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Articles

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

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
The role of proteomics in the development of personalised cancer medicine

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…

tablets
tablets

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.

Molecules
Molecules

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…

Extracellular microRNA: the promises for the diagnostics of multiple diseases

21 February 2013 | By Andrey Turchinovich and Barbara Burwinkel, German Cancer Research Center

This mini-review aims to summarise recent advances in the field of molecular diagnostic of diseases using extracellular circulating miRNA in biological fluids. We will also discuss obstacles in developing miRNAs as circulating biomarkers as well as the potential future of the field.

Getting to grips with drug resistance in the human protein kinase superfamily
Getting to grips with drug resistance in the human protein kinase superfamily

Getting to grips with drug resistance in the human protein kinase superfamily

21 February 2013 | By Patrick A Eyers, Department of Oncology, Sheffield Cancer Research Centre, University of Sheffield

Protein kinases represent a vast, partially untapped resource of drug targets for therapeutic intervention in human disease. The remarkable success of the tyrosine kinase inhibitor Imatinib, which is now the first-line therapy in Philadelphia-positive tyrosine kinase inhibitor Imatinibhas galvanised biomedical researchers in an attempt to repeat the landmark success of…

Fast quantitative 2D NMR for quantifying analytes in complex mixtures
Fast quantitative 2D NMR for quantifying analytes in complex mixtures

Improving the quantitation of live antigens used to produce rabbit generated serotype specific antiserum

21 February 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC, Silvia Fragoeiro, Ananthi Ramachandran and Paul van Empel MSD Animal Health

This is the first paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. Flow cytometry represents one of a variety of viability-based RMM technologies that are currently available to the pharmaceutical industry. In flow cytometry, individual particles are counted as…

Practical Workshop – Biochemical Assays for Screening

21 February 2013 | By Sheraz Gul, Head of Biology at European ScreeningPort, Hamburg, Germany

Recent years have witnessed an expansion in the disciplines encompassing drug discovery outside the pharmaceutical industry. This is most notable with a significant number of universities worldwide that now host infrastructure such as compound libraries and automated screening centres[1-3]. An archetypal small molecule drug discovery project will aim to identify…