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Author: United States. Federal Highway Administration. Safety-Related Information Needs Task Force
Publisher:
ISBN:
Category :
Languages : en
Pages : 316
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Book Description
Author: United States. Federal Highway Administration. Safety-Related Information Needs Task Force
Publisher:
ISBN:
Category :
Languages : en
Pages : 316
Get Book Here
Book Description
Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 778
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Author: John Geigert
Publisher: Springer Science & Business Media
ISBN: 144199131X
Category : Medical
Languages : en
Pages : 365
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Book Description
"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
Author: United States. National Highway Traffic Safety Administration
Publisher:
ISBN:
Category : Traffic safety
Languages : en
Pages : 548
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Author:
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Category : Automobiles
Languages : en
Pages : 168
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Book Description
Author:
Publisher:
ISBN:
Category : Traffic safety
Languages : en
Pages : 172
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Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 172
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Author:
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Category : Delegated legislation
Languages : en
Pages : 1952
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Author: IAEA
Publisher: International Atomic Energy Agency
ISBN: 9201012217
Category : Medical
Languages : en
Pages : 166
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Book Description
This Safety Report provides guidance on the safe use of radiation for imaging and treatment in veterinary medicine with the objective of ensuring the safety and radiation protection of workers and members of the public. The publication addresses occupational exposure and public exposure in the use of radiation in veterinary medicine and safety issues that should be considered in order to be compliant with the International Basic Safety Standards (IAEA Safety Standards Series No. GSR Part 3). Consideration is given to the topics of source security and emergency response that might arise with the use of radioactive material in veterinary medicine. Although primarily intended for regulators and workers in veterinary medicine, the publication will also be relevant for professional bodies, ethics committees, and suppliers of equipment and software.
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Category : Evaluation research (Social action programs)
Languages : en
Pages : 1032
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Book Description
Contains an inventory of evaluation reports produced by and for selected Federal agencies, including GAO evaluation reports that relate to the programs of those agencies.
