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.

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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.

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.

Advances in Parasitology, Volume 114, the latest release in this ongoing series, includes medical studies of parasites of major influence, along with reviews of more traditional areas, such as zoology, taxonomy and life history. Chapters in this update include Global Health Governance and the World Health Organization during COVID-19: Current and future impact on control of parasitic diseases towards WHO 2030 targets, Combatting Anthelmintic Resistance in Ruminants, New insights into the Cryptosporidium and cryptosporidiosis in human health and beyond, Control And Elimination Of Lymphatic Filariasis In Oceania: Prevalence, Geographical Distribution, Mass Drug Administration, and Surveillance In Samoa, 1998 To 2017.

International Review of Research in Developmental Disabilities, Volume 60 highlights new advances in the field, with this new volume presenting interesting chapters written by an international board of authors, including updates on School-based Executive Function Interventions Reduce Caregiver Strain, Emergence of Fine Motor Skills in Down Syndrome, Capturing Positive Psychology in People with Intellectual and Developmental Disabilities: A Systematic Review of Constructs and Measures, Navigating with Blurry Maps: School Principals and Special Education Legal Knowledge, Statistical Techniques for Dealing with Small Samples in IDD Research, and more.

Plasmodium Knowlesi, Volume 113 in the Advances in Parasitology series, includes medical studies of parasites of major influence, along with reviews of more traditional areas, such as zoology, taxonomy and life history. Chapters in this update include Taking the strain out of onchocerciasis: a reanalysis of blindness and transmission data does not support the existence of a savanna blinding strain of onchocerciasis in West Africa, Enterocytozoon bieneusi of animals, Taenia solium taeniasis/cysticercosis, Genomic analysis reveals predominant clonality and progressive evolution at all evolutionary scales in eukaryotic pathogens, HTLV-I and Strongyloides: the worm lurking beneath, and more.