Phase 0 approaches—which include microdosing—evaluate subtherapeutic exposures of
new drugs in first-in-human studies known as exploratory clinical trials. Recent progress …

A long-lived radioisotope of iodine, 129 I, is a fission product and is released into our
environment by spent nuclear fuel reprocessing plants or nuclear accidents. The …

ABSTRACT Introduction: Phase-0 studies, including microdosing, also called Exploratory
Investigational New Drug (eIND) or exploratory clinical trials, are a regulatory framework for …

Preclinical development of new biological entities (NBEs), such as human protein
therapeutics, requires considerable expenditure of time and costs. Poor prediction of …

The concept of microdosing has been around for more than a decade. It consists of the
subpharmacologic administration of an investigational drug (1% of the pharmacologic dose …

The concept of precision medicine has entered broad public consciousness, spurred by a
string of targeted drug approvals, highlighted by the availability of personal gene …

Poor pharmacokinetics (PK) can seriously limit clinical utility. Knowing early whether a new
compound is likely to have the desired PK profile at therapeutic doses is therefore important …

Introducción: La eritropoyetina (EPO) es una glicoproteína que actúa como regulador
principal de los glóbulos rojos en los seres humanos y se produce en los riñones. Se ha …

There is an urgent need to accelerate the development of new drugs to treat unmet medical
needs both in the developed and underdeveloped parts of the world. There is also an urgent …

Drug attrition that occurs in late clinical development or during postmarketing is a serious
economic problem in the pharmaceutical industry. 1 The cost of drug approvals is …