Pharmaceutical Formulation Development Of Peptides And Proteins PDF Download
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| Author | : Lars Hovgaard |
| Publisher | : CRC Press |
| Total Pages | : 392 |
| Release | : 2012-11-14 |
| Genre | : Medical |
| ISBN | : 1439853894 |
Download Pharmaceutical Formulation Development of Peptides and Proteins Book in PDF, ePub and Kindle
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 therap
| Author | : Lars Hovgaard |
| Publisher | : CRC Press |
| Total Pages | : 238 |
| Release | : 1999-12-16 |
| Genre | : Medical |
| ISBN | : 9781135737702 |
Download Pharmaceutical Formulation Development of Peptides and Proteins Book in PDF, ePub and Kindle
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.
| Author | : Eugene J. McNally |
| Publisher | : CRC Press |
| Total Pages | : 372 |
| Release | : 2007-10-26 |
| Genre | : Medical |
| ISBN | : 0849379520 |
Download Protein Formulation and Delivery Book in PDF, ePub and Kindle
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
| Author | : Ajay K. Banga |
| Publisher | : CRC Press |
| Total Pages | : 375 |
| Release | : 2005-09-14 |
| Genre | : Medical |
| ISBN | : 1420039830 |
Download Therapeutic Peptides and Proteins Book in PDF, ePub and Kindle
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
| Author | : Rodney Pearlman |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 371 |
| Release | : 2013-06-29 |
| Genre | : Medical |
| ISBN | : 1489912363 |
Download Stability and Characterization of Protein and Peptide Drugs Book in PDF, ePub and Kindle
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.
| Author | : Ajay K. Banga |
| Publisher | : CRC Press |
| Total Pages | : 396 |
| Release | : 2015-04-23 |
| Genre | : Medical |
| ISBN | : 1466566078 |
Download Therapeutic Peptides and Proteins Book in PDF, ePub and Kindle
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 c
| Author | : Zahra Shahrokh |
| Publisher | : |
| Total Pages | : 248 |
| Release | : 1997 |
| Genre | : Dosage forms |
| ISBN | : |
Download Therapeutic Protein and Peptide Formulation and Delivery Book in PDF, ePub and Kindle
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.
| Author | : Ved Srivastava |
| Publisher | : Royal Society of Chemistry |
| Total Pages | : 572 |
| Release | : 2019-08-28 |
| Genre | : Science |
| ISBN | : 1788014332 |
Download Peptide Therapeutics Book in PDF, ePub and Kindle
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.
| Author | : Yogeshwar Bachhav |
| Publisher | : John Wiley & Sons |
| Total Pages | : 470 |
| Release | : 2019-12-04 |
| Genre | : Science |
| ISBN | : 3527343962 |
Download Innovative Dosage Forms Book in PDF, ePub and Kindle
Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
| Author | : Chris Van Der Walle |
| Publisher | : Academic Press |
| Total Pages | : 380 |
| Release | : 2011-05-12 |
| Genre | : Science |
| ISBN | : 9780123849366 |
Download Peptide and Protein Delivery Book in PDF, ePub and Kindle
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
