Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics PDF Download
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Author:
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ISBN:
Category : Drug packaging industry
Languages : en
Pages : 36
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Book Description
Author:
Publisher:
ISBN:
Category : Drug packaging industry
Languages : en
Pages : 36
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Author: Center for Drugs and Biologics
Publisher:
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Category :
Languages : en
Pages : 52
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Category : Biological products
Languages : en
Pages : 76
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Author:
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ISBN:
Category : Drug packaging industry
Languages : en
Pages : 44
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Author:
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ISBN:
Category : Drugs
Languages : en
Pages : 28
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Author:
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ISBN:
Category : Drugs
Languages : en
Pages : 20
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Author: Les Schnoll
Publisher: Paton Professional
ISBN: 9781932828191
Category : Law
Languages : en
Pages : 564
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Author:
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Category : Administrative law
Languages : en
Pages : 1068
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Author: Ved Srivastava
Publisher: Royal Society of Chemistry
ISBN: 1788014332
Category : Science
Languages : en
Pages : 572
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Book Description
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: Ali M. Emran
Publisher: Springer Science & Business Media
ISBN: 1475796706
Category : Medical
Languages : en
Pages : 528
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Book Description
To continue the support for the growing trend of chemistry involvement in nuclear medicine, the Division of Nuclear Chemistry and Technology (DNCT) of the American Chemical Society (ACS) planned for a symposium to cover this aspect. This was expressed in arequest to me, as a member of the Program Committee, to organize a symposium on topics related to nuclear and radiochemistry applications to nuclear medicine. Realizing the growing interest in imaging, specially with positron emitting radioisotopes, I invited several colleagues to study with me the idea of imaging centers and the involvement of chemists in their structure and function. The formulated Organizing Committee supported this idea which evolved in proposing an extended international symposium to be held in conjunction with the 206th ACS National meeting in Chicago, Illinois, U. S. A. on August 22-27, 1993. The following are the members of the Organizing Committee: Jorge R. Barrio, Ph. D. Thomas E. Boothe, Ph. D. J. Robert Dahl, Ph. D. Robert F. Dannals, Ph. D. Bruce R. Erdal, Ph. D. Mark M. Goodman, Ph. D. George W. Kabalka, Ph. D. James F. Lamb, Ph. D. Ronald G. Manning, Ph. D. Henry C. Padgett, Ph. D. Roy S. Tilbury, Ph. D. Steven W. Yates, Ph. D. and Ali M. Emran, Ph. D.
