Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

European Glacial Landscapes: Maximum Extent of Glaciations brings together relevant experts on the history of glaciers and their impact on the landscape of the main regions of Europe. In some regions the largest recorded glaciations occurred before the Last Glacial Cycle, in one of the major glacial cycles of the Middle Pleistocene. However, the best-preserved evidence of glaciation in the landscape is from the Last Glacial Cycle (Late Pleistocene). The book also analyses these older glacial landforms that can sometimes still be seen in the landscape today. This analysis provides a better understanding of the succession of Pleistocene glaciations and the intervening interglacial periods, examining their possible continental synchrony or asynchrony of past glacier behaviour. The result of this analysis gives important new insights and information on the origin and effects of climatic and geomorphological variability across Europe. European Glacial Landscapes: Maximum Extent of Glaciations examines the landscapes produced by glaciers throughout Europe, the geomorphological effects of glaciations, as well as the chronology and evolution of the past glaciers, with the aim of understanding the interrelationship between glacial expansion and climate changes on this continent. This book is a valuable tool for geographers, geologist, environmental scientists, researchers in physics and earth sciences.

Value-Chain of Biofuels: Fundamentals, Technology, and Standardization presents the fundamental aspects of biofuel production, from biomass conversion technologies and biofuels' end products to related policy regulation and standardization. Sections explore the current biofuels industry, addressing pretreatment, feedstocks, and conversion processes, review different pathways to produce biofuels, including bioethanol, biochar, biogas/bio-hydrogen, bio-oil, biodiesel, and many others, and finally, present policy regulation and standardization on biofuel production, with a focus on applications. Case studies are provided alongside reviews from academic and industry perspectives, discussing economics and lifecycle assessments (LCA) of biofuel production, as well as analyses of supply chains. Offering a comprehensive and timely overview, this book provides an ideal reference for researchers and practitioners working in bioenergy and renewable energy, but it will also be of interest to chemists, bioengineers, chemical engineers, and the agricultural and petrochemical industries.

Uranium Geology of the Middle East and North Africa demonstrates mining potential in the MENA region, with a special interest given to Uranium. The formation and origin of uranium deposits is of interest for uranium exploration and is necessary for the long-term sustainability of nuclear energy production. The book proposes a new classification system built on earlier classification with detailed new maps, explanatory diagrams, cross sections, helpful satellite images, etc. In addition, it explains why the occurrences, depositional and geological environments of uranium in the Middle East and North Africa vary from one country to another. Using various related recognition criteria, the book reports the potential uranium provinces in the Middle East and North Africa countries. The definition of these provinces is based on the existing geologic and tectonic settings, along with geochronological sequences and geochemical characteristics.

We are at a defining point in the history of news. Following a surge of fake news, clickbait and conspiracy theories, the 2020s have ushered in a welter of existential threats for public service broadcasting. So, where do we go from here? Former Today editor and head of BBC television news Roger Mosey thinks public service broadcasters must buck the trends and in this incisive book he offers twenty core ways in which the news can save itself by getting smarter, sharper, more diverse, more nuanced and less exposed to pummelling by politicians. Mosey sees two possible futures: one in which the incitements of populist demagogues and the passions of social media are ever dominant - or one where we fight hard to retain media that has an interest in the public good and preserves truth, fairness and evidence-based judgements. From one of British broadcasting's most experienced voices comes the definitive exploration of Britain's news output and what must change if we are to avoid a future of uninspiring news, uninformed decision-making and accountability-dodging politicians.

The Oceanography of the Eastern English Channel: Past, Present and Future, Volume 90 in the Advances in Marine Biology series, is the latest release in a series that has been providing in-depth and up-to-date reviews on all aspects of marine biology since 1963. Readers will find updates on many topics that will appeal to postgraduates and researchers in marine biology, fisheries science, ecology, zoology and biological oceanography. Chapters in this new release include Marine Environmental DNA: Approaches, Applications, and Opportunities, and The Biology and Ecology of the Banana Prawns.

Fundamental Issues Critical to the Success of Nuclear Projects presents a complete analysis of the core considerations for those deploying nuclear power plants, managing existing plants, and also for those developing and building new plants. It includes critical considerations, such as cost-estimation, safety procedures, and regulatory compliance, manpower optimization and development, and the application of innovative technologies, such as the use of robotics. Those important issues have been addressed in a systematic way, and explanations have been provided on how the nuclear industry has continuously found solutions to mitigate and eventually solve them properly.

Special Volume on Kogia biology presents in-depth and up-to-date reviews on all aspects of marine biology. Published since 1963, this serial updates on a variety of topics that will appeal to postgraduates and researchers in marine biology, fisheries science, ecology, zoology and biological oceanography.

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