Developing Solid Oral Dosage Forms

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Release : 2009-03-10
Genre : Medical
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Book Rating : 72X/5 ( reviews)

Developing Solid Oral Dosage Forms - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Developing Solid Oral Dosage Forms write by Yihong Qiu. This book was released on 2009-03-10. Developing Solid Oral Dosage Forms available in PDF, EPUB and Kindle. Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

How to Develop Robust Solid Oral Dosage Forms

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Release : 2016-10-05
Genre : Medical
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Book Rating : 321/5 ( reviews)

How to Develop Robust Solid Oral Dosage Forms - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook How to Develop Robust Solid Oral Dosage Forms write by Bhavishya Mittal. This book was released on 2016-10-05. How to Develop Robust Solid Oral Dosage Forms available in PDF, EPUB and Kindle. How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Pharmaceutical Excipients

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Release : 2016-10-03
Genre : Medical
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Book Rating : 423/5 ( reviews)

Pharmaceutical Excipients - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Pharmaceutical Excipients write by Otilia M. Y. Koo. This book was released on 2016-10-03. Pharmaceutical Excipients available in PDF, EPUB and Kindle. This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Generic Drug Product Development

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Release : 2013-10-24
Genre : Medical
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Book Rating : 367/5 ( reviews)

Generic Drug Product Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Generic Drug Product Development write by Leon Shargel. This book was released on 2013-10-24. Generic Drug Product Development available in PDF, EPUB and Kindle. 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

Sample Preparation of Pharmaceutical Dosage Forms

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Release : 2011-08-05
Genre : Medical
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Book Rating : 311/5 ( reviews)

Sample Preparation of Pharmaceutical Dosage Forms - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Sample Preparation of Pharmaceutical Dosage Forms write by Beverly Nickerson. This book was released on 2011-08-05. Sample Preparation of Pharmaceutical Dosage Forms available in PDF, EPUB and Kindle. This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.