Drug development process

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  • Despite massive efforts in drug discovery fueled by combinatory chemistry, recombinant DNA technology, and highthroughput screening, surprisingly few molecules make it through the drug development process. While the reasons are debated, it is certain that many new chemical entities (NCEs) suffer from recurring problems that hinder development— low water solubility, instability, or inadequate pharmacokinetics. An estimated 43% of NCEs are poorly water-soluble.

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  • The discovery of efficacious new human therapeutic agents is one of humanity’s most vital tasks. It is an enormously demanding activity that requires creativity, a vast range of scientific knowledge, and great persistence. It is also an exceedingly expensive activity. In an ideal world, no education would be complete without some exposure to the ways in which new medicines are discovered and developed. For those young people interested in science or medicine, such knowledge is arguably mandatory....

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  • The primary focus of this chapter in on general approaches and considerations toward development of high-performance liquid chromatography (HPLC) methods for separation of pharmaceutical compounds, which may be applied within the various functions in the drug development continuum. It is very important to understand the aim of analysis and the requirements for a particular method to be developed. The aim of analysis of each HPLC method may vary for each developmental area in the drug development process and specific examples are given in Section 8.2.

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  • Proteins are the driving force for all cellular processes. They regulate several cellular events through binding to different partners in the cell. They are capable of binding to other proteins, peptides, DNA, and also RNA. These interactions are essential in the regulation of cell fates and could be important in drugs development. For example RNA interacting proteins regulate gene expression through the binding to different mRNAs. These mRNAs could be involved in important cellular processes such as cell survival or apoptosis.

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  • In a certain sense, the field of drug metabolism (DM) is standing still. More specifically, the basic experiment of drug metabolism (i.e., administering a new drug to an animal or human and determining the structures, amounts, and disposition of the metabolites) has changed very little over a period of decades. Remarkably, the experimental design and resulting data set from a typical absorption, distribution, metabolism, and excretion (ADME) study conducted today would be instantly recognized and understood by DM scientists from 50 years ago.

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  • Theviewsexpressedtherein,thedesignationsemployedaswellasthepresentationof materialinthispaperdonotimplytheexpressionsofanyopinionwhatsoeveronthepartof theSecretariatoftheUnitedNationsIndustrialDevelopmentOrganizationconcerningthe legalstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthe delimitationofitsfrontiersorboundaries.

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  • Great efficiencies have been achieved in the drug discovery process as a result of technological advances in target identification, high-throughput screening, high-throughput organic synthesis, just-in-time in vitro ADME (absorption, distribution, metabolism, and excretion), and early pharmacokinetic screening of drug leads. These advances, spanning target selection all the way through to clinical candidate selection, have placed greater and greater demands on the analytical community to develop robust high-throughput methods.

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  • The art of compliance is a craft much like that of a carpenter who learns to work with various kinds of wood and designs. Ours is an industry wrought with differences. While the regulations that govern FDA-regulated industries are proscribed, how the regulations are interpreted and applied really depends on experience and how well one has mastered the craft of compliance. There are no proscribed procedures, but there are guideposts common to all FDA-regulated industries, whether a firm manufactures medical devices, pharmaceuticals, or biological products....

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  • In the drug discovery area, a compound with desired therapeutic properties is identified, and its structure may be modified by synthetic alterations to enhance potency and specificity or to decrease toxicity and undesired side effects. The lead drug candidate is then transitioned into the drug development area. Only small amounts of drug (typically less than a gram) are required to support the required studies in the Drug Discovery area. However larger amounts are required to support the studies conducted in the Drug Development area.

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  • In other words, we exclude both the analysis of other (non-economic) foreign policies with an impact on the development of development-aid-receiving countries, and the coherence between the instruments and objectives of international development cooperation policy. Some of these aspects are covered in previous papers on the coherence of Spain’s development policies, such as Alonso and FitzGerald (2003). Very broadly speaking, the development of aid-receiving countries has been established as the objective we have to be consistent with.

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  • Addiction is a terrible thing. It consumes and controls us, makes us deny important truths and blinds us to the consequences of our actions. Our world is in the grip of a dangerous carbon habit. Coal and oil paved the way for the developed world’s industrial progress.

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  • Many cancer patients are diagnosed at a stage in which the cancer is too far advanced to be cured, and most cancer treatments are effective in only a minority of patients undergoing therapy. Thus, there is tremendous opportunity to improve the outcome for people with cancer by enhancing detection and treatment approaches. Biomarkers will be instrumental in making that transition.

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  • Information technology is another approach to transfer skills. Hiekata et al. (2005A, 2005B, 2006, 2007) developed knowledge transfer system, which can be applied effectively to acquire knowledge of elder experts. The characteristics of each job were revealed through questionnaire and structured interviews, and the job process is analysed and represented by workflow and related documents, where tacit knowledge of some tasks can be turned to explicitly documented knowledge.

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  • The method validation process is to confirm that the method is suited for its intended purpose. Although the requirements of validation have been clearly documented by regulatory authorities [ICH, USP, and FDA], the approach to validation is varied and open to interpretation. Validation requirements differ during the development process of pharmaceuticals. The method validation methodologies in this chapter will focus on the method requirements for preliminary and full validation for both drug substance and drug product.

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  • Developing fast high-performance liquid chromatography (HPLC) methods can improve work efficiency during research, development, or production of a drug substance or a drug product. HPLC is a key technique in all of these areas. Until recently, analysis times of greater than 30 minutes were common. Modern pharmaceutical R&D, with its high-throughput screening, demands high-throughput methods to deal with the large number of samples. To reduce production cycle time, fast HPLC methods are essential for on-line or at-line process control and for rapid release testing.

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  • A third of all general practice consultations are for musculoskeletal complaints. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used, and their gastrointestinal effects account for an estimated 1200 deaths per year in the UK. A hitherto unsuspected inflammatory component is now known to accompany conditions such as atherosclerosis. As understanding of the complex mechanisms underlying the inflammatory process increases, new ways of influencing it are developed, as witness therapies directed against specific cytokines, and COX-2 specific NSAIDs (COXIBs). ...

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  • The milk production system in Pakistan is characterized by large numbers of small, geographically dispersed dairy producers who have marketable surpluses of milk but face diseconomies of scale in marketing it to demand centers in distant urban areas. The traditional middlemen who procure milk from rural areas close to the cities offer at best modest returns to the farmers. In the past couple of decades, two institutional developments have taken place in the milk processing sector.

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  • The general meaning of gene therapy is to correct defective genes that are responsible for disease development. The most common form of gene therapy involves the insertion, alteration or removal of genes within an individual's cells and biological tissues. Many of gene transfer vectors are modified viruses. The ability for the delivery of therapeutic genes made them desirable for engineering virus vector systems. Recently, the viral vectors in laboratory and clinical use have been based on RNA and DNA viruses processing very different genomic structures and host ranges.

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  • The urgent need to ensure the conservation of biological diversity is now widely recognised, but the role of an intellectual property rights regime as an instrument for biodiversity conservation is poorly understood and often hotly debated. This volume is a detailed analysis of the economic and scientific rationales for the use of a property rights-based approach to biodiversity conservation. It discusses the justification for, and implemen- tation of, intellectual property rights regimes as incentive systems to encourage conservation.

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  • These guidelines use sustainable urban infrastructure as the entry point for building sustainable cities. Sustainable urban infrastructure can only be built if we reconsider our strategic view of urbanization – if we rethink the future of cities. A new strategy based on more effective urban planning, strengthened local institutions and governance processes as well as enhanced economic contribution of cities is needed.

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