Pharmaceutical Photostability And Stabilization Technology

Author: Joseph T. Piechocki
Editor: CRC Press
ISBN: 9781420014136
Size: 15,57 MB
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Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background in the scientific principles involved in photostability testing. Presenting the advantages and disadvantages of various procedures so the reader can select and utilize the most appropriate technique best-suited to their needs, this source includes references to current literature in the field and offers an opinion on future opportunities and challenges.

Pharmaceutical Stress Testing

Author: Steven W. Baertschi
Editor: CRC Press
ISBN: 1439801800
Size: 19,42 MB
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The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

Drug Delivery Nanoparticles Formulation And Characterization

Author: Yashwant Pathak
Editor: CRC Press
ISBN: 1420078054
Size: 19,39 MB
Format: PDF, Kindle
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Exploring fundamental concepts, Drug Delivery Nanoparticles Formulation and Characterization presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval. This comprehensive guide features: Process Analytical Techniques (PAT) used in manufacturing Nanoparticulate Drug Delivery Systems (NPDDS) In-vitro and in-vivo evaluation of NPDDS Applications of novel techniques used in formulation development and characterization, such as microscopic and nonmicroscopic techniques 100 high-quality images

Generic Drug Product Development

Author: Isadore Kanfer
Editor: CRC Press
ISBN: 1420020021
Size: 16,79 MB
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Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Pharmaceutical Statistics

Author: Sanford Bolton
Editor: CRC Press
ISBN: 1420074237
Size: 11,38 MB
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Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.

Polymorphism In Pharmaceutical Solids Second Edition

Author: H. G. Brittain
Editor: CRC Press
ISBN:
Size: 17,17 MB
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Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism and solvatomorphism, while systematically explaining their thermodynamic and structural origins. Topics include: Computational methodologies High-throughput screening methods Pharmaceutical cocrystals Thermally-induced and solution-mediated phase transformations Amorphous solids Crystallography preparation and characterization The amorphous state

The British National Bibliography

Author: Arthur James Wells
Editor:
ISBN:
Size: 11,28 MB
Format: PDF
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Pharmaceutical Suspensions

Author: Alok K. Kulshreshtha
Editor: Springer Science & Business Media
ISBN: 9781441910875
Size: 15,67 MB
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The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.

Handbook Of Stability Testing In Pharmaceutical Development

Author: Kim Huynh-Ba
Editor: Springer Science & Business Media
ISBN: 0387856277
Size: 10,40 MB
Format: PDF
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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.

Freeze Drying Lyophilization Of Pharmaceutical Biological Products Second Edition Revised And Expanded

Author: Louis Rey
Editor: CRC Press
ISBN: 0203021320
Size: 18,92 MB
Format: PDF, ePub
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Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.