The development of biosimilar products is expected to grow rapidly over the next five years as a large number of approved biologics reach patent expiry. The pathway to regulatory approval requires that similarity of the biosimilar to the reference product be demonstrated through physiochemical and structural characterization, as well as within in vivo studies that compare the safety and efficac...

The identification, prevention, and prompt treatment of exacerbations are major objectives of asthma management. We looked at change in PEF, symptoms, and use of rescue agonists during the 425 severe exacerbations that occurred during a 12-month parallel group study (FACET) in which low and high doses of budesonide with and without formoterol were compared in patients with asthma. Oral corticos...

BACKGROUND Time-to-pregnancy (TTP) has never been studied in an African setting and there are no data on the rates of adverse pregnancy outcomes in South Africa. The study objectives were to measure TTP and the rates of adverse pregnancy outcomes in South Africa, and to determine the reliability of the questionnaire tool. METHODS The study was cross-sectional and applied systematic stratified...

Treatment of rheumatoid arthritis (RA) has undergone a radical hange in recent years by optimization not only of classical treatents with disease modifying drugs and the introduction of new iological therapies,1–8 but also of the objectives (treat to target) n the shortand long-terms in monitoring and standardization of atients and procedures.9 It is increasingly evident that there is a window ...

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1. Allergic Rhinitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1.1 Pathophysiology and Prevalence in the Elderly . ...

DNA microarrays have made it possible to estimate the level of expression of thousands of genes for a sample of cells. Although biomedical investigators have been quick to adopt this powerful new research tool, accurate analysis and interpretation of the data have provided unique challenges. Indeed, many investigators are not experienced in the analytical steps needed to convert tens of thousan...

Contents Page List of Tables i Acknowledgements iii Executive Summary v Chapter 1 Introduction 1 1.1 Aims and objectives of the study 1 1.2 Scope and limitations of the review 1 Chapter 2 Methods 5 2.1 Identifying relevant literature 5 2.2 Results of the literature search 9 2.3 The process of inclusion and exclusion 9 2.4 Charting the data 12 Chapter 3 The scope and characteristics of the liter...

The NATO RTO Human Factors and Medicine Panel Task Group 017 entitled, “Uninhabited Military Vehicles (UMVs): The Human Factors of Augmenting the Force” involves studying ways to enhance military Forces by leveraging the potential advantages of UMVs to act as force multipliers. This report identifies, prioritizes, and addresses the Human Factors (HF) issues associated with integrating UMVs into...

Mammalian cell culture media used for the manufacture of therapeutic protein have advanced systematically from serum-containing into animal-free, protein-free and chemically defined formulations over the past decades. Initially driven by patient safety concerns associated with the use of animal-derived medium components, and later by inconsistent cell culture performance due to variability in p...