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Figure 1: Typical product temperature profiles during uncontrolled nucleation indicated by thermocouples placed centre bottom within the vial. 1: degree of supercooling; 2: nucleation temperature, Tn; 3: equilibrium freezing temperature, Tf.
Figure 1: Typical product temperature profiles during uncontrolled nucleation indicated by thermocouples placed centre bottom within the vial. 1: degree of supercooling; 2: nucleation temperature, Tn; 3: equilibrium freezing temperature, Tf.
article

Controlled nucleation in freeze-drying

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…

Man on a phone analysing data and charts on computer screen
Man on a phone analysing data and charts on computer screen
article

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…

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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.

Catalent logo
Catalent logo
news

Recent advances in controlled release, solubility, and ODT applications presented by Catalent expert

11 July 2012 | By

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…

Pills Powder
Pills Powder
article

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…

article

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…

FIGURE 1 Parties involved in the biomarker discovery and validation process. Medical Science is responsible for sample collection, pre-classification and storage in biobanks. Analytical Chemistry is responsible for developing sample preparation protocols and analytical platforms both for comprehensive biomarker discovery on low numbers of samples as well as for the targeted validation in large sample cohorts. Bioinformatics is responsible for performing the data pre-processing and statistical analysis as well as the validation of data and clinical information provided by the analytical and medical partners. A close collaboration and information exchange is essential for the success of biomarker research
FIGURE 1 Parties involved in the biomarker discovery and validation process. Medical Science is responsible for sample collection, pre-classification and storage in biobanks. Analytical Chemistry is responsible for developing sample preparation protocols and analytical platforms both for comprehensive biomarker discovery on low numbers of samples as well as for the targeted validation in large sample cohorts. Bioinformatics is responsible for performing the data pre-processing and statistical analysis as well as the validation of data and clinical information provided by the analytical and medical partners. A close collaboration and information exchange is essential for the success of biomarker research
article

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…

What is label-free screening and why use it in drug discovery?
What is label-free screening and why use it in drug discovery?
article

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,…

Implementing chemometrics in late stage development and manufacturing
Implementing chemometrics in late stage development and manufacturing
article

Implementing chemometrics in late stage development and manufacturing

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…

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Applications of Raman, CARS and SRS imaging in dosage form development

26 April 2012 | By Clare Strachan, Senior Lecturer Pharmaceutical Sciences, School of Pharmacy, University of Otago

The use of Raman spectroscopy in pharmaceuticals has grown enormously since its appearance on the scene in the 1980s1-4. While typical Raman spectroscopy setups are able to provide chemical and physicochemical information about the sample on the bulk level, most solid samples in the pharmaceutical setting may not be assumed…

FIGURE 1miRNAs can impact viral infection directly by interacting with viral genes or indirectly by regulating host genes that play a role in the infection. miRNAs are derived from transcripts that contain stem-loop structures which get recognised and processed by a series of enzymes to generate the short (~22 nt) duplex RNA. One strand of the duplex is preferentially incorporated into the RNA-induced silencing complex (RISC) and guides this complex to mRNAs or other viral elements that contain regions of complementarity to the miRNA
FIGURE 1miRNAs can impact viral infection directly by interacting with viral genes or indirectly by regulating host genes that play a role in the infection. miRNAs are derived from transcripts that contain stem-loop structures which get recognised and processed by a series of enzymes to generate the short (~22 nt) duplex RNA. One strand of the duplex is preferentially incorporated into the RNA-induced silencing complex (RISC) and guides this complex to mRNAs or other viral elements that contain regions of complementarity to the miRNA
article

microRNA manipulation as a host-targeted antiviral therapeutic strategy

13 December 2011 | By Nouf N. Laqtom, University of Edinburgh & King Abdulaziz University and Amy H. Buck, University of Edinburgh

microRNAs (miRNA) are a class of non-coding RNA that regulate the precise amounts of proteins expressed in a cell at a given time. These molecules were discovered in worms in 1993 and only known to exist in humans in the last decade. Despite the youth of the miRNA field, miRNA…

FIGURE 1 The rapid evolution of sequencing technologies. A. First generation Sanger sequencing technology. B. Second ‘Next’ generation massively parallel sequencing technology (454 Sequencing © Roche Diagnostics) C. Third ‘Next-Next’ generation single molecule, real-time sequencing technology. In the coming years, second or third generation technologies may develop to an extent where a human genome can be sequenced for a USD 1,000 in a matter of hours
FIGURE 1 The rapid evolution of sequencing technologies. A. First generation Sanger sequencing technology. B. Second ‘Next’ generation massively parallel sequencing technology (454 Sequencing © Roche Diagnostics) C. Third ‘Next-Next’ generation single molecule, real-time sequencing technology. In the coming years, second or third generation technologies may develop to an extent where a human genome can be sequenced for a USD 1,000 in a matter of hours
article

DNA sequencing technologies and emerging applications in drug discovery

13 December 2011 | By Nalini A.L. Mehta & David J. Dow, Molecular and Cellular Technologies, Platform Technology and Science, GlaxoSmithKline and Anthony M. Battram, Molecular and Cellular Technologies, Platform Technology and Science, GlaxoSmithKline & Department of Life Sciences, Imperial College London

In recent years, the development of Next Generation DNA Sequencing (NGS) technology has significantly impacted molecular biology research, resulting in many new insights and discoveries. NGS technology goes beyond traditional DNA sequencing with applications that reach across the central dogma of molecular biology from DNA to RNA and protein science.…

fig 1 for wen
fig 1 for wen
article

Spray drying pharmaceuticals

13 December 2011 | By Mingshi Yang, Faculty of Pharmaceutical Sciences, University of Copenhagen

Spray drying is a widely used technical method to produce fine particles, coarse powders, agglomerates or granulates in various industries. The characteristics of the particles produced by this method can be controlled and the particle properties can be maintained as constant throughout a continuous operation. The product from this process…

FIGURE 1 Structures of active and inactive conformations of the β2 adrenoceptor Structures of the β2 adrenoceptor (light grey) in an inactive conformation with the antagonist carazolol bound (left33), and in an active conformation in complex with Gs (dark grey) and the agonist BI-167107 bound (right41). In both cases, the ligand is represented by black spheres to show the location of the orthosteric binding site within the membrane-spanning region of the protein. T4 lysozyme (black) is inserted in the third intracellular loop between helices 5 and 6 in the inactive structure (bottom left), and fused in the extracellular N-terminus for the active structure (top right), to remove flexibility and to provide polar surfaces for crystallisation. The nanobody (black, bottom right) served to stabilise the open conformation of Gs and also provided crystallisation contacts
FIGURE 1 Structures of active and inactive conformations of the β2 adrenoceptor Structures of the β2 adrenoceptor (light grey) in an inactive conformation with the antagonist carazolol bound (left33), and in an active conformation in complex with Gs (dark grey) and the agonist BI-167107 bound (right41). In both cases, the ligand is represented by black spheres to show the location of the orthosteric binding site within the membrane-spanning region of the protein. T4 lysozyme (black) is inserted in the third intracellular loop between helices 5 and 6 in the inactive structure (bottom left), and fused in the extracellular N-terminus for the active structure (top right), to remove flexibility and to provide polar surfaces for crystallisation. The nanobody (black, bottom right) served to stabilise the open conformation of Gs and also provided crystallisation contacts
article

Lead discovery for targeting G protein-coupled receptors

19 October 2011 | By Sandra Siehler and Sandra W. Cowan-Jacob, Novartis Institutes for BioMedical Research

G protein-coupled receptors (GPCRs) control a plethora of key physiological functions in every cell of an organism. GPCRs are therefore involved in many diseases, since altered ligand or receptor levels and genetic or epigenetic modifications can lead to GPCR dysfunction and hence a pathophysiological phenotype. About one third of currently…