Author: United States. Food and Drug Administration. Bureau of BiologicsPublisher:
ISBN:
Category :
Languages : en
Pages : 48
Book Description
Regulations for the Manufacture of Biological Products
Author: United States. Food and Drug Administration. Bureau of BiologicsPublisher:
ISBN:
Category :
Languages : en
Pages : 48
Book Description
Regulations for the Manufacture of Biological Products
Author: United States. Public Health ServicePublisher:
ISBN:
Category :
Languages : en
Pages : 111
Book Description
Regulations for the Manufacture of Biological Products
Author: National Institutes of Health (U.S.)Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 124
Book Description
Regulation of Biological Products
Author: United StatesPublisher:
ISBN:
Category : Biological products
Languages : en
Pages : 40
Book Description
Regulation for the Manufacture of Biological Products
Author: Combination Products
Author: Smita GopalaswamyPublisher: CRC Press
ISBN: 1040068960
Category : Business & Economics
Languages : en
Pages : 168
Book Description
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Author: John GeigertPublisher: Springer Nature
ISBN: 3031319095
Category : Science
Languages : en
Pages : 597
Book Description
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Author: Carmen MedinaPublisher: CRC Press
ISBN: 0824740785
Category : Medical
Languages : en
Pages : 604
Book Description
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Medical Product Regulatory Affairs
Author: John J. TobinPublisher: John Wiley & Sons
ISBN: 3527644717
Category : Science
Languages : en
Pages : 304
Book Description
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Author: