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Under the MICROSCOPE

13 June 2013 | By Katherine Bakeev, Director of Applications Support, B&W Tek

We talk to Katherine Bakeev, Director of Applications Support, B&W Tek. B&W Tek is a leading supplier of handheld Raman spectroscopy, a recognised method for compliance with the PIC/S GMP guide to provide 100 per cent assurance of the identity of pharmaceutical materials. Katherine Bakeev, Director of Applications Support at…

Current activities of the USP Microbiology Expert Committee

18 April 2013 | By Radhakrishna S. Tirumalai

For sterile as well as nonsterile pharmaceutical products, manufacturers must eliminate or minimise potential risks to patients as well as product quality. While many contributing factors may affect the quality of a medicine or its ingredients, microbial contamination control and proper sterilisation methods are critical considerations for the manufacturer throughout…

microRNA: Small RNA molecules of great utility as diagnostic biomarkers in lung cancer

18 April 2013 | By Michela A. Denti and Margherita Grasso, Laboratory of RNA Biology and Biotechnology, Centre for Integrative Biology, University of Trento, Mattia Barbareschi and Chiara Cantaloni, Unit of Surgical Pathology, Santa Chiara Hospital

In 1993, the laboratories of Victor Ambros and Gary Ruvkun, studying the larval development of the nematode Caenorhabditis elegans, found a small RNA molecule (22 nucleotides) which regulated the translation of the lin-14 gene in an unusual way1,2. They observed that the sequence of the tiny lin-4 RNA was complementary…

A pragmatic approach for the adoption of QbD principles for analytical method development and validation

18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG

The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…

The role of proteomics in the development of personalised cancer medicine

18 April 2013 | By Pedro R. Cutillas, MRC Clinical Sciences Centre, Imperial College London

Not all cancer patients, even those with the same tumour type, respond to therapy equally well. An understanding of this heterogeneity at the molecular level is crucial for further advances in the development of cancer therapies. Discerning the mechanisms of cancer heterogeneity will lead to a better selection of the…

The central role of excipients in drug formulation

18 April 2013 | By Pascal Furrer, Pharmacist

Active substances are rarely administered alone. For example, levothyroxine, a synthetic form of the thyroid hormone, indicated in the treatment of hypothyroidism, is administered at a very low dosage, ranging from 15 μg to 200 μg. These very small amounts of powder mean that it is not possible to manufacture…

Gene to drugs: can expression be the key to new discoveries?

25 February 2013 | By Esther P. Black, College of Pharmacy and Markey Cancer Center, University of Kentucky

Cancer treatment faces a conundrum: a growing lack of therapeutics with lasting effects. The low hanging fruit of the medicinal chemistry orchard seems to have been picked, and modification of existing anti-cancer therapeutics has produced only incremental rewards[1]. Thus, both pharmaceutical companies and academic researchers are left searching for new…

Industry Expert Panel

21 February 2013 | By

Welcome to European Pharmaceutical Review’s Industry Expert Panel. We have assembled a panel of authoritative voices from the pharmaceutical industry to speak on a wide range of issues that affect this industry, sharing their expertise and insight with our readers.

Applications of solid-state NMR spectroscopy to pharmaceuticals

21 February 2013 | By Eric Munson, Patrick DeLuca Endowed Professor in Pharmaceutical Technology, Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky

Solid-state NMR spectroscopy (SSNMR) has emerged as an extremely powerful analytical technique for the characterisation of pharmaceuticals[1-5]. Despite its capability, SSNMR is still not used ubiquitously in the pharmaceutical industry. Several factors contribute to this, including cost and analysis time, but two of the major reasons are understanding the full…