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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
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.
Integration of miniaturisation technologies
20 May 2005 | By Peter Hodder, Ph.D., Director & Head of Lead ID, Scripps Florida
In pharmaceutical drug discovery research, several technological advances have moved in vitro biological and biochemical experiments from the laboratory benchtop to fully automated high-throughput screening (HTS) robotic platforms1,2.
Getting a handle on neuronal behaviour in culture
20 May 2005 | By Peter B. Simpson, Senior Research Fellow – Automated imaging, Neuroscience Research Centre, Merck Sharp and Dohme
In drug discovery for CNS diseases, the use of complex neural cell culture systems offers many advantages. Innovations in high content screening enable us to identify compounds which affect key cell biological properties in such cultures. We can bridge the divide between kinetic and endpoint screening by use of another…
Patch clamp electrophysiology steps up a gear
20 May 2005 | By Derek J. Trezise, Assay Development & Compound Profiling, GlaxoSmithKline Research & Development
The advent of higher throughput patch clamp electrophysiology systems has begun to change the face of ion channel drug discovery. Systems such as IonWorksHT, PatchXpress and QPatch should allow electrophysiology to be re-positioned from an occasional reagent and compound ‘spot-check’ method, to a frontline gene expression analysis tool and drug…
Exploring new sources of raw material
20 May 2005 | By Bernhard Schrader, Institut für Physikalische und Theoretische Chemie, Universität Duisburg-Essen and Hartwig Schulz, Federal Centre for Breeding Research on Cultivated Plants, Institute of Plant Analysis
Raman spectroscopy using excitation in the near infrared allows non-destructive Raman analyses of pharmaceutical products as well as of plant or animal tissues. This radiation excites only minimal fluorescence of the samples or impurities and has only minimal photo-physical and photochemical activity. Raman analysis of plants allows the efficient exploration…
Harbinger of change
20 May 2005 | By Ali Afnan, Ph.D., Process Analytical Technologist, FDA/CDER/OPS
The pharmaceutical industry plays a major role in the lives of individuals by providing critical therapeutic medicines. This places the industry in the public eye, as does drug pricing, safety and efficacy, the stock markets and courting with several different regulatory bodies, with differing legal requirements, around the world. The…
Implementation, validation and registration
20 May 2005 | By Paul J Newby PhD, GlaxoSmithKline R&D
In the last decade interest in Rapid Microbiological Methods (RMMs) has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and…
The future of process design
20 May 2005 | By Salvatore Mascia, Department of Chemical Engineering, University of Cambridge
Rheology – not to be confused with theology – represents an important and distinctive area of modern engineering science: the ability to specify and control a material's rheology and associated microstructures is a key aspect of many process and product innovations. In the pharmaceutical sector, emulsions and the cohesive wet…
Die-wall stress measurement
20 May 2005 | By Stephen W. Hoag, Ph.D., School of Pharmacy, University of Maryland
Many of the physical factors that affect tablet quality are formed during compaction. Thus, the accurate measurement of tablet compaction will help researchers to better understand compaction and die-wall stress measurements are a critical aspect of being able to measure and understand the three-dimensional nature of compaction.
Ten steps to success
20 May 2005 | By Dr Christopher Haas, Senior Director Pharmaceutical Technology, Schering Plough Corporation
The technology transfer management process reflects an integrated approach to the best practices benchmarked. A well-defined and well-designed technology transfer process is critical for ensuring successful commercial launch. Technology transfer includes manufacturing, packaging and test method transfer to commercial sites.
Forging therapeutics from small interfering RNAs
7 March 2005 | By Olaf Heidenreich, Department of Molecular Biology, Interfaculty Institute for Cell Biology, Eberhard Karls University Tübingen
Small interfering RNAs are irreplaceable tools for the functional analysis of pathological gene products. Therapeutic siRNA development leads to new treatment strategies for gene products, where conventional small molecule approaches have failed.
Applications in drug development
7 March 2005 | By Thorir D. Bjornsson, MD, PhD, Translational Development, Wyeth Research
The past decade has witnessed a growing interest in biomarkers, previously referred to as pharmacodynamic markers, PD markers, or pharmacologic read-outs. This increasing interest has been largely driven by evolutionary changes in drug discovery and development and in regulatory science1,2,3. One key driver has involved the increasing need to reach…
A network of innovation from Canada
7 March 2005 | By Dr Daniel Boismenu, Team Leader, Mass Spectrometry Unit, Montreal Proteomics Network
The Réseau Protéomique de Montréal Proteomic Network (RPMPN) was created in the year 2000 through funding from Genome Canada, Genome Québec and the Canadian Foundation for Innovation. For the past five years, the RPMPN has been involved in the Cell Map Project, which involves cell biologists from the Université de…
Evaluating drug safety
7 March 2005 | By Donald G. Robertson, Metabonomics Evaluation Group, Departments of Worldwide Safety Sciences and Michael D. Reily, Discovery Technologies, Pfizer Global Research and Development
Metabonomics has been defined as the “the quantitative measurement of the time-related multi-parametric metabolic response of living systems to pathophysiological stimuli or genetic modification”1. In simple terms it is a powerful tool for assessing the metabolic component of systemic response.
New phases for rapid ion analysis
7 March 2005 | By Dr Brett Paull and Prof. Pavel Nesterenko, Research Scientists, National Centre for Sensor Research, Dublin
Ion chromatography (IC) is currently used throughout chemical and pharmaceutical industries for the quantitative determination of inorganic and organic anions and cations in a variety of matrices from both raw materials to finished products. In most cases, suppressed IC is utilised, particularly for the determination of inorganic anions and this…
