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Books in Pharmaceutical science

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Fundamentals of Biologicals Regulation

  • 2nd Edition
  • July 1, 2025
  • Rebecca Sheets + 6 more
  • English
  • Paperback
    9 7 8 - 0 - 4 4 3 - 2 1 9 8 8 - 7
  • eBook
    9 7 8 - 0 - 4 4 3 - 2 1 9 8 9 - 4
Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. In this new edition the book provides more in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans and REMS, and switching from reliance on in vivo to in vitro analytical methods. This new edition also reflects the new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes for students. This book provides multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions with emphasis on the European Medicines Agency and the U.S. Food and Drug Administration. Graduate students will benefit from the new pedagogic features. Regulatory professionals will have in Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines a complete guide to navigate through the approval process.

An Overview of FDA Regulated Products

  • 2nd Edition
  • April 1, 2025
  • Eunjoo Pacifici + 1 more
  • English
  • Paperback
    9 7 8 - 0 - 4 4 3 - 2 3 7 8 0 - 5
  • eBook
    9 7 8 - 0 - 4 4 3 - 2 3 7 8 1 - 2
An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition is fully updated to reflect recent advances in science and technology and new laws and regulations. Breakthroughs in cellular and gene therapy, immunotherapy, precision medicine, and digital health are changing the face of healthcare and regulation. The updates brought about by the 21st Century Cures Act and subsequent PDUFA Reauthorizations, as well as signing into law the “Modernization of Cosmetic Regulation Act of 2022,” which will transform FDA’s oversight of cosmetics, are fully reflected in all chapters of the book.This book provides graduate students and industry professionals with comprehensive information on approval processes with the FDA and other country regulation organizations. Regulatory science professionals working with not only drugs, but biologics, medical devices, food and additives, cosmetics, veterinary products, and tobacco will benefit from this comprehensive overview of the regulatory environment.

Reproducibility in Biomedical Research

  • 2nd Edition
  • April 26, 2024
  • Erwin B. Montgomery Jr.
  • English
  • Paperback
    9 7 8 - 0 - 4 4 3 - 1 3 8 2 9 - 4
  • eBook
    9 7 8 - 0 - 4 4 3 - 1 3 8 3 0 - 0
Reproducibility in Biomedical Research: Epistemological and Statistical Problems, Second Edition explores the ideas and conundrums inherent in scientific research. This second edition addresses new challenges to reproducibility in biosciences, namely reproducibility of machine learning Artificial Intelligence (AI), reproducibility of translation from research to medical care, and the fundamental challenges to reproducibility. All current chapters are expanded to cover advances in the topics previously addressed. This book provides biomedical researchers with a framework to better understand the reproducibility challenges in the area. Newly introduced interactive exercises and updated case studies help students understand the fundamental concepts involved in the area.

Dosage Forms, Formulation Developments and Regulations

  • 1st Edition
  • December 4, 2023
  • Amit Kumar Nayak + 1 more
  • English
  • Paperback
    9 7 8 - 0 - 3 2 3 - 9 1 8 1 7 - 6
  • eBook
    9 7 8 - 0 - 3 2 3 - 9 7 2 4 6 - 8
Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics.

From Current to Future Trends in Pharmaceutical Technology

  • 1st Edition
  • November 30, 2023
  • Natassa Pippa + 2 more
  • English
  • Paperback
    9 7 8 - 0 - 3 2 3 - 9 1 1 1 1 - 5
  • eBook
    9 7 8 - 0 - 3 2 3 - 9 1 4 3 9 - 0
From Current to Future Trends in Pharmaceutical Technology explores the current trends of this field and creates a multi-aspect framework for the reader. The book covers topics on pharmaceutics, pharmaceutical engineering, pre-formulation protocols, techniques, innovative excipients, bio-printing techniques, scale-up based on formulas on-a-chip, and regulatory aspects based on new scientific achievements. Modified dosage forms, new aspects on the compatibility of drug excipients interactions, and drug release by various dosage forms are included. Physical pharmacy (physical and biological stability of dosage forms), innovative excipients, patents on innovative formulations and regulatory issues related to the approval process of medicines are also discussed. The book is a valuable resource for a wide audience of academics, industrial researchers and professionals working in this field as the development of efficient and safe medicines is critical to future needs.

Pharmaceutical Care in Digital Revolution

  • 2nd Edition
  • August 18, 2023
  • Ardalan Mirzaei + 1 more
  • English
  • Paperback
    9 7 8 - 0 - 4 4 3 - 1 3 3 6 0 - 2
  • eBook
    9 7 8 - 0 - 4 4 3 - 1 3 3 6 1 - 9
Pharmaceutical Care in the Digital Revolution: Blending Digital with Human Innovation, Second Edition provides readers with an updated view on how to use technology to improve pharmaceutical care (PC) and enhance drug outcomes with digital tools. Organized into four parts, including Global Healthcare Systems Under Pressure, Digital Advances to Innovate Pharmaceutical Care Journeys, Conditions to Drive Combinatoric Pharma-Digital Innovation, and What to do Tomorrow as a Pharmaceutical Care Leader, the book further examines digital developments that will optimize the PC process and prepare stakeholders for a dynamic future that will optimize the life of patients against a sustainable cost model. This edition also discusses recent advances in the digital health arena that will change the way we approach healthcare and prevention while also providing interactive links to lectures and technologies, tutorials on how to implement advances in your own working environment, and examples of pharmacists who are successful in building synergy between digital and pharma.

Surfactants in Biopharmaceutical Development

  • 1st Edition
  • August 12, 2023
  • Atanas V. Koulov + 1 more
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 1 2 5 0 3 - 8
  • eBook
    9 7 8 - 0 - 1 2 - 8 1 2 5 6 9 - 4
Surfactants in Biopharmaceutical Development addresses the progress, challenges, and opportunities in surfactant research in the context of the development of biologic therapeutics. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses, which is the reason that nearly all therapeutic proteins in development and on the market today contain surfactants. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients for biopharmaceuticals by the industry and by regulators.This book provides a broad range of important surfactant-related topics as they relate directly to biopharmaceutical development. The initial chapters of the book address fundamental topics, like synthesis of surfactants, mechanisms of protein stabilization by surfactants, as well as practical considerations for the use of surfactants in biomanufacturing. Later chapters provide overview of the state-of-the-art analytical technology and methods for quantification and characterization of surfactants, as well as a deep-dive in one of the hottest topics in biopharmaceutical development today – surfactant degradation and its impact to drug product quality and stability. The book concludes with forward-looking chapters on control strategies with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators.

Phytonutrients and Neurological Disorders

  • 1st Edition
  • July 1, 2023
  • Haroon Khan + 2 more
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 2 4 4 6 7 - 8
  • eBook
    9 7 8 - 0 - 3 2 3 - 8 5 9 7 8 - 3
Phytonutrients and Neurological Disorders: Therapeutic and Toxicological Aspects provides and assesses the latest research and developments surrounding the use of phytonutrients for the treatment of neurological disorders. The volume analyzes advances in phytonutrient isolation, characterization and therapeutic applications, giving particular emphasis to mechanisms and safety profiles. The book takes toxicological considerations into account, including adverse drug reactions, toxicokinetics and toxicodynamics. Sections cover bioactive compound classes and biosynthesis pathways, general considerations, including quality control, standardization, and technology, and toxicology. This title is a comprehensive work on the latest research in phytonutrients and neurological disorders that will be useful to researchers and medical practitioners.

Overcoming Obstacles in Drug Discovery and Development

  • 1st Edition
  • May 18, 2023
  • Kan He + 2 more
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 1 7 1 3 4 - 9
  • eBook
    9 7 8 - 0 - 1 2 - 8 1 7 3 3 9 - 8
Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development.

Managing the Drug Discovery Process

  • 2nd Edition
  • March 9, 2023
  • Susan Miller + 5 more
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 2 4 3 0 4 - 6
  • eBook
    9 7 8 - 0 - 1 2 - 8 2 4 3 0 5 - 3
Managing the Drug Discovery Process, Second Edition thoroughly examines the current state of pharmaceutical research and development by providing experienced perspectives on biomedical research, drug hunting and innovation, including the requisite educational paths that enable students to chart a career path in this field. The book also considers the interplay of stakeholders, consumers, and drug firms with respect to a myriad of factors. Since drug research can be a high-risk, high-payoff industry, it is important to students and researchers to understand how to effectively and strategically manage both their careers and the drug discovery process. This new edition takes a closer look at the challenges and opportunities for new medicines and examines not only the current research milieu that will deliver novel therapies, but also how the latest discoveries can be deployed to ensure a robust healthcare and pharmacoeconomic future. All chapters have been revised and expanded with new discussions on remarkable advances including CRISPR and the latest gene therapies, RNA-based technologies being deployed as vaccines as well as therapeutics, checkpoint inhibitors and CAR-T approaches that cure cancer, diagnostics and medical devices, entrepreneurship, and AI. Written in an engaging manner and including memorable insights, this book is aimed at anyone interested in helping to save countless more lives through science. A valuable and compelling resource, this is a must-read for all students, educators, practitioners, and researchers at large—indeed, anyone who touches this critical sphere of global impact—in and around academia and the biotechnology/pharmaceutical industry.