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Biosimilar Drug Product Development
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Good Design Practices for GMP Pharmaceutical Facilities
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Handbook of Bioequivalence Testing, Second Edition
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 made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmac...
Pharmaceutical Extrusion Technology
The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields
Active Pharmaceutical Ingredients
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
Encyclopedia of Pharmacy Practice and Clinical Pharmacy
Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical ...
Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms
Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific a...
Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition
The most comprehensive text on the practical applications of biopharmaceuticals and pharmacokinetics! 4 STAR DOODY'S REVIEW! "The updated edition provides the reader with a solid foundation in the basic principles of pharmacokinetics and biopharmaceutics. Students will be able to apply the information to their clinical practice and researchers will find this to be a valuable reference. This modestly priced book should be the gold standard for student use."--Doody's Review Service The primary emphasis of this book is on the application and understanding of concepts. Basic theoretical discussions of the principles of biopharmaceutics and pharmacokinetics are provided, along with illustrative examples and practice problems and solutions to help the student gain skill in practical problem solving.
Applied Biopharmaceutics & Pharmacokinetics, Sixth Edition
A comprehensive textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics The field’s leading text for more than three decades Applied Biopharmaceutics & Pharmacokinetics, Sixth Edition provides you with a basic understanding of the principles of biopharmaceutics and pharmacokinetics and applies these principles to drug product development, drug product performance and drug therapy. The revised and updated sixth edition is unique in teaching basic concepts that relate to understanding the complex issues associated with safe and efficacious drug therapy. Written by authors who have both academic and clinical experience, Applied Biopharmaceutics & Pharma...
Applied Biopharmaceutics & Pharmacokinetics, Eigth Edition
Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. This authoritative guide has been updated with important new findings about drug therapy, product performance, and other need-to-know topics Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition delivers the knowledge and skills you need to succeed. The authors provide practical problems with specific examples of clinical solutions to help you apply principles to patient care and drug consultation situations. Each chapter includes objectives, summaries, and FAQs highlighting that help you understand and retain key concepts. You’ll learn how to derive models/parameters to describe drug absorption, distribution, and elimination processes; evaluate biopharmaceutic studies involving drug product equivalency and unequivalency; design and evaluate dosage regimens of drugs; detect and solve clinical pharmacokinetic problems; and much more.
