Search results - 16 results
Pyrogen testing of phage therapeutic products
this work, we discuss and compare the applicability of the LAL, rFC and MAT tests for pyrogen testing of clinical grade phage products based on the analysis of various productions manufactured by the ...
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
regulatory or advisory bodies. This document is intended to discuss fundamental principles of selection, characterization, manufacture, quality control and storage of challenge agents for international ...
Panel discussion official forum Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release procedures
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release ...
Panel discussion on CMC in 'Risk- based strategies to support current health emergency
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: World Vaccine Conference (EU), Terrapinn, Web based (2020) Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medic ...
Panel discussion on IABS Webinar on CHIM and COVID19
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: SARS CoV-2 CHIM Webinar, Issue IABS (2020) Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories ...
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).
and adaptive studies). Pairwise comparisons were also discussed during the workshop; however, mostly for historical reasons. This paper discusses the added value and limitations of these methods as well ...
Innate signaling by mycobacterial cell wall components and relevance for development of adjuvants for subunit vaccines.
adjuvants inducing cell-mediated immune responses. Their potential use as lipid antigens in novel tuberculosis subunit vaccines is also discussed. Expert commentary: Few adjuvants are licensed for human use ...
Chemometrics and the identification of counterfeit medicines-A review.
of actual case studies dealing with verifying the authenticity of selected medicines supported by different chemometric approaches. In particular, a general data processing workflow is discussed with ...
Panel discussion on quality by design
PDA Europe, Issue PDA Europe, Berlin, Germany (2015) Keywords: challenge CHALLENGES conference Countries Design developing Developing Countries Discussion Europe ON Quality vaccine vaccines WHO Health ...
Regulatory panel discussion. An interactive panel discussion with key authoritative figures from various European regulatory agencies focusing on the regulation of the biologics industry.
Affect an challenge CHALLENGES Discussion European Industries Industry ON production regulation Regulatory use Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten ...