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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
Integrating preclinical data into early clinical development
3 September 2012 | By Vikash Sinha, Clinical Pharmacology Leader, Janssen Research and Development
One of the important goals in preclinical and early clinical drug development is to reduce attrition rates and to improve our ability to pick winners and drop potential loser drug candidates. By being able to efficiently translate preclinical data and observations into possible clinical outcomes, one can make the drug…
Under the microscope: Graeme Lowe, Catalent
3 September 2012 | By Helen Bahia, Editor, European Pharmaceutical Review
Graeme Lowe, Director of Development and Analytical Solutions at Catalent, discusses outsourcing pharmaceutical development and analytical solutions.
Informatics In-Depth Focus 2012
In this Informatics In-Depth Focus: Developing Informatics for the pharmaceutical industry; Rolling out a biology ELN at UCB Pharma; Ask the Informatics experts; Laboratory Informatics – Out of the fog and into the cloud?
A reduction to practise for siRNA screening utilising high conent analysis (HCA) technologies
10 July 2012 | By Anthony Mitchell Davies & Anne Marie Byrne, Department of Clinical Medicine Trinity College Dublin; Holger Erfle, BIOQUANT-Zentrum Ruprecht-Karls-Universität Heidelberg; Graham Donnelly, Rita Murray & Peadar MacGabhann, Biocroi Ltd
One of the major limitations of performing large-scale High Content Analysis (HCA) screens is reagent cost, indeed this fact has been a key driver in the development of assay size reduction strategies here at The Irish National Centre for High Content Screening and Analysis at Trinity College’s Department of Medicine.…
Evolution of drug metabolism and pharmacokinetics in drug discovery and development
10 July 2012 | By Dr. Dermot McGinnity, Innovative Medicines, AstraZeneca R&D
Drug Metabolism and Pharmacokinetics (DMPK) is a scientific discipline once primarily associated with safety evaluation in drug development that has, in the last two decades, become a core discipline within drug discovery, development and even post-marketing. Approximately 20 years ago, sub-optimal DMPK properties were recognised as a contributor to the…
Breaking old habits: Moving away from commonly used buffers in pharmaceuticals
10 July 2012 | By David Sek, Research Scientist, Pfizer
One of the key factors in stabilising proteins is determining the optimal pH and buffer system to provide adequate solubility and stability. Currently, three buffers, citrate, phosphate and acetate, make up the majority of buffers used in parenteral pharmaceuticals approved by the FDA, but less precedented excipients are certainly available…
Applications of thermally stimulated current spectroscopy in pharmaceutical research
10 July 2012 | By Milan Antonijević, School of Science, University of Greenwich
Thermally Stimulated Current Spectroscopy (TSC) is a new tool that can be used to analyse pharmaceutically important molecules. TSC studies are usually conducted to provide additional information about molecular mobility in the solid state, and as a result characterise phase transitions that are related to thermal transitions in the crystalline…
Discovery and validation of protein biomarkers
10 July 2012 | By Péter Horvatovich & Rainer Bischoff, Analytical Biochemistry, Department of Pharmacy, University of Groningen
Biomarkers are biological characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention. Biomarkers can be used to determine disease onset, progression, efficacy of drug treatment, patient susceptibility to develop a certain type of disease or predict efficacy…
Ten years of siRNA – a clinical overview
10 July 2012 | By Katharina Bruno, Principal Scientist, Technical Research & Development (TRD), Novartis Pharma AG
In 2001, small interfering RNA (siRNA) was discovered as the mediator of RNA interference (RNAi), a transient and specific repression mechanism of protein expression1. After the pharmaceutical industry became aware of the intrinsic versatility and potential of this molecule, a race to develop the first siRNA based drug began. However,…
Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations
10 July 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the third paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Rapid sterility testing is one of a number of applications that novel microbiological technologies afford the pharmaceutical industry. RMM technologies have already been validated and implemented for…
The need for proteomic-based biomarkers in the drug development pipeline
10 July 2012 | By Paul C. Guest, Department of Chemical Engineering and Biotechnology, University of Cambridge and Sabine Bahn Department of Chemical Engineering and Biotechnology, University of Cambridge & Department of Neuroscience, Erasmus Medical Centre
Pharmaceutical companies are under increasing pressure to improve their efficiency and returns on drug discovery projects. This is a daunting task considering that the average drug costs approximately one billion US dollars to develop and takes around 12 years from initial discovery to reach the market1. In addition, approximately 70…
Under the microscope: Foster Jordan, Senior Vice President, Charles River
Foster Jordan, Corporate Senior Vice President, Endotoxin and Microbial Detection, Charles River discusses QC testing and why it is so important in the pharmaceutical industry.
Process Analytical Technology (PAT) In-Depth Focus 2012
In this PAT In-Depth Focus: Process analytics experiences in biopharmaceutical manufacturing; Correlation between powder rheology data and processability in solid dosage form manufacturing; Expert industry users of process analytical technologies for pharmaceuticals pose questions for leading vendor experts of process analytical technology...
Stem Cells In-Depth Focus 2012
In this Stem Cells In-Depth Focus: Stem cell therapies: Assuring safety; Role of pluripotent stem cells in neurotoxicology testing: Impacts and applied innovations...
At the crossroads: The next decade
26 April 2012 | By J. Paul Robinson, Purdue University Cytometry Laboratories & Weldon School of Biomedical Engineering, Purdue University; Bernd Bodenmiller, Group leader, Institute of Molecular Life Sciences, University of Zurich; Valery Patsekin and Bartek Rajwa, Purdue University Cytometry Laboratories, Purdue University; and V. J. Davisson, Medicinal Chemistry & Molecular Pharmacology, Purdue University
Flow cytometry is the technology that has the most impact on single-cell analysis. Over the past 40 years, it has arguably been the single most important research technique in the fields of basic and applied immunology. Flow cytometry excels in quantitative evaluation of receptor expression, separation of functionally defined cell…
