Sample Preparation of Pharmaceutical Dosage Forms PDF Download
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Author: Beverly Nickerson
Publisher: Springer Science & Business Media
ISBN: 1441996311
Category : Medical
Languages : en
Pages : 400
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Book Description
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.
Author: Beverly Nickerson
Publisher: Springer Science & Business Media
ISBN: 1441996311
Category : Medical
Languages : en
Pages : 400
Get Book Here
Book Description
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.
Author:
Publisher: Academic Press
ISBN: 012814422X
Category : Medical
Languages : en
Pages : 816
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Book Description
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. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Author: Jack Zheng
Publisher: John Wiley & Sons
ISBN: 0470056096
Category : Medical
Languages : en
Pages : 506
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Book Description
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.
Author:
Publisher: Academic Press
ISBN: 0128144246
Category : Medical
Languages : en
Pages : 881
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Book Description
Dosage Form Design Parameters, Volume I, 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. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Author: P. Heinrich Stahl
Publisher: John Wiley & Sons
ISBN: 9783906390581
Category : Medical
Languages : en
Pages : 392
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Book Description
This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.
Author: Howard C. Ansel
Publisher: Lippincott Williams & Wilkins
ISBN: 9780683305722
Category : Drug delivery systems
Languages : en
Pages : 0
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Book Description
This work covers the entire scope of pharmaceutics, from the basics of drug dosage and routes of administration to the finer points of drug discovery, drug product development, legislation and regulations governing quality standards and product approval for marketing.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241544184
Category : Medical
Languages : en
Pages : 144
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Book Description
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080455182
Category : Medical
Languages : en
Pages : 679
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Book Description
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Author: Georg Hempel
Publisher: Elsevier
ISBN: 0444640673
Category : Science
Languages : en
Pages : 382
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Book Description
Methods of Therapeutic Drug Monitoring Including Pharmacogenetics, Second Edition, Volume Seven in the Handbook of Analytical Separations series, covers all aspects of drug monitoring, including laboratory work, pharmacokinetic analysis and clinical aspects, thus enabling readers from different fields to understand the whole process of therapeutic drug monitoring and how to avoid common pitfalls. The book contains analytical techniques for the quantification of drugs, along with pharmacogenetic and pharmacogenomic methods. Also included are updates on sample preparation, including dried blood spot technology and microextraction methods. In addition, the book includes new drugs, such as tyrosine kinase inhibitors and the monitoring of immunosuppressant drugs. - Presents a unique, interdisciplinary approach that appeals to a wide range of users - Written by authors from international labs, providing a global perspective that can be applied in various regulatory environments - Features additional therapeutic drugs to reflect the rising number of immunocompromised patients - Includes a new mass spectroscopic methods chapter to capture the frequent use in TDM and the improved availability of LC-MS across laboratories
Author: David S. Jones
Publisher: Pharmaceutical Press
ISBN: 0857110780
Category : Medical
Languages : en
Pages : 433
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Book Description
FASTtrack Pharmaceutics – Dosage Form and Design focuses on what you really need to know in order to pass your pharmacy exams. It provides concise, bulleted information, key points, tips and an all-important self-assessment section, including MCQs.
