Books in Pharmaceutical science general

Biocontamination Control for Pharmaceuticals and Healthcare

1st Edition
November 30, 2018
Tim Sandle
English
Paperback
9 7 8 0 1 2 8 1 4 9 1 1 9
eBook
9 7 8 0 1 2 8 1 4 9 1 2 6

Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.

New Look to Phytomedicine

1st Edition
October 23, 2018
Mohd Sajjad Ahmad Khan + 2 more
English
Paperback
9 7 8 0 1 2 8 1 4 6 1 9 4
eBook
9 7 8 0 1 2 8 1 4 6 2 0 0

New Look to Phytomedicine: Advancements in Herbal Products as Novel Drug Leads is a compilation of in-depth information on the phytopharmaceuticals used in modern medicine for the cure and management of difficult-to-treat and challenging diseases. Readers will find cutting-edge knowledge on the use of plant products with scientific validation, along with updates on advanced herbal medicine in pharmacokinetics and drug delivery. This authoritative book is a comprehensive collection of research based, scientific validations of bioactivities of plant products, such as anti-infective, anti-diabetic, anti-cancer, immune-modulatory and metabolic disorders presented by experts from across the globe. Step-by-step information is presented on chemistry, bioactivity and the functional aspects of biologically active compounds. In addition, the pharmacognosy of plant products with mechanistic descriptions of their actions, including pathogenicity is updated with information on the use of nanotechnology and molecular tools in relation to herbal drug research.

Advanced Issue Resolution in Safety Pharmacology

1st Edition
September 5, 2018
Mary Jeanne Kallman + 1 more
English
Hardback
9 7 8 0 1 2 8 1 2 2 0 6 8
eBook
9 7 8 0 1 2 8 1 2 3 3 4 8

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

1st Edition
July 25, 2018
Rakesh Kumar Tekade
English
Hardback
9 7 8 0 1 2 8 1 4 4 2 1 3
eBook
9 7 8 0 1 2 8 1 4 4 2 2 0

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)

1st Edition
May 14, 2018
Fenghe Qiu + 1 more
English
Hardback
9 7 8 0 1 2 8 0 2 7 8 6 8
eBook
9 7 8 0 1 2 8 0 2 7 8 5 1

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
May 9, 2018
Mansoor M. Amiji + 1 more
English
Hardback
9 7 8 0 1 2 8 1 2 7 7 4 2
eBook
9 7 8 0 1 2 8 1 2 8 0 4 6

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
April 24, 2018
Ana Patricia Ferreira + 2 more
English
Paperback
9 7 8 0 1 2 8 1 1 0 6 5 2
eBook
9 7 8 0 1 2 8 1 1 0 6 6 9

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
April 20, 2018
Prashant Kesharwani + 1 more
English
Paperback
9 7 8 0 1 2 8 1 2 2 1 8 1
eBook
9 7 8 0 1 2 8 1 2 2 4 9 5

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

1st Edition
December 1, 2017
Tom Brody
English
Paperback
9 7 8 0 1 2 8 1 4 6 4 7 7
eBook
9 7 8 0 1 2 8 1 4 6 4 8 4

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

1st Edition
November 23, 2017
Anthony J. Hickey
English
Paperback
9 7 8 0 1 2 8 1 2 2 0 9 9
eBook
9 7 8 0 1 2 8 1 2 3 3 6 2

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.

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