation of such requirements. 

Visit site

© 2018 Lhasa Limited | Registered office: Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK Tel: +44 (0)113 394 6020
VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

Thanks to QuestionPro's generosity, we now have survey software that powers our data intelligence.