Development Of Biopharmaceutical Parenteral Dosage Forms

Download Development Of Biopharmaceutical Parenteral Dosage Forms full books in PDF, epub, and Kindle. Read online Development Of Biopharmaceutical Parenteral Dosage Forms ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Development of Biopharmaceutical Parenteral Dosage Forms

Author : Cosimo Prantera
Publisher : CRC Press
ISBN 13 : 0585378002
Total Pages : 265 pages
Book Rating : 4.5/5 (853 download)

DOWNLOAD NOW!

Book Synopsis Development of Biopharmaceutical Parenteral Dosage Forms by : Cosimo Prantera

Download or read book Development of Biopharmaceutical Parenteral Dosage Forms written by Cosimo Prantera and published by CRC Press. This book was released on 1997-07-25 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Formsdetails biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable.

Pharmaceutical Dosage Forms - Parenteral Medications

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 1420086480
Total Pages : 328 pages
Book Rating : 4.4/5 (2 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Dosage Forms - Parenteral Medications by : Sandeep Nema

Download or read book Pharmaceutical Dosage Forms - Parenteral Medications written by Sandeep Nema and published by CRC Press. This book was released on 2016-04-19 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the

Pharmaceutical Dosage Forms - Parenteral Medications

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 1420086464
Total Pages : 420 pages
Book Rating : 4.4/5 (2 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Dosage Forms - Parenteral Medications by : Sandeep Nema

Download or read book Pharmaceutical Dosage Forms - Parenteral Medications written by Sandeep Nema and published by CRC Press. This book was released on 2016-04-19 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the

Parenteral Medications, Fourth Edition

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 042957472X
Total Pages : 2756 pages
Book Rating : 4.4/5 (295 download)

DOWNLOAD NOW!

Book Synopsis Parenteral Medications, Fourth Edition by : Sandeep Nema

Download or read book Parenteral Medications, Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 2756 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Pharmaceutical Dosage Forms - Parenteral Medications

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 1420086448
Total Pages : 424 pages
Book Rating : 4.4/5 (2 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Dosage Forms - Parenteral Medications by : Sandeep Nema

Download or read book Pharmaceutical Dosage Forms - Parenteral Medications written by Sandeep Nema and published by CRC Press. This book was released on 2016-04-19 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the

Pharmaceutical Preformulation and Formulation

Author : Mark Gibson
Publisher : CRC Press
ISBN 13 : 1420073184
Total Pages : 562 pages
Book Rating : 4.4/5 (2 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Preformulation and Formulation by : Mark Gibson

Download or read book Pharmaceutical Preformulation and Formulation written by Mark Gibson and published by CRC Press. This book was released on 2016-04-19 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 ne

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author : Feroz Jameel
Publisher : John Wiley & Sons
ISBN 13 : 0470595876
Total Pages : 986 pages
Book Rating : 4.4/5 (75 download)

DOWNLOAD NOW!

Book Synopsis Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by : Feroz Jameel

Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel and published by John Wiley & Sons. This book was released on 2010-07-13 with total page 986 pages. Available in PDF, EPUB and Kindle. Book excerpt: A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Dosage Forms, Formulation Developments and Regulations

Author : Amit Kumar Nayak
Publisher : Elsevier
ISBN 13 : 0323972462
Total Pages : 759 pages
Book Rating : 4.3/5 (239 download)

DOWNLOAD NOW!

Book Synopsis Dosage Forms, Formulation Developments and Regulations by : Amit Kumar Nayak

Download or read book Dosage Forms, Formulation Developments and Regulations written by Amit Kumar Nayak and published by Elsevier. This book was released on 2023-12-09 with total page 759 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. Examines trends and recent technologies in dosage, formulation and regulation Contains contributions from leading experts in academia, research, industry and regulatory agencies Includes high-quality illustrations, flow charts and tables for easy understanding of concepts Discusses practical examples and research case studies

Biopharmaceutics Applications in Drug Development

Author : Rajesh Krishna
Publisher : Springer Science & Business Media
ISBN 13 : 038772379X
Total Pages : 416 pages
Book Rating : 4.3/5 (877 download)

DOWNLOAD NOW!

Book Synopsis Biopharmaceutics Applications in Drug Development by : Rajesh Krishna

Download or read book Biopharmaceutics Applications in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2007-09-20 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Author : Ashok Katdare
Publisher : CRC Press
ISBN 13 : 1420004131
Total Pages : 474 pages
Book Rating : 4.4/5 (2 download)

DOWNLOAD NOW!

Book Synopsis Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems by : Ashok Katdare

Download or read book Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems written by Ashok Katdare and published by CRC Press. This book was released on 2006-07-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

Pharmaceutical Dosage Forms and Drug Delivery

Author : Ram I. Mahato
Publisher :
ISBN 13 : 9781032480602
Total Pages : 0 pages
Book Rating : 4.4/5 (86 download)

DOWNLOAD NOW!

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

Download or read book Pharmaceutical Dosage Forms and Drug Delivery written by Ram I. Mahato and published by . This book was released on 2024-11-13 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, this fourth edition elucidates the principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery - including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever. Consequently, this edition of the book emphasizes the heightened focus that the recent remarkable progress in gene editing, immunotherapy, and nanotechnology has brought to the design of new drugs and diagnostic approaches along with novel dosage forms. Apart from new chapters, this edition highlights the emerging emphasis on the role of artificial intelligence (AI) in drug discovery, mRNA and antibody-based therapies, genome editing, immunotherapy, chemical kinetics, and the stability of drug products. Features: - Includes new chapters on antibody therapeutics, gene editing, and immunotherapy. - Explains newer approaches and future methods and the significance of artificial intelligence (AI) in drug discovery. - Updated sections on pharmacy mathematics, chemical kinetics, and the stability of medicinal products. - Important updates on parenteral drug products, protein and peptide treatments, and biotechnology-based pharmaceuticals to provide a contemporary perspective on drug development, delivery, and pharmaceutical sciences. - Expansion of review questions and answers to clarify concepts for students and add to their grasp of key concepts covered in this book. Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors, and professionals, saving their time and money. -

Pharmaceutical Dosage Forms and Drug Delivery

Author : Ram I. Mahato
Publisher : CRC Press
ISBN 13 : 1420009206
Total Pages : 334 pages
Book Rating : 4.4/5 (2 download)

DOWNLOAD NOW!

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

Download or read book Pharmaceutical Dosage Forms and Drug Delivery written by Ram I. Mahato and published by CRC Press. This book was released on 2007-06-07 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Integrating aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, Pharmaceutical Dosage Forms and Drug Delivery elucidates basic physicochemical principles and their application in the design of dosage forms. The author addresses the relevance of these principles to the biopharmaceutical aspects of drugs. He explores the latest developments in the application of biomaterials, including polymers and biotechnology-based agents, to the development of novel dosage forms. The book covers physicochemical principles of dosage design, biopharmaceutical and physiological considerations, types of commonly used pharmaceutical dosage forms, introduction to polymeric biomaterials, protein and nucleic acid-based dosage forms, and novel and targeted drug delivery systems. It highlights the physicochemical parameters used for the design, development, and evaluation of biotechnological dosage forms and describes the biological barriers to drug absorption. Containing the right blend of mathematics, equations, diagrams, pictorials, and other pertinent information, this book provides a unified perspective that creates a greater overall understanding of basic science and cutting-edge technology.

Development and Manufacture of Protein Pharmaceuticals

Author : Steve L. Nail
Publisher : Springer Science & Business Media
ISBN 13 : 1461505496
Total Pages : 479 pages
Book Rating : 4.4/5 (615 download)

DOWNLOAD NOW!

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 Science & Business Media. This book was released on 2012-12-06 with total page 479 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.

Sterile Drug Products

Author : Michael J. Akers
Publisher : CRC Press
ISBN 13 : 9780849339936
Total Pages : 0 pages
Book Rating : 4.3/5 (399 download)

DOWNLOAD NOW!

Book Synopsis Sterile Drug Products by : Michael J. Akers

Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2010-08-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Dosage Form Design Considerations

Author :
Publisher : Academic Press
ISBN 13 : 0128144246
Total Pages : 881 pages
Book Rating : 4.1/5 (281 download)

DOWNLOAD NOW!

Book Synopsis Dosage Form Design Considerations by :

Download or read book Dosage Form Design Considerations written by and published by Academic Press. This book was released on 2018-07-28 with total page 881 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Integrated Pharmaceutics

Author : Antoine Al-Achi
Publisher : John Wiley & Sons
ISBN 13 : 0470596929
Total Pages : 1024 pages
Book Rating : 4.4/5 (75 download)

DOWNLOAD NOW!

Book Synopsis Integrated Pharmaceutics by : Antoine Al-Achi

Download or read book Integrated Pharmaceutics written by Antoine Al-Achi and published by John Wiley & Sons. This book was released on 2013-02-11 with total page 1024 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.

Pharmaceutical Dosage Forms

Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (21 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Dosage Forms by :

Download or read book Pharmaceutical Dosage Forms written by and published by . This book was released on 2010 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs. - An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. - A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures. - A definitive chapter on container-closure integrity. - New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins"--Résumé de l'éditeur.