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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…
In this Mass Spectrometry In-Depth Focus: Corticosteroids and mass spectrometry; latest applications using LC/MS; Multi-analyte LC-MS/MS assays for the quantification of endogenous compounds during the development of drugs and companion diagnostics...
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…
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…
18 December 2012 | By D. Lansing Taylor, Director, University of Pittsburgh Drug Discovery Institute and Allegheny Foundation Professor of Computational and Systems Biology, University of Pittsburgh School of Medicine
The pharmaceutical industry has experienced a decade of turbulence driven by the ‘patent cliff’ as major revenue generators are lost to generic status, coupled to the absence of a sustainable pipeline of drug candidates in development that have a good chance of being approved and launched. It is generally agreed…
22 October 2012 | By Henning Gieseler, Associate Professor at the Division of Pharmaceutics, University of Erlangen & CEO, GILYOS GmbH and Peter Stärtzel, Pharmaceutical Scientist, GILYOS GmbH
The stochastic nature of nucleation during the freezing step of the freeze-drying process has been regarded as a demerit in a process which is considered under rigorous control. The freezing performance of a product can impact its subsequent drying behaviour and the final product quality attributes. Hence, the idea to…
3 September 2012 | By David Cook & James Milligan, AstraZeneca
Ensuring patient safety during clinical trials is of paramount consideration with stringent monitoring built into trials (and beyond) and the design and interpretation of safety outcomes subject to a large amount of regulation. As a result, it is rare for clinical trials to produce extreme adverse drug reactions but it…
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…
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.
Michael J. Valazza R.Ph., Vice President, Global Modified Release Technologies, Catalent Pharma Solutions, will be presenting on “Recent Advances in Oral Granules and Fixed Dose Tablet technologies, OptiMeltTM Solubility Enhancement Solutions, and Oral Disintegrating Tablet applications,” on Sunday, July 15th from 10:15AM -11:15AM as part of a releasing technology workshop…
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…
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…
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…
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,…
26 April 2012 | By Geir Rune Flåten, former Chemometrician Leader in Global Manufacturing and Supply at GlaxoSmithKline
Chemometrics was defined as a research area in 1974 and developed rapidly through the following decades in parallel with the fast paced improvement in analytical technologies and computational power for lab instruments and sensors. Chemometrics is essentially the translation of measured signals characterising a sample or a process into meaningful…
