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# Articles

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### ebook: Extractables and leachables: a guide to analytical methods

26 January 2023 | By

This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.

### 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…

### A process analytical tool

7 March 2005 | By Jukka Rantanen, Senior Research Scientist, Viikki Drug Discovery Technology Centre, University of Helsinki

There is an increasing demand for new approaches to understand the chemical and physical phenomena that occur during pharmaceutical unit operations. Obtaining real-time information from processes opens new perspectives for safer manufacture of pharmaceuticals. Raman spectroscopy provides a molecular level insight into processing and it is therefore a promising process…

### Changing the paradigm: Expanding High Content Imaging for early cytotoxicity assessments

7 March 2005 | By Ann F. Hoffman, Senior Principal Scientist, Roche Discovery Technologies

There is no single solution to achieving these goals; however there are underutilised tools that provide drug discovery efforts with richer data sets for more prudent/intelligent decision making. Tools that have already emerged into the forefront to await impact upon the process include the use of automated patch clamp technologies…

### Dosing and weighing in the pharmaceutical laboratory

7 March 2005 | By Dr. Ulrich Schopfer, Global Head of Compound Management, Dr. Frank Hoehn, Laboratory Head, Automation, Matthieu Hueber, Automation Engineer, Novartis Institutes for BioMedical Research

Dispensing of solids is still a demanding task in laboratory automation. The solubilisation of High Throughput Screening (HTS) libraries is one of the most challenging problems in this area, since millions of different substances have to be processed by the same technology.

### Versatile miniaturised HTS

7 March 2005 | By Oliver Bruttger, Danielle Folio, Christine Niklaus and Johannes Ottl, Novartis Institute for BioMedical Research, Lead Discovery Center Basel

Research and development for a pharmaceutical company is a difficult and lengthy process. It stretches from the discovery phase to preclinical and clinical development stage, through the drug approval period ultimately to clinical application. The discovery research phase is one of the early key processes. The research starts with target…

### PAT for API

7 March 2005 | By Dirk C. Hinz, Ph.D., Schering AG, Corporate CMC Development, In-Process Control Dept.

Pharmaceutical manufacturing occurs in a highly regulated environment, where most of the manufacturing is performed in batches, in stop-and-go steps and with off-line testing of product quality. Additionally, due to patent restrictions, there is always ‘speed to market’ pressure.

### Excellence by design

7 March 2005 | By Simon Routledge, Head of GMP Manufacturing, Eden Biodesign

A desire to build on the bio-manufacturing expertise already present in North West England and the requirement to support UK biotechnology growth as a whole has led the North West Development Agency to sponsor the establishment of a National Biomanufacturing Centre (NBC) in Liverpool. The NBC is due to open…

### Management strategies for risk assessment

7 March 2005 | By Dr Monika Sauter, Director, Global Quality Assurance Operations and Tim Lloyd, Editor

A safe, effective and state-of-the-art cleanroom requires significant investment and manpower. To sustain long-term development and meet objectives, as well as maintain a contamination-free environment, it is essential that sound procedures are in place from day one, as part of a dedicated management program.

### Who nose?

7 March 2005 | By Professor Richard Dalby and Yang Guo, University of Maryland School of Pharmacy, Julie Suman, Next Breath LLC

In 2003 worldwide sales of allergic rhinitis nasal sprays alone were valued at US$2.4B (IMS, Valois), up from 2002 worldwide sales of all over-the-counter (OTC) nasal sprays except steroids, estimated at US$820M (IMS, Valois). That’s a significant amount of drug administered via the nose every year (Figure 1). With a…