Pharmacokinetics and Pharmacodynamics of Biosimilar Insulins: Is Clamp Technology Fit for Purpose?: Table 1
نویسندگان
چکیده
منابع مشابه
Pharmacokinetics and Pharmacodynamics of Biosimilar Insulins: Is Clamp Technology Fit for Purpose?
The euglycemic glucose clamp was first used to assess the new human insulins in the early 1980s by comparing pharmacodynamics (PD) of square-wave intravenous infusions in terms of the clamp glucose infusion rate (1). Shortly afterward, the technique was adapted to study the profile of action of subcutaneously injected insulin (2) and in people with type 1 diabetes rather than people without dia...
متن کاملHow to Accurately Establish Pharmacokinetics/Pharmacodynamics of Long-Acting Insulins in Humans: Relevance to Biosimilar Insulins.
In this issue of Diabetes Care, Linnebjerg et al. (1) compare the pharmacokinetics (PK) and pharmacodynamics (PD) of a Lilly synthetized insulin glargine (LY IGlar) with the insulin glargine Lantus (IGlar) based on a series of clamp studies in healthy volunteers and conclude for PK/PD that there is similarity of the LY IGlar vs. IGlar. The strengths of the study should be discussed along with i...
متن کاملBiosimilar insulins: how similar is similar?
Biosimilar insulins (BIs) are viewed as commercially attractive products by a number of companies. In order to obtain approval in the European Union or the United States, where there is not a single BI currently on the market, a manufacturer needs to demonstrate that a given BI has a safety and efficacy profile that is similar to that of the "original" insulin formulation that is already on the...
متن کاملThe Future of Biosimilar Insulins
IN BRIEF Biosimilar insulins are available in many countries and will be made available in the United States in the near future. Some concerns associated with biosimilar insulins include potential differences in the efficacy and safety between a biosimilar product and its reference insulin, the ramifications of having the same name or different names for a biosimilar and its reference insulin, ...
متن کاملBiosimilar insulins: a European perspective
Biosimilar insulins are likely to enter clinical practice in Europe in the near future. It is important that clinicians are familiar with and understand the concept of biosimilarity and how a biosimilar drug may differ from its reference product. The present article provides an overview of biosimilars, the European regulatory requirements for biosimilars and safety issues. It also summarizes th...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Diabetes Care
سال: 2015
ISSN: 0149-5992,1935-5548
DOI: 10.2337/dc15-1046