article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This presents an obvious financial benefit in the form of cost savings and helps guarantee the safety and reliability of the final product.

article thumbnail

Inflationary storm clouds will continue to buffet global pharma industry in 2023

Pharmaceutical Technology

The legislation contains several provisions to lower prescription drug costs, including allowing Medicare to negotiate the cost of selected medicines. A worst-case scenario could also involve some pharmaceutical production in China being diverted to domestic use in early 2023.

Pharma 64
article thumbnail

Inflationary storm clouds will continue to buffet global pharma industry in 2023

Pharmaceutical Technology

The legislation contains several provisions to lower prescription drug costs, including allowing Medicare to negotiate the cost of selected medicines. A worst-case scenario could also involve some pharmaceutical production in China being diverted to domestic use in early 2023.

Pharma 52