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Formulation And Analytical Development For Low Dose Oral Drug Products

Author: Jack Zheng
Publisher: John Wiley & Sons
ISBN: 9780470386354
Size: 42.60 MB
Format: PDF, ePub, Mobi
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There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Developing Drug Products In An Aging Society

Author: Sven Stegemann
Publisher: Springer
ISBN: 3319430998
Size: 13.40 MB
Format: PDF, ePub, Mobi
View: 1073
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This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Continuous Manufacturing Of Pharmaceuticals

Author: Peter Kleinebudde
Publisher: John Wiley & Sons
ISBN: 1119001358
Size: 13.36 MB
Format: PDF, Kindle
View: 449
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A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Drug And Biological Development

Author: Ronald Evens
Publisher: Springer Science & Business Media
ISBN: 0387329781
Size: 62.99 MB
Format: PDF
View: 501
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The book is a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, and through life cycle management. Format is optimized for education and training of health care professionals, especially fellows in training (MD, PharmD, PhD), at universities. Format of the book is a set of figures, tables and lists, that can become power-point style slides as well, and the detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. Industry and research experts (multidisciplinary ' MD, PharmD, and PhD) are editors and authors. An added CD-ROM (slides only) enhances utility and marketability of book to course directors, providing the highly sought after slides for lectures.

Generic Drug Product Development

Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086359
Size: 20.79 MB
Format: PDF, ePub, Mobi
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In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

Generic Drug Product Development

Author: Isadore Kanfer
Publisher: CRC Press
ISBN:
Size: 68.57 MB
Format: PDF
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The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

Applied Biopharmaceutics Pharmacokinetics Sixth Edition

Author: Leon Shargel
Publisher: McGraw Hill Professional
ISBN: 0071603948
Size: 17.35 MB
Format: PDF, ePub, Mobi
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A comprehensive textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics The field’s leading text for more than three decades Applied Biopharmaceutics & Pharmacokinetics, Sixth Edition provides you with a basic understanding of the principles of biopharmaceutics and pharmacokinetics and applies these principles to drug product development, drug product performance and drug therapy. The revised and updated sixth edition is unique in teaching basic concepts that relate to understanding the complex issues associated with safe and efficacious drug therapy. Written by authors who have both academic and clinical experience, Applied Biopharmaceutics & Pharmacokinetics will help you to: Understand the basic concepts in biopharmaceutics and pharmacokinetics. Use raw data and derive the pharmacokinetic models and parameters that best describe the process of drug absorption, distribution, and elimination Critically evaluate biopharmaceutic studies involving drug product equivalency and unequivalency Design and evaluate dosage regimens of drugs, using pharmacokinetic and biopharmaceutic parameters Detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them Practical problems and clinical examples with discussions are included in each chapter to help you apply these principles to patient care and drug consultation situations. Chapter Objectives, Chapter Summaries, and Frequently Asked Questions along with additional application questions appear within each chapter to identify and focus on key concepts. Most of the chapters have been revised to reflect our current understanding of drug product performance, bioavailability, bioequivalence, pharmacokinetics, pharmacodynamics, and drug therapy.

Applied Biopharmaceutics Pharmacokinetics Seventh Edition

Author: Leon Shargel
Publisher: McGraw Hill Professional
ISBN: 0071829644
Size: 38.44 MB
Format: PDF, ePub, Mobi
View: 2743
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The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics—now fully updated. Explains how to detect clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them Helps you critically evaluate biopharmaceutic studies involving drug product equivalency and unequivalency Chapters have been revised to reflect the latest clinical perspectives on drug performance, bioavailability, bioequivalence, pharmacokinetics, pharmacodynamics, and drug therapy The field’s leading text for more than three decades, Applied Biopharmaceutics & Pharmacokinetics gets you up to speed on the basics of the discipline like no other resource. Practical problems and clinical examples with discussions are integrated within each chapter to help you apply principles to patient care and drug consultation situations. In addition, outstanding pedagogy, including chapter objectives, chapter summaries, and FAQs, plus additional application questions, identify and focus on key concepts. Written by authors who have both academic and clinical experience, Applied Biopharmaceutics & Pharmacokinetics shows you how to use raw data and formulate the pharmacokinetic models and parameters that best describe the process of drug absorption, distribution, and elimination. The book also helps you work with pharmacokinetic and biopharmaceutic parameters to design and evaluate dosage regimens of drugs. In the seventh edition of this must-have interactive learning tool, most of the chapters are updated to reflect our current understanding of complex issues associated with safe and efficacious drug therapy.

Poorly Soluble Drugs

Author: Gregory K. Webster
Publisher: CRC Press
ISBN: 1315340860
Size: 59.32 MB
Format: PDF, Mobi
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This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.