This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be...
This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in ...
Systems Biology (SB) is a suite of technologies and methodologies that resulted, conceptually from the merging of two basic paradigms, reductionism and holism with the goal of identifying its emergent properties and defining, quantitatively, molecular, cellular, tissue, organ and whole body processes. One manifestation of SB is as a tool for hypothesis generation about a system that is typically too large and complex to understand by simple reasoning.
The US is currently well ahead of the rest of the world in the development and application of SB and its principles especially...
Systems Biology (SB) is a suite of technologies and methodologies that resulted, conceptually from the merging of two basic paradigms, reductionism...
This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a product's lifespan on the market...
This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview...
Macromolecular (specifically peptide-based) drugs could potentially be highly effective medicines. However they have a relatively short duration of action and variable therapeutic index. An example of such a peptide is Glucagon-like Peptide I which could potentially be used as a revolutionary drug for diabetes. This is because it stimulates insulin only when the blood glucose level is high thereby reducing the risk of hypoglycemia (a significant disadvantage of using insulin is that an insulin overdose is the single most potent cause of life-threatening hypoglycemia). However it s short...
Macromolecular (specifically peptide-based) drugs could potentially be highly effective medicines. However they have a relatively short duration of...
The natural world with a large number of terrestrial and marine plants and lower organisms is a great source of bioactive compounds historically used as remedies in various diseases. Within the last decade, such compounds became more attractive targets for pharmacologists and the pharmaceutical industry in drug development projects. This volume presents the pharmacological potential of chemically defined natural compounds obtained from plants, fungi, algae and cyanobacteria with antiparasitic activity, that have been tested against various endo-parasitic protozoan and helminth species....
The natural world with a large number of terrestrial and marine plants and lower organisms is a great source of bioactive compounds historically used ...
Good Laboratory Practices for Forensic Chemistry acknowledges the limitations that often challenge the validity of data and resultant conclusions. Eight chapters examine current practices in analytical chemistry as well as business practices, guidelines and regulations in the pharmaceutical industry to offer improvements to current practices in forensic chemistry. It discusses topics ranging from good manufacturing practices (GMP), good laboratory practices (GLP), the International Conference on Harmonisation (ICH), quality assurance (QA), and quality risk management (QRM), among...
Good Laboratory Practices for Forensic Chemistry acknowledges the limitations that often challenge the validity of data and resultant conclusio...
What are lipid nanoparticles? How are they structured? How are they formed? What techniques are best to characterize them? How great is their potential as drug delivery systems? These questions and more are answered in this comprehensive and highly readable work on lipid nanoparticles. This work sets out to provide the reader with a clear and understandable understanding of the current practices in formulation, characterization and drug delivery of lipid nanoparticles. A comprehensive description of the current understanding of synthesis, characterization, stability optimization and...
What are lipid nanoparticles? How are they structured? How are they formed? What techniques are best to characterize them? How great is their p...
This volume presents recent developments in the novel drug development and potential of extremophilic cyanobacteria. It discusses how these tiny organism originated, produce oxygen that leads to evolution of life on the earth, how their survival strategies in extreme climatic conditions lead to diverse metabolic pathways, and the opportunity to use them to develop novel drugs. The book is comprised of five chapters, starting with the origin of cyanobacteria, their survival strategies under extreme conditions, and their capabilities to change metabolic activities.The second chapter explores...
This volume presents recent developments in the novel drug development and potential of extremophilic cyanobacteria. It discusses how these tiny or...
This book provides an up-to-date review of recently identified natural anti-tumor compounds from various natural origins including plants, fungi, endophytic fungi and marine organisms. It also includes discussion of new areas such as biotechnology and nanoparticles.
Chapters explain the challenges and developments in anti-cancer drug discovery approaches, traditional remedies for prevention and treatment of cancer, marine-derived anti-cancer compounds, and antibiotics used as anti-cancer agents, as well as different classes of terpenoids and carbohydrates, which have been the subject of...
This book provides an up-to-date review of recently identified natural anti-tumor compounds from various natural origins including plants, fungi, endo...
This book reviews a number of issues including: Why data generated from POC machines are considered as Big Data. What big data technologies and tools can be used efficiently with data generated from POC devices?
This book reviews a number of issues including: Why data generated from POC machines are considered as Big Data. What big data technologies and tools ...
