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Our team has an average of 10+ years of oncology […]
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Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA) and 5th GCC (14 November 2011, Barcelona, Spain) Closed Forums. These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.
The 2nd Global CRO Council (GCC) for Bioanalysis Closed Forum was held on 15 April, 2011 in Montreal, Canada. In attendance were 45 senior-level representatives from 39 CROs on behalf of eight countries.
The topic of Incurred Sample Stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the 7th Annual Workshop on Recent Issues of Bioanalysis (WRIB) held in Long Beach, California, USA, in April 2013, and at the Global CRO Council (GCC) meeting preceding it.
An Open Letter written by the GCC describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings lead to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past two years.
Microdosing has been used as an investigative pharmacokinetic tool for approximately 10 years. Initial skepticism of the value of these studies was followed by investigative clinical trials to understand the circumstances when they provide useful data and this has led to routine use. When first introduced, accelerator mass spectrometry coupled with LC fractionation (LC+AMS) was the only technology that could provide the sensitivity required for these studies. Over the years, LC-MS/MS sensitivity has improved so that it is now viable to use this technique for microdosing studies, and a decision needs to be made on what technique to use.
Traditionally, absolute bioavailability ( has been determined using a crossover study design, requiring administration of an IV dose expected to give plasma concentrations similar to those arising from the therapeutic extravascular (EV) dose. An alternative approach is to administer an isotopically labelled IV microtracer dose concomitantly with the EV dose (see Figure 1 This methodology is both scientifically superior and more resource efficient With the inclusion of ABA data mandatory for marketing applications submitted to the Australian TGA 1 and other regulators increasingly asking for this information, a growing number of such studies are being conducted
Arachidonic acid metabolites are biologically active lipid molecules that regulate many functions and play critical roles in a variety of physiological and pathophysiological processes. Some of the eicosanoids are used as a potential biomarkers related to inflammation, immune reactions and side-effects of drugs. Eicosanoids are derived from arachidonic acid and then from other metabolites by enzymatic and non-enzymatic reactions and have very similar structure and physical properties. Pattern of intermediates and final eicosanoids production is determined in a stimulus and cell-specific fashion. Fast and simultaneous qualitative and quantitative profiling of eicosanoids (lipidomics) in biological samples is possible because of high sensitivity and selectivity of liquid chromatography/mass spectrometry methods and simplicity of sample preparation.
5-Fluorouracil (5-FU) is well-known anti-cancer drug,widely used for decades against a variety of solid tumors. 5 -Fluorouracil has a narrow therapeutic index, there is a very little difference between the theoretical minimum effective dose and the maximum tolerated dose, and therefore it needs to be administrated intravenously to control therapeutic dosage.
A sample treatment procedure and high-sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for quantitative determination of nicardipine in human plasma were developed for a microdose clinical trail with nicardipine, a non-radioisotope labeled drug.
The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before the start of the 6th Workshop on Recent Issues in Bioanalysis.
The importance of appropriate sample management in regulated bioanalysis is undeniable for clinical and non-clinical study support due to the fact that if the samples are compromised at any stage prior to analysis, the study results may be affected. Health authority regulations do not contain specific guidance on sample management; therefore, as part of the Global Bioanalysis Consortium (GBC), the A5 team was established to discuss sample management requirements and to put forward recommendations.
In recent years, the large molecule drug development market continues to lead the way with double digit growth, driven by various factors such as increase in elderly population, surge in prevalence of chronic diseases such as cancer and diabetes, and the rise in strategic collaborations and funding in the biopharmaceutical industry. Alongside large molecule drug development, oligonucleotide therapeutics is also emerging as an established and validated class of drugs that can modulate a multitude of genetic targets. Since 2016, five oligonucleotides have been approved to treat a range of diseases.
The clinical development phase continues to represent the most challenging stage of drug development globally, critical to the successful commercialization of new products but posing multiple and complex considerations in terms of trial design, enrollment and outcomes. Failure can prove costly and even critical to the survival of smaller companies heavily reliant on relatively few pipeline assets.
The contract research organization (CRO) market in the Asia-Pacific (APAC) region is the fastest- growing in the world, with revenue expected to increase at a 20% compound annual growth rate (CAGR) from 2016 to 2021 compared with the rest of the world’s 11.4% CAGR.
There is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. With a more receptive climate for both starting and running trials, an improved infrastructure for clinical research, and significant advances in accelerating drug approvals, Japan is now firmly on the global development map.
Contract manufacturers are right at the center of the transformation that is reshaping the pharmaceutical and biotech industry. Their central position brings opportunities and challenges that keep them striving to stay on top of quality, technological innovation and safety and regulatory considerations. The flip side of this is working strategically to ensure the right business decisions are made, managing costs and astutely investing in technology.
Since its introduction in the 1980s, the market of orally disintegrating tablet (ODT) has grown annually and ODTs are now available in a variety of therapeutic areas, both over-the-counter (OTC) and by prescription. ODT market is projected to reach US$21B in 2023. In this webinar, CMIC and Aprecia experts talked about advanced ODT technologies and its advantages in drug development.
The webinar was presented by experts in CMIC Group, focusing on tips and insights for early phase oncology drug development in Asia: the market trend, development strategy, regulatory requirements and a case study with step-by-step planning to ensure clinical trial success.
The webinar focused on an overview of the Japanese pharmaceutical market, its unique characteristics, regulatory updates and market entry options. Through a case study, our industry experts provided step-by-step guidance on what to look out for and to how to ensure a successful market entry.
