Development and Formulation of Veterinary Dosage Forms, Second Edition

Author: Gregory E. Hardee,J. Desmond Baggo

Publisher: CRC Press

ISBN: 9781420001860

Category: Medical

Page: 504

View: 3720

This up-to-the-minute Second Edition of an incomparable resource describes in detail the bases for developing dosage forms for use in animals-highlighting the data necessary to meet regulatory approval. Demonstrates the successful characterization, control, and registration of new veterinary medicines! Thoroughly rewritten and enlarged to reflect the technical advances that have occurred since the previous edition, Development and Formulation of Veterinary Dosage Forms, Second Edition discusses the reasons for dosage form selection explains the latest available technologies examines new drug therapeutics reveals up-to-date techniques and applications for pharmacokinetic data covers the formulation of products derived from biotechnology elucidates recent analytical methods shows how to determine the type of dosage form appropriate for particular species and more! Written by a team of international authorities from North America and Europe and containing over 1100 bibliographic citation, figures, and tables, Development and Formulation of Veterinary Dosage Forms, Second Edition is an essential reference for pharmaceutical, animal, and quality control scientists; research pharmacists and pharmacologists; veterinarians; drug quality assurance and regulatory personnel in government and industry; pathologists; microbiologists; virologists; physiologists; toxicologists; and upper-level undergraduate and graduate students in these disciplines.
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Oral Formulation Roadmap from Early Drug Discovery to Development

Author: Elizabeth Kwong

Publisher: John Wiley & Sons

ISBN: 1118907906

Category: Medical

Page: 272

View: 2991

Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing
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ADMET for Medicinal Chemists

A Practical Guide

Author: Katya Tsaioun,Steven A. Kates

Publisher: John Wiley & Sons

ISBN: 9780470922811

Category: Medical

Page: 512

View: 8612

This book guides medicinal chemists in how to implement early ADMET testing in their workflow in order to improve both the speed and efficiency of their efforts. Although many pharmaceutical companies have dedicated groups directly interfacing with drug discovery, the scientific principles and strategies are practiced in a variety of different ways. This book answers the need to regularize the drug discovery interface; it defines and reviews the field of ADME for medicinal chemists. In addition, the scientific principles and the tools utilized by ADME scientists in a discovery setting, as applied to medicinal chemistry and structure modification to improve drug-like properties of drug candidates, are examined.
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Mechanisms of Transdermal Drug Delivery

Author: Russel O. Potts

Publisher: CRC Press

ISBN: 9781420002249

Category: Medical

Page: 376

View: 7192

Provides an up-to-date and critical examination of biophysical techniques used in the analysis of molecular mechanisms underlying transdermal drug delivery as well as a physical and chemical evaluation of the stratum corneum necessary for the enhancement of percutaneous drug transport. Reflects the hands-on experience of established and novel researchers in the field.
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Bentley's Textbook of Pharmaceutics - E-Book

Author: Sanjay Kumar Jain,Vandana Soni

Publisher: Elsevier Health Sciences

ISBN: 8131232662

Category: Medical

Page: 776

View: 8953

This adaptation of Bentley's Textbook of Pharmaceutics follows the same goals as those of the previous edition, albeit in a new look. The content of the old edition has been updated and expanded and several new chapters, viz. Complexations, Stability Testing as per ICH Guidelines, Parenteral Formulations, New Drug Delivery Systems and Pilot Plant Manufacturing, have been included, with an intention to make the book more informative for the modern pharmacists. The book has six sections: Section I deals with the physicochemical principles. Two new chapters: Complexations and ICH Guidelines for Stability Testing, have been added to make it more informative. Section II conveys the information regarding pharmaceutical unit operations and processes. Section III describes the area of pharmaceutical practice. Extensive recent updates have been included in many chapters of this section. Two new chapters: Parenteral Formulations and New Drug Delivery Systems, have been added. Section IV contains radioactivity principles and applications. Section V deals with microbiology and animal products. Section VI contains the formulation and packaging aspects of pharmaceuticals. Pilot Plant Manufacturing concepts are added as a new chapter, which may be beneficial to readers to understand the art of designing of a plant from the pilot plant model.
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Pharmaceutical Preformulation and Formulation

A Practical Guide from Candidate Drug Selection to Commercial Dosage Form

Author: Mark Gibson

Publisher: CRC Press

ISBN: 9781420073171

Category: Medical

Page: 560

View: 8233

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.
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Pharmaceutical Process Validation, Second Edition

Author: Ira R. Berry,Robert A. Nash

Publisher: CRC Press

ISBN: 9780824787776

Category: Science

Page: 648

View: 5970

An aid for scientists and technicians in the pharmaceutical and allied industries, in the selection of procedures and approaches that may be employed to achieve a successful outcome with respect to product performance and process validation. The present edition brings readers up to date on what has happened in the eight years since publication of the first edition, with the number of chapters nearly doubled to reflect growing interest in topics not previously covered, such as validation of water systems, cleaning validation, computer systems validation, and equipment validation. Several special topics have also been added, including validation of lyophilized products, validation of inhalation aerosols, and recent trends in process validation. Annotation copyright by Book News, Inc., Portland, OR
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Freeze-drying/lyophilization of Pharmaceutical and Biological Products

Author: Louis Rey,Joan Christine May

Publisher: Marcel Dekker Incorporated

ISBN: 9780824719838

Category: Medical

Page: 477

View: 7795

Highlights the application of freeze-drying to pharmaceuticals-illustrating practical & industry-tested methods of preserving & reactivating delicate biologicals & biochemicals. Discusses the basic principles & engineering aspects of lyophilization, & also the role of bulking agents, additives, cryoprotectants, antioxidants, free radicals, & other products that protect the biological integrity of active substances during freezing, drying, & storage.
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Pharmaceutical Statistics Practical And Clinical Applications, Third Edition

Author: Bolton Sanford

Publisher: CRC Press

ISBN: 9780824798123

Category: Medical

Page: 768

View: 4917

This edition offers new and expanded information on recent developments in stability data analysis, concepts of statistical outliners, bioequivalence studies, problems in sampling and devising limits for product release, covariance analysis and tolerance intervals, multiple endpoints and clinical data analysis, and more. student price which is available upon request from Marcel Dekker.
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Drug Stability

Principles and Practices

Author: Jens Thurø Carstensen

Publisher: Marcel Dekker

ISBN: N.A

Category: Drug stability

Page: 601

View: 9832

This work combines basic theory, current industrial practice and useful regulatory aspects in an overview of pharmaceutical stability. It examines data analysis of packaged drug's stability, experimental methods for achieving stable marketed products and the stability principles of drugs in dissolved, dispersed and solid states. This second edition: presents new information on the effect micro-environmental pH has on the stability and behaviour of solid-drug substances; discusses the advantages and limitations of harmonization; features updated coverage of computer programs for determining the stability function; and more.
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Modern Pharmaceutics

Author: Gilbert S. Banker,Christopher T. Rhodes

Publisher: CRC Press

ISBN: N.A

Category: Medical

Page: 943

View: 6549

An up-to-date, sequenced approach to drug dosage formulation, design and evaluation. This edition offers new chapters on regulatory aspects of the pharmaceutical industry in the European Union, the pharmaceutical needs of special populations, target-oriented drug delivery systems and more.
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Pharmaceutical Inhalation Aerosol Technology

Author: Anthony J. Hickey

Publisher: Marcel Dekker Incorporated

ISBN: 9780824784645

Category: Medical

Page: 365

View: 9751

This thoroughly revised and expanded reference provides authoritative discussions on the physiologic, pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosol. It analyzes the latest science and developments in the generation, administration and characterization of these compounds, showcasing current clinical applications, the efficiency and limitations of major aerosol products and emerging aerosol therapies impacting the field.
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Good Manufacturing Practices for Pharmaceuticals

A Plan for Total Quality Control

Author: Sidney H. Willig,James R. Stoker

Publisher: N.A

ISBN: 9780824797706

Category: Drug industry

Page: 496

View: 6191

Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.
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Scale-up

Modellübertragung in der Verfahrenstechnik

Author: Marko Zlokarnik

Publisher: John Wiley & Sons

ISBN: 3527660461

Category: Science

Page: 295

View: 817

Die Übertagung von Verfahren aus dem Labor-bzw. dem Techni-kumsmaßstab in den industriellen maßstab einer Produktiosanlage ist eine der wichtigsten ingenieurstechnischen Aufgaben in der chemischen Industrie. Die einzige zuverlässige Methode dazu basiert auf der Darstellung von Versuchsergebnissen im zutreffenden dimensions-analytischen Raum, der sich als maßstabsinvariant erweist. Das Buch ist in zwei Teile gegliedert: In der ersten Hälfte werden die vertiefte mathematische Vorkenntnisse dieses Themengebiet näherzubringen. Diskutiert werden die Grundlagen der Dimensionsanalyse, die Behandlung von temperaturabhängigen und von rheologischen Stoffwerten und die Modellübertragung bei Nichtverfügbarkeit von Modellstoffsystemen, sowie bei partieller Ähnlichkeit/ All dies wird dem leser anhand von 20 modernen Beispielen aus der heutigen verfahrenstechnischcen Praxis illustriert, der sich mit 25 in dieser Auflage neu hinzugekommenen Übungsaufgaben sein Verständnis aktive erarbeiten und anhand der Lösungen kontrollieren kann. Im zweitem Teil des Buches werden die einzelnen verfahrenstechnischen Grundoperationen aus den Bereichen mechanische, thermische und chemische Verfahrenstechnik aus der Sicht der Dimensionsanalyse und der Modellübertragung beispielhaft behandelt, und es werden für jede Operation die Maßstabsübertragungsregeln vorgestellt und diskutiert. Das vorliegende Buch wendet sich dementsprechend an Studenten wie auch bereits auf dem gebiet tätige Ingenieure, Chemiker und Verfahrenstechniker.
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