4 research outputs found
Regulatory Implications of Excipient Changes in Medicinal Products
- Author
- A Hussain
- A Shah
- AP Sam
- AS Hussain
- AW Hoelzer
- B Perez-Marcos
- C Mroz
- Commission Regulations EC No. 541/95542/ 95 as amended by Commission Regulation EC 1146/981069/98.
- Committee for Proprietary Medicinal Products.
- Council of Europe.
- Council of Europe. Public Health Committee Partial Agreement.
- EU Guideline: Excipients in the dossier for application for marketing authorization of a medicinal product 3AQ9A. In
- EU Guideline: Excipients in the labelpackage leaflet of medicinal products for human use 3BC7A. In
- G Bolhuis
- ICH Guideline
- ICH Guideline
- IF Uchegbu
- IPEC-Americas guideline: Significant change guide for bulk pharmaceutical excipients.
- J Heller
- J Lutz
- M Landin
- M Landin
- M Landin
- M Steinberg
- M Whiteman
- MD Parker
- MD Ticehurst
- MR Billany
- P Haan de
- P Martino Di
- PK Wotton
- PM Thwaites
- R Langer
- R O’Laughlin
- RC Rowe
- RL Dunn
- The European Agency for the Evaluation of Medicinal Products.
- TM Jones
- U.S. FoodDrug Administration.
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textREDOX CONTROL OF INTEGRIN-MEDIATED HEPATIC INFLAMMATION IN SYSTEMIC AUTOIMMUNITY
- Author
- Against Diabetic Complications
- Alveolar Hemorrhage
- Autoimmune Hepatitis
- Chaplin DD
- Conner SD
- Damage Induced
- Diseases
- Endothelial Cells
- Enhanced Tumorigenesis
- Failure
- Fibrosis
- Gardner H.
- Guadagno NA
- Heard KJ
- Hynes RO
- Hynes RO.
- Implications
- Inflammation
- Jones DE
- Macrophages
- Medicinal Application
- Metabolic Syndrome Rats
- Metabolism
- Modulating
- Nephritis
- Pase Rab
- Pathway
- Perl A
- Rab
- Rab
- Rab
- Regeneration
- Review
- Signaling Pathway
- Signals
- Tian Z
- Translation
- Tsokos GC
- Upon
- Zimmerman GA
- Publication venue
- 'Mary Ann Liebert Inc'
- Publication date
- Field of study
No full textEthical and Legal Issues in Cord Blood Stem Cells and Biobanking
- Author
- Aditya
- Agamben
- Altavilla
- Amy
- Beauchamp
- Bellivier
- Blumberg-Mokri
- Broxmeyer
- Cluckman
- Comité Consultatif National d’ Éthique
- Committee on Establishing a National Cord Blood Stem Cell Bank Program
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
- Engelhardt
- Forraz
- Fung
- Gabolde
- Gailloux
- Guindi
- Havstad
- Hennette-Vauchez
- Jonas
- Kahn
- Kurosu
- Lysaght
- Marville
- Mason
- Mauss
- Medicinal Products Act
- Murdoch
- Nerson
- NetCord-FACT
- Norman
- Notta
- Nuffield Council on Bioethics
- Ong
- Petrini
- Petrini
- Rial-Sebbag
- Ricœur
- Saura
- Singler
- Steinsbekk
- Technopolis group
- Teskrat
- Turhan
- UK Biobank
- Yamanaka
- Yu
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2015
- Field of study
No full textEnhancing vaccine safety capacity globally: A lifecycle perspective
- Author
- Ali
- Alonso
- Andre
- Baggs
- Baker
- Balinska
- Ball
- Ball
- Barker
- Baxter
- Baylor
- Belgharbi
- Black
- Black
- Black
- Bonhoeffer
- Bonhoeffer
- Botsis
- Bratton
- Chen
- Chen
- Chen
- Chen
- Committee for Medicinal Product for Human Use (CHMP)
- Czerkinsky
- Daniel M. Weibel
- David B. Martin
- Destefano
- Dieleman
- Diomande
- Dodd
- Dourado
- Dube
- DuMouchel
- Elam-Evans
- Ellenberg
- Elmgren
- European Centre for Disease Prevention and Control (ECDC)
- Faich
- Farrington
- Faucette
- Fenner
- Fine
- Francois
- Freitas
- Gangarosa
- Gee
- Glanz
- Gowda
- Greene
- Grohskopf
- Gust
- HCUP
- Hickler
- Hinrichsen
- Hutin
- Hviid
- Institute of Medicine (IOM)
- Institute of Medicine (IOM)
- Izurieta
- Jegede
- Kaddar
- Kaslow
- Keller-Stanislawski
- Kennedy
- Kharbanda
- Klein
- Kramarz
- Kulldorff
- Kulldorff
- Lane
- LaRussa
- Lee
- Lieu
- Lieu
- Lilienfeld
- Maglione
- Mahoney
- Martin
- Maure
- McClure
- McNeil
- Miriam Sturkenboom
- Mitchell
- Monath
- Moxon
- Nabel
- Nathanson
- Nathanson
- Nguyen
- Niu
- Nunnally
- Oberg
- Offit
- Ouandaogo
- Pagliusi
- Pasternak
- Patel
- Patrick L.F. Zuber
- Pool
- Prausnitz
- Prevots
- Rappuoli
- Rasmussen
- Robert T. Chen
- Romio
- Salmon
- Saroja
- Savel
- Schijns
- Schonberger
- Seeff
- Shimabukuro
- Smith
- Smith
- Stetler
- Stockwell
- Swamy
- Szarfman
- Taylor
- The Lancet
- Tom T. Shimabukuro
- Trifiro
- Tse
- U.S. Centers for Disease Control and Prevention (CDC). [Docket No. CDC-2014-0015]
- U.S. Centers for Disease Control Prevention (CDC)
- U.S. Food and Drug Administration (FDA)
- U.S. Food and Drug Administration (FDA)
- U.S. Food and Drug Administration (FDA)
- U.S. Food and Drug Administration (FDA)
- U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research
- U.S. Food and Drug Administration (FDA). 21 CFR Part 4 [Docket No. FDA-2009-N-0435]
- U.S. Food and Drug Administration (FDA). 21 CFR Parts 310 314, 329, and 600. [Docket No. FDA-2008-N-0334]. RIN 9010-AF96
- U.S. Food and Drug Administration (FDA). [Docket No. FDA-2001-D-0067 (Formerly Docket No. 2001D-0185)]
- U.S. National Institutes of Health (NIH)
- Vaccine Adverse Event Reporting System (VAERS) Application for Mobile Devices
- Wakefield
- Wang
- Wanjek
- White
- WHO
- Wijnans
- Wilson
- World Health Organization (WHO)
- World Health Organization (WHO)
- World Health Organization (WHO)
- World Health Organization (WHO)
- World Health Organization (WHO)
- World Health Organization (WHO)
- Yih
- Zhou
- Zipprich
- Publication venue
- 'Elsevier BV'
- Publication date
- Field of study
No full text
