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Handbook of Pharmaceutical Manufacturing Formulations Third Edition
"The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this six-volume set compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent"--
Handbook of Bioequivalence Testing
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
Biosimilars and Interchangeable Biologics
What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th
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...
Biosimilars and Interchangeable Biologics
What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordabil...
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
Filing Patents Online
The average cost of an uncomplicated patent application filing is about $10,000. This high cost can leave thousands of inventors out in the cold. Filing Patents Online: A Professional Guide is a complete manual that walks inventors through each step of filing and prosecuting the patent online at a fraction of the cost. The online filing system reco
Antigen Presenting Cells
This novel, multidisciplinary handbook highlights recent evidence that antigen presenting cells (APCs) are not only key players in the initiation or prevention of an antigen-specific T lymphocyte-mediated adaptive immune response, but also critical regulators and integrators in the interplay between our innate and adaptive immune system. Structured in a clear way to allow access to a very broad readership, the book is written from the viewpoint of a biochemist, immunologist, and scientist with experience in drug development. It covers all cell types involved in antigen presentation, providing the latest immunological facts with a focus on drug development. Backed by a glossary explaining all important technical terms, this short but comprehensive reference covers basic introductory aspects right up to details for advanced specialists.
