the diabetes pandemic: Responding to FDA Guidance on Cardiovascular Risk in Type 2 Diabetes Treatment

Diabetes is increasing at a disturbing rate both in the US and Europe, and in China. In America approximately 4000 people are diagnosed with type 2 diabetes each day. In recognition of this alarming growth and the ongoing research and development of both preventive and palliative diabetes treatment, in December, 2008 the FDA released guidance on new anti-diabetic drugs.

Read more

A ‘Mix and Measure’ Multiplexed assay to assess oxygen consumption and Microbial Metabolism

MitoXpress® is a water-soluble oxygen- sensitive phosphorescent probe that facilitates microtitre-plate based analysis of microbial oxygen consumption. The ‘mix and measure’ procedure allows rapid and specific detection of microbial oxygen consumption providing a simple yet sensitive means of assessing the impact of a given manipulation on cellular function.

Read more

Seeing Beyond the Visible With Near-infrared dyes

Optical imaging enables non-invasive study of molecular targets inside the body of the living animal. This technology can be used to follow the progression of disease, the effects of drug candidates on the target pathology, the pharmacokinetic behaviour of drug candidates, and the development of biomarkers indicative of disease and treatment outcomes.

Read more

Point of care testing – the New panacea?

The future demands on the Health Service are going to be partly dictated by demographic change and partly by resources available, including money (current funding for the NHS from Central Government is £98 billion per annum). With more people living longer and requiring healthcare, the pressure on the Health Service is steadily increasing.

Read more

Basic Biostats for Clinical Research Multiple Comparisons in Drug Development, Part II

Multiplicity can have a significant impact on clinical trials, in the study design, the analysis of the data, and the interpretation of the results. It can show up in several ways:
1. Multiple comparisons among the treatment groups;
2. Comparisons of different endpoints;
3. Comparisons of endpoints at different
time points;
4. Interim analyses;
5. At the programme level.
The first three concepts were discussed in Part I of this series1. This paper covers the remaining two concepts.

Read more

Developing Innovative Cancer Medicines of the Future via Patient-Relevant Models

There is currently a high attrition rate for new cancer drugs which enter into clinical trials, due to pre-clinical models not accurately predicting efficacy and/ or toxicity. In a recent study provided by Cancer Research UK, it was shown that between 1995 and 2007, 77% of 800 cancer drugs entering Phase I clinical trials failed to reach the market

Read more

How to Measure Sustainability of Pharmaceutical Packaging

This article by Dr Manfred Zurkirch of Dividella AG presents a method to measure the environmental impact of different products or services in an analytical way. The LCA method enables the customer to rank packaging solutions and to choose those that help him to reduce his ecological footprint. In general, this environmental ranking goes hand in hand with the economic ranking. In other words, sustainable packaging solutions also save substantial money and can help improve the bottom line of pharmaceutical manufacturers.

Read more

Ensuring the Safety and Authenticity of Pharmaceutical Drugs with Innovative Packaging Technologies

The World Health Organization (WHO) currently estimates the global trade in counterfeit drugs to be worth £75 billion, with continued growth predicted to be at a staggering rate of 13% a year. As the counterfeit trade grows, criminals are becoming increasingly sophisticated and capable in the way they package their products. Richard Burhouse of Payne Security explains the global regulatory bodies that have introduced strict legislation to ensure maximum security of pharmaceutical packaging.

Read more