These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
221 related articles for article (PubMed ID: 36168002)
1. Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines. Popkin ME; Goese M; Wilkinson D; Finnie S; Flanagan T; Campa C; Clinch A; Teasdale A; Lennard A; Cook G; Mohan G; Osborne MD AAPS J; 2022 Sep; 24(6):101. PubMed ID: 36168002 [TBL] [Abstract][Full Text] [Related]
2. Considerations for the chemistry, manufacturing and Controls (CMC) - quality package for COVID-19 vaccines- interim lessons learnt by the European medicines Agency (EMA). Shivji R; Conocchia R; Korakianiti E; Jekerle V Vaccine; 2022 Sep; 40(38):5539-5541. PubMed ID: 35779964 [TBL] [Abstract][Full Text] [Related]
3. Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future-An Industry View. Geraci G; Bernat J; Rodier C; Acha V; Acquah J; Beakes-Read G Ther Innov Regul Sci; 2023 Sep; 57(5):940-951. PubMed ID: 37266868 [TBL] [Abstract][Full Text] [Related]
4. How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation. McGoldrick M; Gastineau T; Wilkinson D; Campa C; Clercq N; Mallia-Milanes A; Germay O; Krishnan J; Van Ooij M; Thien MP; Mlynarczyk PJ; Saltus E; Juvin P; Clenet D; Basso A; Dellepiane N; Pagliusi S; de Moraes Stávale MC; Sivaramakrishnan VH; Desai S Vaccine; 2022 Feb; 40(9):1215-1222. PubMed ID: 35180993 [TBL] [Abstract][Full Text] [Related]
5. Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China. Lu J; Wei W; He W Biologicals; 2023 Nov; 84():101700. PubMed ID: 37708679 [TBL] [Abstract][Full Text] [Related]
6. Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine. Gastineau T; Ban C; Basso A; Brehme F; Silva AL; Faure O; Palaire LL; Persaud P; Rodriguez H PDA J Pharm Sci Technol; 2024 Aug; 78(4):388-398. PubMed ID: 37973190 [TBL] [Abstract][Full Text] [Related]
7. How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation. McGoldrick M; Gastineau T; Wilkinson D; Campa C; De Clercq N; Mallia-Milanes A; Germay O; Krishnan J; Van Ooij M; Thien MP; Mlynarczyk PJ; Saltus E; Wauters F; Juvin P; Clenet D; Basso A; Dellepiane N; Pagliusi S; Collaço de Moraes Stávale M; Sivaramakrishnan VH; Desai S Vaccine; 2022 Feb; 40(9):1223-1230. PubMed ID: 35180994 [TBL] [Abstract][Full Text] [Related]
8. Innovative medicine development. Pimpaneau V; Voisin E Technol Health Care; 2022; 30(2):499-503. PubMed ID: 34957973 [TBL] [Abstract][Full Text] [Related]
9. The future of Cochrane Neonatal. Soll RF; Ovelman C; McGuire W Early Hum Dev; 2020 Nov; 150():105191. PubMed ID: 33036834 [TBL] [Abstract][Full Text] [Related]
10. How manufacturing won or lost the COVID-19 vaccine race. King ML Vaccine; 2024 Feb; 42(5):1004-1012. PubMed ID: 38228438 [TBL] [Abstract][Full Text] [Related]
11. Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide : Joint Position from EFPIA, IFPMA and Vaccines Europe. Deavin A; Adam S; Ausborn S; Nielsen ASB; Cappellini S; Colmagne-Poulard I; Gastineau T; Gonzalez-Martinez A; Meillerais S; Mortazavi C Ther Innov Regul Sci; 2023 Jan; 57(1):7-11. PubMed ID: 35917091 [TBL] [Abstract][Full Text] [Related]
12. Vaccines for a healthy future: 21st DCVMN Annual General Meeting 2020 report. Pagliusi S; Hayman B; Jarrett S Vaccine; 2021 Apr; 39(18):2479-2488. PubMed ID: 33838948 [TBL] [Abstract][Full Text] [Related]
13. Clinical development and approval of COVID-19 vaccines. Kalinke U; Barouch DH; Rizzi R; Lagkadinou E; Türeci Ö; Pather S; Neels P Expert Rev Vaccines; 2022 May; 21(5):609-619. PubMed ID: 35157542 [TBL] [Abstract][Full Text] [Related]
14. Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance. Rahalkar H; Sheppard A; Salek S Expert Rev Clin Pharmacol; 2022 Feb; 15(2):215-236. PubMed ID: 35078378 [TBL] [Abstract][Full Text] [Related]
15. Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins. Broly H; Souquet J; Beck A MAbs; 2023; 15(1):2220150. PubMed ID: 37278452 [TBL] [Abstract][Full Text] [Related]
16. Considerations for rapid development and licencing of conventional and platform technology veterinary vaccines. Francis MJ Avian Pathol; 2022 Apr; 51(2):107-112. PubMed ID: 35201912 [TBL] [Abstract][Full Text] [Related]
17. Influenza virus vaccine live intranasal--MedImmune vaccines: CAIV-T, influenza vaccine live intranasal. Drugs R D; 2003; 4(5):312-9. PubMed ID: 12952502 [TBL] [Abstract][Full Text] [Related]
18. Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities. Mangia F; Lin YM; Armando J; Dominguez K; Rozhnova V; Ausborn S Ther Innov Regul Sci; 2024 Nov; 58(6):997-1005. PubMed ID: 39048766 [TBL] [Abstract][Full Text] [Related]
19. A Global Industry Survey on Post-Approval Change Management and Use of Reliance. Deavin A; Hossain A; Colmagne-Poulard I; Wong KC; Perea-Vélez M; Cappellini S; Ausborn S; Meillerais S; Bourguignon C Ther Innov Regul Sci; 2024 Nov; 58(6):1094-1107. PubMed ID: 39179719 [TBL] [Abstract][Full Text] [Related]
20. Innovative vaccine approaches-a Keystone Symposia report. Cable J; Rappuoli R; Klemm EJ; Kang G; Mutreja A; Wright GJ; Pizza M; Castro SA; Hoffmann JP; Alter G; Carfi A; Pollard AJ; Krammer F; Gupta RK; Wagner CE; Machado V; Modjarrad K; Corey L; B Gilbert P; Dougan G; Lurie N; Bjorkman PJ; Chiu C; Nemes E; Gordon SB; Steer AC; Rudel T; Blish CA; Sandberg JT; Brennan K; Klugman KP; Stuart LM; Madhi SA; Karp CL Ann N Y Acad Sci; 2022 May; 1511(1):59-86. PubMed ID: 35029310 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]