Books in Pharmaceutical science general

Providing a broad overview of drug discovery, development, and regulation, this collection supports researchers, educators, and industry professionals. It features foundational principles, emerging trends, and interdisciplinary approaches that underpin innovation in pharmaceutical sciences.

Advanced Issue Resolution in Safety Pharmacology
1st Edition
Mary Jeanne Kallman + 1 more
English
Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.
Dosage Form Design Parameters
Volume II
1st Edition
English
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.
Accelerated Predictive Stability (APS)
Fundamentals and Pharmaceutical Industry Practices
1st Edition
Fenghe Qiu + 1 more
English
Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly.
Diagnostic and Therapeutic Applications of Exosomes in Cancer
1st Edition
Mansoor M. Amiji + 1 more
English
Diagnostic and Therapeutic Applications of Exosomes in Cancer evaluates the potential of exosome content manipulation in the development of novel therapeutics. In recent years, exosomes, the small vesicles produced by all cell types, have been identified as contributors to cancer growth and metastasis. However, due to their unique biophysical properties, they are also being tested for use in therapeutic design and delivery, as well as in diagnostics. This book presents a comprehensive analysis on exosomes, with a main emphasis on their biogenesis and signaling, use as biomarkers, and as tools for imaging, drug delivery and the treatment of cancer.
Multivariate Analysis in the Pharmaceutical Industry
1st Edition
Ana Patricia Ferreira + 2 more
English
Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators.
Nanotechnology-Based Targeted Drug Delivery Systems for Brain Tumors
1st Edition
Prashant Kesharwani + 1 more
English
Nanotechnology-Based Targeted Drug Delivery Systems for Brain Tumors addresses brain anatomy and tumors and the progress and challenges in delivering drugs across the blood brain barrier. Several chapters are devoted to the latest technologies and advances in nanotechnology, along with practical solutions on how to design more effective nanocarriers for drug and gene delivery. This valuable resource prepares readers to develop novel drug delivery systems for the treatment of brain tumors that further promote the latest nanomedical technologies.
FDA's Drug Review Process and the Package Label
Strategies for Writing Successful FDA Submissions
1st Edition
Tom Brody
English
FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.
Inhaled Pharmaceutical Product Development Perspectives
Challenges and Opportunities
1st Edition
Anthony J. Hickey
English
Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future.
Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries
Present Challenges and Future Solutions
1st Edition
Mohamed Izham Mohamed Ibrahim + 2 more
English
Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries: Present Challenges and Future Solutions examines the particularities of low- and middle-income countries and offers solutions based on their needs, culture and available resources. Drawing from the firsthand experience of researchers and practitioners working in these countries, this book addresses the socio-behavioral aspects of pharmacy and health, pharmacoeconomics, pharmaceutical policy, supply management and marketing, pharmacoepidemiology and public health pharmacy specific to low- and middle-income countries. While some practices may be applied appropriately in disparate places, too often pharmacy practice in low- and middle-income countries is directly copied from successes in developed countries, despite the unique needs and challenges low- and middle-income countries face.
An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology
1st Edition
Padma Nambisan
English
An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology provides a comprehensive look at the biggest technologies that have revolutionized biology since the early 20th century, also discussing their impact on society. The book focuses on issues related to bioethics, biosafety and intellectual property rights, and is written in an easy-to-understand manner for graduate students and early career researchers interested in the opportunities and challenges associated with advances in biotechnology. Important topics covered include the Human Genome Project, human cloning, rDNA technology, the 3Rs and animal welfare, bioterrorism, human rights and genetic discrimination, good laboratory practices, good manufacturing practices, the protection of biological material and much more. Full of relevant case studies, practical examples, weblinks and resources for further reading, this book offers an essential and holistic look at the ways in which biotechnology has affected our global society.