Naslov
BEW Workshops - Past, Present and Beyond in Scientific Approaches in Bioequivalence, Bioanalysis, Dissolution and Biosimilarity

Autori
Jadrijević-Mladar Takač, Milena

Vrsta, podvrsta i kategorija rada
Poglavlja u knjigama, ostalo

Knjiga
History of Hungarian Bioequivalence Workshops

Urednik/ci
Klebovich, Imre

Izdavač
Medicina

Grad
Budimpešta

Godina
2014

Raspon stranica
475-478

ISBN
978 963 226 5155

Ključne riječi
BEW Workshops, scientific approaches, regulatory approaches, bioequivalence, biosimilarity

Sažetak
The use of generic drugs has the potential to reduce annual consumer spending on prescriptions by billions, therefore a major attempt for lowering cost of medication in many countries is introduction of generic equivalents of brand-name drugs (innovator drugs) and the bioequivalence (BE) is a strategy to introduce these drugs through proper assessment as directed by the international regulatory authorities who also started developing and formulating regulatory requirements for approval of generic drug products. Using BE as the basis for approving generic drugs was established by the Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman Act). From that period bioequivalence has been considered as one of the key questions in new and generic drug product development and registration worldwide. Subsequently various criteria and approaches for conducting and reporting BE studies for generic products from various regulatory authorities have been progressing and is still in progress. Although the scientific basis for BE is globally the same, it is obvious that the regulations and jurisdictions still differ to certain extent from country to country worldwide. Every country now has its own individual regulatory authority as well as regulatory guidance for bioavailability/bioequivalence (BA/BE) studies, and the magnitude of assessment of BE of drug product is influenced by the regulatory environment of the respective country of marketing. Differences arising from such circumstances create problems in registering of medicines, what influences the need for harmonization existing guidance at national level with those proposed by international regulatory authorities as well as the harmonization between guidances of world's regulatory leaders.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

POVEZANOST RADA