Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development
نویسندگان
چکیده
منابع مشابه
development and implementation of an optimized control strategy for induction machine in an electric vehicle
in the area of automotive engineering there is a tendency to more electrification of power train. in this work control of an induction machine for the application of electric vehicle is investigated. through the changing operating point of the machine, adapting the rotor magnetization current seems to be useful to increase the machines efficiency. in the literature there are many approaches wh...
15 صفحه اولdevelopment of feminist poetics in adrienne rich
اشعار ریچ، به عنوان اشعاری که همیشه در حال تغییر و دگرگونی هستند، تجسمی از رشد و دگرگونیِ انسان هستد. پایان نامه ی حاضر، با تمرکز بر روی مراحل سیر شعری ریچ از تغییری در دنیا به عکس هایی فوری از یک عروس، سپس به شیرجه به درون کشتی شکسته و در نهایت به صبری عجیب مرا تا اینجا آورده، به بررسی این مراحل در قالب نظر شوالتر در رابطه با سه مرحله ی پیشرفت ادبی زنان یعنی مرحله ی زنانه، زن گرا و زن محور می پ...
15 صفحه اولStatistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation.
Children represent a large underserved population of "therapeutic orphans," as an estimated 80% of children are treated off-label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that...
متن کاملDrug Development for Pediatric Populations: Regulatory Aspects
Pediatric aspects are nowadays integrated early in the development process of a new drug. The stronger enforcement to obtain pediatric information by the regulatory agencies in recent years resulted in an increased number of trials in children. Specific guidelines and requirements from, in particular, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) form the regula...
متن کاملPediatric Melanoma and Drug Development
Importance-Pediatric melanoma occurs, albeit rarely. Should patients be treated by today's medical standards, or be subjected to medically unnecessary clinical studies? Observations-We identified international, industry-sponsored pediatric melanoma studies triggered by regulatory demands in www.clinicaltrials.gov and further pediatric melanoma studies demanded by European Union pediatric invest...
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: The Journal of Clinical Pharmacology
سال: 2016
ISSN: 0091-2700
DOI: 10.1002/jcph.744