Issues about Current "Guidelines for Non-Clinical Pharmacokinetic Studies".
نویسندگان
چکیده
منابع مشابه
Predictive data mining in clinical medicine: Current issues and guidelines
BACKGROUND The widespread availability of new computational methods and tools for data analysis and predictive modeling requires medical informatics researchers and practitioners to systematically select the most appropriate strategy to cope with clinical prediction problems. In particular, the collection of methods known as 'data mining' offers methodological and technical solutions to deal wi...
متن کاملCurrent issues in clinical trial design: superiority versus equivalency studies.
HISTORICALLY, the gold standard for drug approval by positive for the human immunodeficiency virus were the US Food and Drug Administration (FDA) has been randomized to the placebo group at a time when it was convincing evidence of efficacy in double-blind, placeknown that azidothymidine (AZT) prevented fetal trans bo-controlled, clinical trials. Because a placebo-conmission of the virus. On Fe...
متن کاملGuidelines for pharmacokinetic and pharmacodynamic studies in early phase clinical trials
Introduction The Pharmacodynamic/ pharmacokinetic Technologies Advisory Committee (PTAC) of Cancer Research UK has the objective of increasing the extent of mechanistic and hypothesis testing in early phase clinical trials. PTAC reviews all applications submitted to the New Agents Committee (NAC) and with expertise in PET, MRI and MRS as well as many of the other currently emerging technologies...
متن کاملClinical Pharmacokinetic Studies of Enzalutamide
BACKGROUND AND OBJECTIVES Oral enzalutamide (160 mg once daily) is approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This article describes the pharmacokinetics of enzalutamide and its active metabolite N-desmethyl enzalutamide. METHODS Results are reported from five clinical studies. RESULTS In a dose-escalation study (n = 140), enzalutamide half-life w...
متن کاملExecuting clinical guidelines: temporal issues
In our previous work, we proposed a domain-independent language to describe clinical guidelines and a graphical tool to acquire them. In this paper, we describe an approach to execute clinical guidelines. We propose a flexible execution engine that can be used in clinical decision support applications, and also for medical education, or for integrating guidelines into the clinical workflow. We ...
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: Drug Metabolism and Pharmacokinetics
سال: 1997
ISSN: 0916-1139
DOI: 10.2133/dmpk.12.217