Asia Becoming Important Phase I Player (Asia)
This article was originally published in PharmAsia News
Executive Summary
Global pharmaceutical companies are increasingly conducting clinical trial development from the basics upward in Asia, rather than simply using Asia's outsourcing industry for late-stage clinical work. As a result phase-I clinical trials are becoming more prevalent in China, South Korea, Japan, and India, alongside late-stage trials more often underway in these developing countries. Shirley Suresh of Singapore Clinical Research says that comparing global data from full-spectrum clinical trials is more scientifically effective than comparing data from "bridging studies." The U.S.-based FDA concurs, notes Suresh. Suresh says that Singapore has been encouraging companies to develop research from the phase-I level, and has been attracting international attention. Singapore also has a mixed Asia population, and so its clinical trial data is being accepted in South Korea, in some cases in Japan, and by other countries, says Suresh. Japan's recent lowering of regulatory hurdles to clinical trials should boost the volume of global companies conducting clinical research in Japan in 2008 and 2009. (Click here for more
You may also be interested in...
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.
Lilly Can Rest Easy As Tirzepatide Scores Phase III Sleep Apnea Win
Topline results from two studies in obstructive sleep apnea among obese adults showed efficacy crossing the 50% threshold that physicians have called clinically meaningful.