Titlebook: Biosimilars; Regulatory, Clinical Hiten J. Gutka,Harry Yang,Shefali Kakar Book 2018 American Association of Pharmaceutical Scientists 2018

日月等

書目名稱Biosimilars影響因子(影響力)




書目名稱Biosimilars影響因子(影響力)學(xué)科排名




書目名稱Biosimilars網(wǎng)絡(luò)公開度




書目名稱Biosimilars網(wǎng)絡(luò)公開度學(xué)科排名




書目名稱Biosimilars被引頻次




書目名稱Biosimilars被引頻次學(xué)科排名




書目名稱Biosimilars年度引用




書目名稱Biosimilars年度引用學(xué)科排名




書目名稱Biosimilars讀者反饋




書目名稱Biosimilars讀者反饋學(xué)科排名

嚴(yán)厲譴責(zé)

STERN

描述

Lethargic

EXCEL

Learning Chinese in a Multilingual Spacent. The biosimilar drug product development strategy has to take additional multiple factors into consideration including matching the reference product presentation, intellectual property and the current state of the art in science and technology. This chapter reviews these factors in detail using case-studies from currently approved biosimilars.

pester

講個(gè)故事逗他

Design and Implementation of Successful Regulatory Strategies in Biosimilar Developmental they are required to undergo head to head similarity exercises [CMC, nonclinical and clinical (as~needed)] against their reference product already marketed in the region/country of interest or countries with stringent regulatory requirements.

inspiration

Drug Product Considerations for Biosimilarsnt. The biosimilar drug product development strategy has to take additional multiple factors into consideration including matching the reference product presentation, intellectual property and the current state of the art in science and technology. This chapter reviews these factors in detail using case-studies from currently approved biosimilars.

洞察力