Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

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Publisher : CRC Press
ISBN 13 : 1439853886
Total Pages : 395 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition by : Lars Hovgaard

Download or read book Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition written by Lars Hovgaard and published by CRC Press. This book was released on 2012-11-14 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Protein Formulation and Delivery

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Publisher : CRC Press
ISBN 13 : 0849379520
Total Pages : 372 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Protein Formulation and Delivery by : Eugene J. McNally

Download or read book Protein Formulation and Delivery written by Eugene J. McNally and published by CRC Press. This book was released on 2007-10-26 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytica

Pharmaceutical Formulation Development of Peptides and Proteins

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Publisher :
ISBN 13 : 9780203792421
Total Pages : 238 pages
Book Rating : 4.7/5 (924 download)

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Book Synopsis Pharmaceutical Formulation Development of Peptides and Proteins by :

Download or read book Pharmaceutical Formulation Development of Peptides and Proteins written by and published by . This book was released on 2000 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Therapeutic Peptides and Proteins

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Publisher : CRC Press
ISBN 13 : 1420039830
Total Pages : 375 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Therapeutic Peptides and Proteins by : Ajay K. Banga

Download or read book Therapeutic Peptides and Proteins written by Ajay K. Banga and published by CRC Press. This book was released on 2005-09-14 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up

Pharmaceutical Formulation Development of Peptides and Proteins

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Author :
Publisher : CRC Press
ISBN 13 : 9781135737702
Total Pages : 238 pages
Book Rating : 4.7/5 (377 download)

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Book Synopsis Pharmaceutical Formulation Development of Peptides and Proteins by : Lars Hovgaard

Download or read book Pharmaceutical Formulation Development of Peptides and Proteins written by Lars Hovgaard and published by CRC Press. This book was released on 1999-12-16 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical formulation of peptides and proteins has become an important part of modern drug development. Many new drugs are based on peptide or protein recombinant technology going hand in hand with more traditional pharmaceutical formulation. In order to develop products with optimal characters, it is important to give scientists interdisciplinary knowledge and a thorough understanding of the complex nature of pharmaceutical formulation of peptides and proteins. This comprehensive volume brings the different aspects of peptide and protein formulation into focus, beginning with the fundamentals of the production of peptides and proteins, ranging from peptide synthesis and recombinant DNA technology to protein purification. It discusses the characterization and chemical stability of peptides and proteins, before moving on to formulation, detailing peptides and proteins in solution and as suspensions, as well as lyophilized peptide and protein products. There follows a case study on drug delivery systems for alternative routes of administration. Finally, regulatory aspects are discussed in terms of chemical and pharmaceutical documentation. Each chapter is written by experts in their respective areas. Scientists in the industry and academia, and postgraduate students in pharmaceutical science will find this a valuable resource, which can be dipped in to as a reference, or studied as a whole.

Therapeutic Protein and Peptide Formulation and Delivery

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Publisher :
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Therapeutic Protein and Peptide Formulation and Delivery by : Zahra Shahrokh

Download or read book Therapeutic Protein and Peptide Formulation and Delivery written by Zahra Shahrokh and published by . This book was released on 1997 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume reviews protein stability and the analytical and biophysical characterization of proteins. It emphasizes drug delivery approaches, especially local delivery through the skin. Including both academic and industrial perspectives from such companies as Genentech, Amgen, and Merck, the book also discusses novel drug delivery polymers and the development of pharmaceutical protein formulations.

Therapeutic Peptides and Proteins

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Publisher : CRC Press
ISBN 13 : 1466566078
Total Pages : 400 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Therapeutic Peptides and Proteins by : Ajay K. Banga

Download or read book Therapeutic Peptides and Proteins written by Ajay K. Banga and published by CRC Press. This book was released on 2015-04-23 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis. The clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable, and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, microbiology, and chemical engineering and needs to keep abreast with the latest research in the published literature. Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Third Edition provides a comprehensive overview of the field for scientists in industry and academia and for students, while also providing practical information on the challenges facing the formulation and delivery aspects of these unique macromolecules. In particular, the book: Explains how recombinant DNA techniques now allow us to produce therapeutic proteins in a commercially viable form Discusses the physical and chemical pathways of peptide and protein degradation Includes a detailed discussion of protein formulation and lyophilization Overviews the pharmacokinetic aspects of therapeutic peptides and proteins and discusses controlled delivery systems for parenteral administration, including microsphere formulations Discusses research progress on oral, transdermal, mucosal, and topical delivery systems discusses transdermal and topical delivery

Stability and Characterization of Protein and Peptide Drugs

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Publisher : Springer Science & Business Media
ISBN 13 : 1489912363
Total Pages : 371 pages
Book Rating : 4.4/5 (899 download)

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Book Synopsis Stability and Characterization of Protein and Peptide Drugs by : Rodney Pearlman

Download or read book Stability and Characterization of Protein and Peptide Drugs written by Rodney Pearlman and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing. The editors have selected a wide range of molecules derived from monoclonal antibodies, recombinant DNA, and natural and chemical sources to provide formulation scientists with practical examples of the development of pharmaceutical products.

Peptide and Protein Delivery

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Publisher : Academic Press
ISBN 13 : 9780123849366
Total Pages : 380 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Peptide and Protein Delivery by : Chris Van Der Walle

Download or read book Peptide and Protein Delivery written by Chris Van Der Walle and published by Academic Press. This book was released on 2011-05-12 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growing area of peptide and protein therapeutics research is of paramount importance to medical application and advancement. A needed reference for entry level researchers and researchers working in interdisciplinary / collaborative projects, Peptide and Protein Delivery addresses the current and emerging routes for delivery of therapeutics. Covering cerebral delivery, pulmonary delivery, transdermal delivery, intestinal delivery, ocular delivery, parenteral delivery, and nasal delivery, this resource offers an overview of the main routes in therapeutics. Researchers across biochemistry, pharmaceutical, molecular biology, cell biology, immunology, chemistry and biotechnology fields will find this publication invaluable for peptide and protein laboratory research. Discusses the most recent data, ideas and concepts Presents case studies and an industrial perspective Details information from the molecular level to bioprocessing Thought provoking, for the novice to the specialist Timely, for today's biopharmaceuticals market

Development and Manufacture of Protein Pharmaceuticals

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Publisher : Springer
ISBN 13 : 9780306467455
Total Pages : 464 pages
Book Rating : 4.4/5 (674 download)

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Book Synopsis Development and Manufacture of Protein Pharmaceuticals by : Steve L. Nail

Download or read book Development and Manufacture of Protein Pharmaceuticals written by Steve L. Nail and published by Springer. This book was released on 2002-06-30 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.

Therapeutic Peptides and Proteins

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Publisher :
ISBN 13 : 9780367268176
Total Pages : 0 pages
Book Rating : 4.2/5 (681 download)

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Book Synopsis Therapeutic Peptides and Proteins by : Ajay K. Banga

Download or read book Therapeutic Peptides and Proteins written by Ajay K. Banga and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Peptide Therapeutics

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Publisher : Royal Society of Chemistry
ISBN 13 : 1788014332
Total Pages : 572 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Peptide Therapeutics by : Ved Srivastava

Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-28 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.

Drug Delivery Systems

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Publisher : Springer Science & Business Media
ISBN 13 : 1588298914
Total Pages : 255 pages
Book Rating : 4.5/5 (882 download)

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Book Synopsis Drug Delivery Systems by : Kewal K. Jain

Download or read book Drug Delivery Systems written by Kewal K. Jain and published by Springer Science & Business Media. This book was released on 2008-03-07 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this concise and systematic book, a team of experts select the most important, cutting-edge technologies used in drug delivery systems. They take into account significant drugs, new technologies such as nanoparticles, and therapeutic applications. The chapters present step-by-step laboratory protocols following the highly successful Methods in Molecular BiologyTM series format, offering readily reproducible results vital for pharmaceutical physicians and scientists.

Implantable Technologies

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Publisher : Royal Society of Chemistry
ISBN 13 : 1839165367
Total Pages : 323 pages
Book Rating : 4.8/5 (391 download)

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Book Synopsis Implantable Technologies by : Ved Srivastava

Download or read book Implantable Technologies written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2021-10-20 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implantable technologies allow for a sustained control over the release of pharmaceuticals into the bloodstream thereby achieving a controlled concentration with the potential to minimise side-effects while increasing patient compliance. Significant progress has been made in various alternative implantable delivery technologies, notably in intraocular and subcutaneous devices. Despite success in research and clinical studies, long-term clinical efficacy may be more limited and different aspects related to drug development and commercialization using these technologies are not well understood or practiced in the commercial setting. This book provides a comprehensive and cohesive picture of the latest in the field while also outlining the opportunities and challenges in implantable technology. Implantable Technologies: Pepties and Biologic Drug Development is an ideal reference for any postgraduate or researcher interested in utilising implantable technologies and novel routes of drug administration. The book will also be of interest to those involved in formulation and clinical application for a wide array of disease areas in addition to more established paradigms such as diabetes and pain management.

Pharmaceutical Dosage Forms and Drug Delivery, Second Edition

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Publisher : CRC Press
ISBN 13 : 1439849188
Total Pages : 514 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Pharmaceutical Dosage Forms and Drug Delivery, Second Edition by : Ram I. Mahato

Download or read book Pharmaceutical Dosage Forms and Drug Delivery, Second Edition written by Ram I. Mahato and published by CRC Press. This book was released on 2011-10-25 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the second edition of Pharmaceutical Dosage Forms and Drug Delivery the authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, emphasizing the increased attention that the recent spectacular advances in dosage form design and drug delivery, gene therapy, and nanotechnology have brought to the field. Highlights of the Second Edition: Additional author Ajit S. Narang brings an industrial practitioner perspective with increased focus on pharmacy math and statistics, and powders and granules Reorganized into three parts: Introduction, Physicochemical Principles, and Dosage Forms Chapters on pharmaceutical calculations, compounding principles, and powders and granules provide a complete spectrum of application of pharmaceutical principles Expansion of review questions and answers clarifies concepts for students and adds to their grasp of key concepts covered in the chapter Coverage of complexation and protein binding aspects of physical pharmacy includes the basic concepts as well as recent progress in the field Although there are numerous books on the science of pharmaceutics and dosage form design, most cover different areas of the discipline and do not provide an integrated approach to the topics. This book not only provides a singular perspective of the overall field, but it supplies a unified source of information for students, instructors, and professionals.

Peptide Applications in Biomedicine, Biotechnology and Bioengineering

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Publisher : Woodhead Publishing
ISBN 13 : 0081007426
Total Pages : 656 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Peptide Applications in Biomedicine, Biotechnology and Bioengineering by : Sotirios Koutsopoulos

Download or read book Peptide Applications in Biomedicine, Biotechnology and Bioengineering written by Sotirios Koutsopoulos and published by Woodhead Publishing. This book was released on 2017-11-16 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide Applications in Biomedicine, Biotechnology and Bioengineering summarizes the current knowledge on peptide applications in biomedicine, biotechnology and bioengineering. After a general introduction to peptides, the book addresses the many applications of peptides in biomedicine and medical technology. Next, the text focuses on peptide applications in biotechnology and bioengineering and reviews of peptide applications in nanotechnology. This book is a valuable resource for biomaterial scientists, polymer scientists, bioengineers, mechanical engineers, synthetic chemists, medical doctors and biologists. Presents a self-contained work for the field of biomedical peptides Summarizes the current knowledge on peptides in biomedicine, biotechnology and bioengineering Covers current and potential applications of biomedical peptides

Handbook of Bioequivalence Testing, Second Edition

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Publisher : CRC Press
ISBN 13 : 1482226375
Total Pages : 1012 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Handbook of Bioequivalence Testing, Second Edition by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing, Second Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.