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Global Biosimilar Development
| By PRA Health Sciences
Many different terms are used in different parts of the world to describe “biosimilar products.” It is important to understand and differentiate true biosimilars from others because of the potential concern for patient safety and efficacy, and the misconceptions that can arise from misleading published reports.
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Global Capabilities in Central Nervous System Research
| By PRA Health Sciences
PRA Health Sciences’ (PRA) Early Development Services (EDS) group has a long-standing track record of early clinical development work in various CNS indications through our global clinical facilities.
White Papers
Cystic Fibrosis: Pulmonary Aspects of the Disease
| By Cromsource
Cystic fibrosis (CF) is a genetic disease which is usually caused by the absence, dysfunction or reduced number of the multifunctional CF transmembrane regulator (CFTR) protein... Recently new therapy approaches such as ivacaftor have emerged which target the cause of the condition itself. This white paper focusses only on the current treatment of pulmonary complications of CF.
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Studying Low-Affinity Fragments of Ligands by ITC
| By Malvern Instruments
Molecular recognition is a fundamental prerequisite to all biological processes from enzymatic catalysis to signal transduction. The modern pharmaceutical industry is built upon the concept of selective intervention in such systems (1). Furthermore, similar concepts are being implemented, through supramolecular chemistry, to develop novel smart materials, components for nanotechnology and molecular electronics (2). If we are to harness the full potential of molecular recognition, it is essential that we understand the subtle interplay between structure and thermodynamics in complex formation.
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Pharmaceutical Excipient Characterisation
| By Malvern Instruments
The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product. These are generally identified through an assessment of the extent to which the variation in a specific attribute, for example particle size, can impact the drug product’s quality and performance.
White Papers
Differentiation and Characterisation of Subvisible Particulates in Therapeutic Protein Products
| By Malvern Instruments
The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life.
White Papers
Revealing Kinase Inhibitor Mechanisms: ITC Leads the Way
| By Malvern Instruments
The kinome of an organism is the set of protein kinases in its genome and these protein-modifying enzymes are potential targets in a number of therapeutic areas. Studies to characterise the human kinome, together with the explosion of available kinase crystal structures over recent years, have led to an increased focus on kinases as potential targets for pharmaceutical intervention.
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Ten Ways to…Optimise Rheology to Increase Dispersion/Colloidal/Emulsion Stability
| By Malvern Instruments
The following ten points highlight general methods of designing and interpreting rheological tests to optimise sample stability.
White Papers
Identification of Agglomerates Using Automated Image Analysis
| By Malvern Instruments
The identification of agglomerates is seen as a challenge across many different industries. Automated image analysis systems provide a means for the classification of agglomerates, by differentiating particles based on their morphological parameters. The inclusion of spectroscopic measurements alongside imaging (MDRS) aids in understanding the type of agglomeration occurring with the sample.
White Papers
Sponsor and CRO Pharmacovigilance Alliances
| By PRA Health Sciences
Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. In the past, outsourced safety services were limited due to concerns about confidentiality, data security and liability in cases of regulatory non-compliance, which are all still important considerations today.
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