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Analysing the monographs

22 August 2005 | By Erwin Adams, Ann Van Schepdael and Jos Hoogmartens, Laboratory for Pharmaceutical Chemistry and Drug Analysis, Catholic University of Leuven, Belgium

The European Pharmacopoeia (Ph. Eur.)1 monographs are subject to regular adaptation in order to cope with progressing quality requirements. This contribution outlines the evolution in analytical requirements and techniques in monographs for organic substances. These monographs generally carry the subheadings definition, characters, identification, tests, assay and impurities.

The AstraZeneca ACMF

22 August 2005 | By Dr Dalin Nie, Associate Director, and Deborah S. Hartman, Director, Lead Discovery, AstraZeneca Pharmaceuticals, Wilmington

Compound management is an emerging discipline that represents a core component of the drug discovery process, from early phases involving high throughput screening (HTS) to late-stage lead optimisation screening cascades.

Taking care of innovation

22 August 2005 | By Thomas Keller, MPhil, PhD, Head of Applied Technology Group UK, European & International Operations, GlaxoSmithKline R&D

The most important factors for ensuring a successful future are innovation and an effective governance structure. Within this model1 in the pharmaceutical industry, the introduction of new technology is one of the key factors. This provides an organisation with efficient and reliable systems to facilitate the incorporation of new scientific…

Support for lead optimisation and target validation

22 August 2005 | By Stefan Prechtl, Group Leader, High Content Analysis and Philip Denner, Schering AG

High-Content Analysis (HCA) provides a drug discovery tool capable of rapid screening of drug effects in pharmacologically relevant cell culture systems. Interest in HCA has been increasing during the past few years. This reflects the confidence that HCA-technology has established due to the stability and reliability offered to the drug…

The road ahead and how to get there

22 August 2005 | By James Herrington and Owen B. McManus, Department of Ion Channels, Laszlo Kiss, Pain Research, Merck Research Laboratories

Ion channels are membrane spanning proteins with narrow hydrophilic pores that support the passive flux of inorganic ions across the cell membrane.

The rise of Raman

22 August 2005 | By Marleen de Veij, Dr. Peter Vandenabeele and Prof. Dr. Luc Moens, Laboratory of Analytical Chemistry, Ghent University

Traditionally, analyses in pharmaceutical research and industry were often performed using Nuclear Magnetic Resonance (NMR) or Mass Spectrometry (MS). However, researchers are aware that Raman Spectroscopy possesses advantageous characteristics for the pharmaceutical world.

A Pfizer perspective

22 August 2005 | By Joep Timmermans, Ph.D., Senior Manager/Team Leader, Process Analytical Support Group – Americas Implementation Team, Pfizer Global Manufacturing

While the current attention and focus on Process Analytical Technologies (PAT) may make you believe otherwise, PAT measurement systems have been used in the pharmaceutical industry, Pfizer included, for some time, albeit often to a limited extent.

International standards: a tool for compliance

22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting

Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.

More than just cost cutting

22 August 2005 | By Michel Philippart, Director, Sourcing & Procurement, GlaxoSmithKline Biologicals s.a.

In today’s challenging environment, aggressive cost control has become a common theme in the pharmaceutical industry.

The current challenge

22 August 2005 | By Professor Naomi E. Chayen, Biological Structure and Function Section, Division of Biomedical Sciences, Imperial College London

We are currently living in an exciting age, where for the fist time ever, human diseases are being understood at a molecular level. Protein crystallography plays a major role in this understanding because proteins, being the major machinery of living things, are often the targets for drugs.

Efficient HTS in the nanoliter range

22 August 2005 | By Dr Johannes Ottl, Laboratory Head, Novartis Pharmaceuticals

The pharmaceutical industry continues to face an ever-changing, increasingly competitive business environment. This makes it imperative for drug discovery and development efforts to incorporate new technologies in order to reduce time-to-market to survive in today’s competitive marketplace. This industry pressure to shorten the R&D process has seen high-throughput screening (HTS)…

Target validation

20 May 2005 | By Jeroen DeGroot, PhD; Anne-Marie Zuurmond, PhD, Daniel Eefting, MD; Ruud A Bank, PhD; and Paul Quax, PhD.; TNO Quality of Life, Business Unit Biomedical Research

All diseases have a genetic component, whether inherited or resulting from the body's response to environmental stresses such as viruses, toxins or trauma. The successes of the human genome project have enabled researchers to pinpoint errors in genes that cause or contribute to disease.

The promise of pancreatic beta cells

20 May 2005 | By William Carley, Ph.D., Experimental Medicine, Pfizer Global R&D

Biomarker application during drug development is driven by the need to define disease and therapeutic efficacy/safety earlier, better and with reduced cost.

Easy access for the scientific community

20 May 2005 | By Laura Hohmann, Research Associate, Daniel Martin M.D., Director, Proteomics Facility, The Institute for Systems Biology

The past decade has witnessed an explosion in the field of proteomics. This development has been driven by the development of database search algorithms, expansion of sequence databases and improvements in mass spectrometry instrumentation. Quantitative techniques using isotopic dilution have allowed quantitative experiments. The expanding opportunities have propelled the development…

A powerful tool for drug discovery

20 May 2005 | By Jianwei Liu and Clay W Scott, AstraZeneca Pharmaceuticals, Wilmington, USA

Receptor-ligand binding assays are extremely powerful tools in drug discovery. With advances in technology and methodology, the traditional radioligand filtration assays are being replaced with higher throughput homogeneous assays. Non-radioactive methods have been developed recently that are particularly applicable to early phase drug discovery.

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