505(b)(2): It’s A Different Animal
Camargo
Hot Topics > Clinical evolution
Clinical evolution
Randomised clinical trials have been the mainstay of pharmaceutical product development for decades, but will they be designed and carried out the same way in future? With trials tipped to get smaller and patient selection more complex as pharma’s blockbuster model is dismantled, interactive technologies, adaptive designs and new ways to recruit and monitor patients will come to the fore.
New data adds weight to case for microdosing
24-Jun-2008 - Newly-released data appears to add weight to the case for microdosing as a means to more accurately predict pharmacological dose absorption, metabolism, distribution and elimination (ADME) and pharmacokinetic (PK) outcomes...
eClinical potential explored
05-Dec-2007 - As eClinical gathers momentum, Outsourcing-Pharma.com spoke to two contract research organisations (CROs), Icon and Parexel, to get their views on the present and future of these emerging technologies.
Industry bodies call for EU clinical trials directive changes
18-Oct-2007 - Two major bioscience industry trade associations have called for changes to be made to the European clinical trials directive in order to bring about "harmonisation, transparency and consistency" in this...
Weekly comment
UK tightens Phase I guidelines
21-Aug-2007 - The Association of the British Pharmaceutical Industry (ABPI) has now published revised guidelines for Phase I trials in the UK.
Adaptive trials are heating up
05-Jul-2007 - Adaptive trials were a hot topic at this year's Drug Information Association (DIA) Annual Meeting, held in Atlanta. The first of a free seminar series on the subject will also...
New simulator touts adaptive trial savings
15-Mar-2007 - In anticipation of a new wave of adaptive clinical trials, UK firm Tessella has designed a software system to help pharma firms conduct seamless trials that could ultimately save time...
Outourcing-Pharma focus on: FDA clinical trial initiatives
FDA signals new clinical trials flexibility
20-Jul-2006 - The US Food and Drug Administration (FDA) has signalled it will soon allow a new "adaptive" approach to clinical trials in order to streamline drug testing and speed drugs to...
Outsourcing-Pharma focus on: cutting the cost of clinical trials
Balancing the clinical scales
28-Mar-2006 - As pharma companies flock towards Eastern Europe and India in a bid to cut direct clinical trial costs, does outsourcing actually translate into real world cost-savings?
