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.

Handbook of Opium: History and Basis of Opioids in Therapeutics traces the history of poppy from its prehistory, its use in Greek and Egyptian medicine through the European Renaissance, and the opioid epidemic of the present day. The book explores the discovery of morphine and its alkaloids, reviews its biosynthetic process, and covers the evolution of synthetic opioids. Further, it reviews the biological effects of opium and the molecular basis of its actions, including future perspectives in clinical applications with therapeutic targets. The book is interspersed with numerous notes on the events and great minds in history and medicine who advocated, analyzed and advanced opium through history. The book is a comprehensive review on opium, covering a breadth of topics, including its history, botany, chemistry, trade, physiology, clinical use and molecular biology, with numerous references, tables, vignettes and illustrations included for additional understanding.

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.

Tamoxifen Tales: Suggestions for Scientific Survival presents a case study describing the academic journey of teams behind major advances in medical sciences, highlighting lessons learned that are applicable to the next generation of scientists. This book provides a manual on the successful mentoring of young scientists, including stories describing how training experience shaped careers to become leaders in academia and the pharmaceutical industry. The book documents Professor V. Craig Jordan's 50-year career in medical sciences that led to the discovery and development of Selective Estrogen Receptor Modulators (SERMs), which became the standard of women's healthcare around the world. Additionally, it illustrates the versatility of a scientist with a commitment to serving societies. This important resource will be a useful and interesting book for established medical scientists, research mentors and advanced students wanting to chart a successful and impactful research career.

Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists.