|
|
|
|
| LEADER |
00000cam a2200000 i 4500 |
| 001 |
in00006521522 |
| 003 |
OCoLC |
| 005 |
20220616151046.0 |
| 008 |
210507t20212021dcu 000 0 eng d |
| 020 |
|
|
|a 9780309088671
|q (paperback)
|
| 020 |
|
|
|a 0309088674
|q (paperback)
|
| 020 |
|
|
|z 9780309104807
|q (electronic bk.)
|
| 035 |
|
|
|a (OCoLC)1250021153
|
| 040 |
|
|
|a NRC
|b eng
|e rda
|c NRC
|d NRC
|d OCLCO
|d TKN
|d IXA
|d OCLCO
|d OCLCF
|d EEM
|d UtOrBLW
|
| 043 |
|
|
|a n-us---
|
| 049 |
|
|
|a EEMR
|
| 050 |
|
4 |
|a HD9666.5
|b .I56 2021
|
| 245 |
0 |
0 |
|a Innovations in pharmaceutical manufacturing on the horizon :
|b technical challenges, regulatory issues, and recommendations /
|c Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing ; Board on Chemical Sciences and Technology ; Division on Earth and Life Studies.
|
| 264 |
|
1 |
|a Washington, DC :
|b The National Academies Press,
|c [2021]
|
| 264 |
|
4 |
|c ©2021
|
| 300 |
|
|
|a x, 110 pages ;
|c 28 cm.
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a unmediated
|b n
|2 rdamedia
|
| 338 |
|
|
|a volume
|b nc
|2 rdacarrier
|
| 490 |
1 |
|
|a Consensus study report of the National Academies of Sciences, Engineering, Medicine
|
| 504 |
|
|
|a Includes bibliographical references
|
| 505 |
0 |
|
|a Front Matter -- Summary -- 1. Introduction -- 2. Innovations in manufacturing drug substances -- 3 Innovations in manufacturing drug products -- 4. New control approaches to enable quality assurance and process capability -- 5. Innovations in integrated, flexible, and distributed manufacturing networks -- 6. Advancing innovation: observations, challenges, opportunities, and recommendations -- Appendix A: Biographic information on the Committee to Identify Innovative Technologies to Advances Pharmaceutical Manufacturing -- Appendix B: Disclosure of unavoidable conflicts of interest -- Appendix C: Workshop and webinar agenda -- Appendix D: Innovations in pharmaceutical manufacturing proceeding of a workshop - in brief -- Appendix E: Barriers to innovations in pharmaceutical manufacturing proceedings of a workshop - in brief
|
| 520 |
|
|
|a "In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further. At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years." --
|c Provided by publisher
|
| 650 |
|
0 |
|a Pharmaceutical industry
|x Capital productivity
|z United States.
|0 http://id.loc.gov/authorities/subjects/sh2010010879
|
| 650 |
|
0 |
|a Pharmaceutical industry
|x Production control
|z United States.
|
| 650 |
|
0 |
|a Pharmaceutical industry
|x Production standards
|z United States.
|
| 650 |
|
0 |
|a Pharmaceutical technology
|z United States.
|
| 650 |
|
7 |
|a Pharmaceutical industry
|x Capital productivity.
|2 fast
|0 (OCoLC)fst01767658
|
| 650 |
|
7 |
|a Pharmaceutical industry
|x Production control.
|2 fast
|0 (OCoLC)fst01060167
|
| 650 |
|
7 |
|a Pharmaceutical technology.
|2 fast
|0 (OCoLC)fst01060211
|
| 651 |
|
7 |
|a United States.
|2 fast
|0 (OCoLC)fst01204155
|
| 710 |
2 |
|
|a National Academies Press (U.S.),
|e publisher.
|0 http://id.loc.gov/authorities/names/no2003001840
|
| 710 |
2 |
|
|a National Academies of Sciences, Engineering, and Medicine (U.S.).
|b Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing,
|e issuing body.
|0 http://id.loc.gov/authorities/names/n2021184187
|
| 710 |
2 |
|
|a National Academies of Sciences, Engineering, and Medicine (U.S.).
|b Board on Chemical Sciences and Technology,
|e issuing body.
|0 http://id.loc.gov/authorities/names/n2016189280
|
| 710 |
2 |
|
|a National Academies of Sciences, Engineering, and Medicine (U.S.).
|b Division on Earth and Life Studies,
|e issuing body.
|0 http://id.loc.gov/authorities/names/n2016187773
|
| 776 |
0 |
8 |
|i Online version:
|a National Academies of Sciences, Engineering, and Medicine.
|t Innovations in Pharmaceutical Manufacturing on the Horizon.
|d Washington, D.C. : National Academies Press, 2021
|z 9780309104807
|w (OCoLC)1247659897
|
| 830 |
|
0 |
|a Consensus study report.
|0 http://id.loc.gov/authorities/names/n2017188206
|
| 907 |
|
|
|y .b144032624
|b 211104
|c 211028
|
| 998 |
|
|
|a mn
|b 211028
|c m
|d a
|e -
|f eng
|g dcu
|h 0
|i 2
|
| 994 |
|
|
|a C0
|b EEM
|
| 999 |
f |
f |
|i 86cf3d2f-c771-5611-afb5-446f0e3da269
|s 62d37df3-ede9-5873-b754-2bf7da04cf1c
|t 0
|
| 952 |
f |
f |
|p Can Circulate
|a Michigan State University-Library of Michigan
|b Michigan State University
|c MSU Main Library
|d MSU Main Library
|t 0
|e HD9666.5 .I56 2021
|h Library of Congress classification
|i Printed Material
|m 31293036314569
|n 1
|
