Handbook of Dissolution Testing PDF Download
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Author: William A. Hanson
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 180
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Book Description
Author: William A. Hanson
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 180
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Book Description
Author: Royal Hanson
Publisher:
ISBN: 9780976151906
Category : Drugs
Languages : en
Pages : 199
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Book Description
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1482226383
Category : Medical
Languages : en
Pages : 1007
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Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 0849383595
Category : Medical
Languages : en
Pages : 602
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Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made
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: Umesh V. Banakar
Publisher: CRC Press
ISBN: 9780824785673
Category : Medical
Languages : en
Pages : 456
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Book Description
Introduction, Historical Highlights, and the Need for Dissolution Testing Theories of Dissolution Dissolution Testing Devices Automation in Dissolution Testing, by William A. Hanson and Albertha M. Paul Factors That Influence Dissolution Testing Interpretation of Dissolution Rate Data Techniques and of In Vivo Dissolution, by Umesh V. Banakar, Chetan D. Lathia, and John H. Wood Dissolution of Dosage Forms Dissolution of Modified-Release Dosage Forms Dissolution and Bioavailability Dissolution Testing and the Assessment of Bioavailability/Bioequivalence, by Santosh J. Vetticaden Dissolution Rediscovered, by John H. Wood Appendix: USP/NF Dissolution Test.
Author: Jennifer J. Dressman
Publisher: CRC Press
ISBN: 9780824754679
Category : Medical
Languages : en
Pages : 429
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Book Description
An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389
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Book Description
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Author: Gregory K. Webster
Publisher: CRC Press
ISBN: 1315340860
Category : Medical
Languages : en
Pages : 578
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Book Description
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-Ã -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.
Author: Safaraz K. Niazi
Publisher: CRC Press
ISBN: 1420081314
Category : Medical
Languages : en
Pages : 458
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Book Description
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
