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.

Annual Reports in Medicinal Chemistry, Volume 57 in this long-running series, highlights new advances in the field with this new volume presenting interesting chapters on the Mechanism of action of the broadly acting antiviral drug remdesivir, Improving properties of the nucleobase analogue T-706 as a potential anti-SARS-CoV-2 and anti-influenza compound, Antivirals for RNA virus infections Anno 2020-2021, Broad spectrum antiviral fleximer nucleosides, SARS-CoV-2 main protease inhibitors, The search for antivirals to treat alphavirus infections, Inhibitors of Ebola Virus targeting Innate immune evasion, Uracil derivatives as non-nucleoside inhibitors of viral infections, and more.

Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 43, first published in 1977, and continually published as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs, presents clinicians and medical investigators with a critical survey of new data and trends in adverse drug reactions and interactions. Topics covered in this new release include Central Nervous System Stimulants and Drugs that Suppress Appetite, Antidepressants, Lithium, Drugs of Abuse, Hypnotics and Sedatives, Antipsychotic Drugs, Antiepileptics, Opioid Analgesics and Narcotic Antagonists, Anti-Inflammatory and Antipyretic Analgesics and Drugs Used in Gout, and much more.

Advances in Pharmacology series, highlights new advances in the field, with this new volume presenting interesting chapters. Each chapter is written by an international board of authors.

Water containing significant amounts of inorganic and organic contaminants can have serious environmental consequences and serious health implications when ingested. Contamination of Water: Health Risk Assessment and Treatment Strategies takes an interconnected look at the various pollutants, the source of contamination, the effects of contamination on aquatic ecosystems and human health, and what the potential mitigation strategies are. This book is organized into three sections. The first section examines the sources of potential contamination. This includes considering the current scenario of heavy metal and pesticide contamination in water as well as the regions impacted due to industrialization, mining, or urbanization. The second section goes on to discuss water contamination and health risks caused by toxic elements, radiological contaminants, microplastics and nanoparticles, and pharmaceutical and personal care products. This book concludes with a section exploring efficient low-cost treatment technologies and remediation strategies that remove toxic pollutants from water. Contamination of Water incorporates both theoretical and practical information that will be useful for researchers, professors, graduate students, and professionals working on water contamination, environmental and health impacts, and the management and treatment of water resources.

The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching.