By David Jones2024-01-05T00:05:00
The ICH S6 guideline (Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals states: “Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or combinations of these substances, or may be living entities such as cells and tissues”.
Register to continue to access industry news, podcasts and commentary plus one member-only journal article each month. You will still be able to view editorials and contents pages without restriction.
Already a TOPRA member?
Using your MyTOPRA credentials, log-in now for unlimited access to all Regulatory Rapporteur journal articles, online archive and the latest industry news and content.
LoginBecome a TOPRA member and join our global regulatory affairs community.
The peer-reviewed journal, published 11 times per year and available free to TOPRA members.
The Organisation for Professionals in Regulatory Affairs
TOPRA office
TOPRA Publishing, 6th Floor, 3 Harbour Exchange, South Quay, London E14 9GE, UK
Tel: +44 (0) 20 7510 2560
Email: publications@topra.org
TOPRA AISBL
Blvd du Souverain 280, 1160 Brussels, Belgium
Tel: +32 (0) 2 808 72 70
Site powered by Webvision Cloud