Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies misconceptions enable faster, safer, more cost-effective biosimilars. This paper proposes a platform for model guideline based on scientific evaluation of regulatory filings 130+ products approved in US, UK, EU hundreds WHO member countries. Extensive literature survey clinical data published rep...

Credit risk as the board in banks basically centers around deciding probability of a customer's default or credit decay and how expensive it will end up being assuming happens. It is important to consider major factors predict beforehand consumers defaulting given their conditions. Which where machine learning model comes handy allows financial institutions whether customer, they are giving loa...

BACKGROUND The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies-Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)-and to explore differences in the drug approval processes that might contribute to any disparities. METHODS T...

Approval voting is designed to be "insensitive to numbers" of voters, and likely to elect a Condorcet candidate. However, the result of an election among one group of candidates gives no information about the results of elections among any other groups, even if every voter follows the recommended utilitymaximizing strategy, which places strong restrictions on the individual voter's subset ballo...

CLINICAL PHARMACOLOGY Absorption After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of Tindamax tablets was conducted in adult healthy volunteers. All subjects received a single oral dose of 2 g (four 500 mg tablets) of tinidazole following an overnight fast. Oral administration of four 500 mg tablets of Tindamax under fasted conditions produced a ...

We present a formal model of political competition under approval voting which allows for endogenous candidate entry. Our analysis yields a number of novel insights. First, we develop a notion of sincere voting behavior under approval voting, called relative sincerity. We then show that the relatively sincere voting behavior is consistent with the strategic calculus of voting. Second, we show t...

We examine the phenomenon of “pockets of teenage illegitimacy” in a model of social approval, where attitudes to such illegitimacy are endogenously determined at a local community level. Both a woman’s actual well-being and her community’s perception of that well-being in each potential state − staying in school and early childbearing − impact her decisions. In particular, since individuals can...