Publications by authors named "Julia Berik"
J Pharm Sci
February 2020
Article Synopsis
- Pharmacopeial quality standards help ensure the quality of medicines and may also promote innovation and competition in pharmaceutical markets, particularly in the generic drug sector.
- A survey of generic drug manufacturers in the US and India indicates that using these standards can reduce development time by up to 31% and lessen the risk of Abbreviated New Drug Application (ANDA) rejection by the FDA.
- While the survey results are promising, they are based on a small sample size, so they should be interpreted cautiously for understanding broader trends in the industry.
