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5 research outputs found
A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes
Author
Binbing Yu
Harry Yang
+9 more
ICH Q3A(R2)
ICH Q3B(R2)
ICH Q3C(R6)
ICH Q6A
ICH Q6B
Lingmin Zeng
Manola A.
Porter B.
Thomas A.
Publication venue
'Informa UK Limited'
Publication date
Field of study
No full text
Crossref
Simultaneous determination of elbasvir and grazoprevir in fixed-dose combination and mass spectral characterization of each degradation product by UHPLC-ESI-QTOF-MS/MS
Author
Alric
Alsante
+19 more
Alsante
Andreas Stämpfli
Goday
Gopal
ICH Q1B
ICH Q2(R1)
ICH Q3A(R2)
ICH Q3B(R2)
International Council for Harmonization Q1A (R2)
Junli Chen
Kleinman
Liqin Chen
Liu
Mingqiu Lu
Pillai
Potluri
Rahman
Tønnesen
Zepatier
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Forced Degradation Studies of Ivabradine and In Silico Toxicology Predictions for Its New Designated Impurities
Author
Alavijeh
Bergström
+27 more
Carstensen
Danielson
DiFrancesco
Dow
EMA
EMEA
ePhysChem
Francois-Bouchard
Gfeller
Glass
Huynh-Ba
ICH Q1A (R)
ICH Q1A (R2)
ICH Q3A
ICH Q3B (R)
Jamrógiewicz
Lu
Maggio
Modi
Olsen
Patel
Postea
Singh
Singh
Toxtree
Waterman
Zanger
Publication venue
'Frontiers Media SA'
Publication date
Field of study
No full text
Crossref
Application of Differential Pulse Polarography for Detection of Riboflavin from Pharmaceutical Samples and Vegetables
Author
Annapoorna S. R.
Brezina M.
+21 more
COMA
Dahmen E. A. M. F.
Eurachem
European commission
Ewing G. W.
Hart J. P.
Harvey D.
Heyrovsky J.
ICH Q2A
ICH Q2A
ICH Q2B
ICH Q2B
ICH Q3A (R2)
ICH Q6A
Indian Pharmaceutical Guide
Kashid L. M.
Meitis L.
Sethi P. D.
U.S. FDA
U.S. FDA
Utama G. L.
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: A comprehensive review
Author
Ahuja
Alegre
+100 more
Alzaga
An
Ashby
Ashby
Bai
Bercu
Bercu
Bolt
Borman
Bouder
Carere
Cimarosti
Committee for Proprietary Medicinal Products (CPMP)
Cunningham
David
Deepti
Dejaegher
Derek
Dobo
Elder
Elder
Elder
Elder
Elder
European Medicines Agency (EMA)
Fellows
Fetterman
Fiori
Flamand
Friscia
Frost
Frumkin
Glyenhaal
Gorog
Hao
Hmelnickis
Humfrey
ICH Q3A (R2)
ICH Q3B (R2)
ICH Q3C
ICH Q3D
Jacobson Kram
Kenyon
Kirtley
Kondo
Kovarikova
Kruhlak
Kushwaha
Leblanc
Lee
Lee
Li
Liu
Liu
Liu
Matsui
Matthews
Mueller
Ohnishi
Parks
Patterson
Pierson
Qixin
Raillard
Ramakrishna
Raman
Raman
Rao
Regalado
Snodin
Snyder
Snyder
Snyder
Snyder
Sobol
Soman
Srinivasa Rao
Sun
Sun
Sun
Teasdale
Teasdale
Vanhoenacker
Venugopal
Venugopal
Venugopal
Vijaya Bhaskar Reddy
Vijaya Bhaskar Reddy
Votano
Waegemaekers
Wang
Wang
Whysner
Yu
Yuabova
Zang
Zhang
Zhang
Zhou
Zhou
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref