Search results for " efficacy" in Articles / App Notes
Article
EMA Collaborates with HTA Assessment Networks
First a drug has to be approved for its quality, safety, and efficacy by one or more regulatory authorities. This approval can be either by the central London-based European Medicines Agency (EMA) for…
Article
Brazil Emerges as Global Biopharm Collaborator
Brazil is also controlling the efficacy and safety of pharmaceutical products through market regulation.
According to Guimarães, considering government expenditures with health products, biophar…
Article
Climate Change in Outsourcing
…pt (POC) model, which calls for minimizing development efforts until there is evidence of safety and efficacy in human subjects. POC is leading to specialization in the CMC (chemistry, manufacturing,…
Article
Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
Precision is so crucial that even small variations in the manufacturing process can potentially alter the medicine’s safety and efficacy (7). It takes significant expertise and experience to ensure a …
Article
QbD and PAT in Upstream and Downstream Processing
For mAbs, besides the afore-mentioned factors, concentration of critical nutrients has been known to affect the glycoxylation pattern of the product, thereby impacting product efficacy.
Vanden Boo…