Role of public standards in the safety and efficacy of biologic medicines.

Autor: Williams RL; United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852, USA., Bristow AF, Hauck WW, Srinivasan VS, Morris T, Atouf F, Ambrose M, Surendranath KV, Chakrabarty R, Menon K
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2014 May; Vol. 16 (3), pp. 516-21. Date of Electronic Publication: 2014 Apr 02.
DOI: 10.1208/s12248-014-9586-7
Abstrakt: In this report, we emphasize the importance of public monographs with reference materials, coupled with careful process and change control and attention to GMPs, as a means of advancing access to good quality, safe, and effective medicines, with emphasis on available and incoming biologic medicines. With adequate control of articles covered by a monograph, these public standards can form the basis for a global public quality platform that covers reference products, non-interchangeable reference products, biosimilars, and interchangeable biosimilars. Working collaboratively with all stakeholders, new approaches allow these public standards to emerge nationally and globally in a timely way. Yet, there are increasing limitations in the availability of public standards for biologic medicines, which may reverse many decades of progress. Solutions are considered in this report.
Databáze: MEDLINE
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