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8 research outputs found
A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes
Author
Binbing Yu
Harry Yang
+9Â 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
Potency assignment of biotherapeutic reference standards
Author
Bhavin S. Parekh
Borer
+16Â more
Borer
Chow
Food and Drug Administration
Hauck
ICH Q6B
ICH Q7
Kristi L. Griffiths
Kupper
Matthew W. Borer
Metcalfe
Mire-Sluis
Paul Faya
Schiel
World Health Organization (WHO)
World Health Organization (WHO)
World Health Organization (WHO)
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Biosimilar Law and Regulation: An Essential Guide
Author
. . . Reporting
. . Legalbasis
+75Â more
. . Legalbasis
. . Mainguidelinetext
. . Post-Market Requirements
. . Reference Biologic Drug
. . References
. . Tableofcontents Executivesummary
. R Dr
? Guidelineonclinicalinvestigationofthepharmacokineticsoftherapeuticproteins
? Guidelineonriskmanagementsystemsformedicinalproductsforhumanuse
? Guidelineonsimilarbiologicalproducts
? Ichtopice10-Noteforguidanceonchoiceofcontrolgroupinclinicaltrials
? Noteforguidanceongoodclinicalsafetydatamanagement
A Dr
A Dr
A Mrs
Ahmed
Dr Kwasi Nyarko
E Dr
E G See
Ema See
Ema See
Emea/Chmp/Bwp
Emea/Chmp/Bwp
Erika Fisher / King Lietzan
Food Shacter
Guidelineonsimilarbiologicalmedicinalproductscontaining . . Biotechnology-Derivedproteinsasactivesubstance:Qualityissues Executivesummary
H Dr
H M J Dr
I Dr
Ich Q1a
Ich Q2b Guideline
Ich Q5a Guideline
Ich Q5b Guideline
Ich Q5c Guideline
Ich Q5d Guideline
Ich Q5e
Ich Q5e Guideline
Ich Q6b
Ich Q6b Guideline
Ich S6
Ich S6 Guideline
Id
J Dr
J Dr
J Dr
J Dr
J Dr
J Joung
J Woodcock
K Dr
M Dr
M Dr
M Ms
P D Dr
P Dr
P J Heim
Page2
Page4
Qualityaspects . Comparabilityexerciseversusreferenceproduct
R Dr
R Dr
Ramsey Baghdadi
References ? Guidelineonsimilarbiologicalmedicinalproductscontainingbiotechnology
S Dr
S Dr
S Dr
S Dr
S Dr
S Dr
S Ms
See Letter From Steven
Steven K Letter From
Switzerland
Y H Mrs
Yamaguchi Dr Teruhide
Publication venue
'Elsevier BV'
Publication date
01/01/2011
Field of study
No full text
Crossref
Impurity investigations by phases of drug and product development
Author
Alavattam Sreedhara
Alsante
+43Â more
Alsante
Alsante
Alsante
Baertschi
Bailey-Kellogg
Bernard A. Olsen
Boll
Boudreau
Carter-Franklin
Champion
Champion
Dow
EMA
Farrell
Foti
Harvey
ICH Q11 Guideline
ICH Q6B Specifications
Jansen
Jawa
Khawli
Kleinman
Kleinman
Knezevic
Krawitz
Levy
Liu
Madsen
Mehta
Nowak
Olsen
Olsen
Raillard
Reddy
Reynolds
Singh
Snodin
Steven W. Baertschi
Wang
Waterman
Yin
Zhang
Zhu-Shimoni
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Analytical comparability assessment on glycosylation of ziv-aflibercept and the biosimilar candidate
Author
Aich
Anthony
+39Â more
Ayoub
Beck
Beck
Beck
China National Medical Product Administration
Chung
Desaire
DiPaola
Dotz
Duivelshof
D’Atri
D’Atri
European Medicines Agency
Ferrara
Gahoual
Ghaderi
Higel
ICH. Q5E
ICH. Q6B
Japan Pharmaceutical and Medical Devices Agency
Jefferis
John
Kaneko
Largy
Lin
Liu
Liu
Papadopoulos
Rafael
Reusch
Sinclair
Strohl
United States Food and Drug Administration
Wada
Warne
Yu
Zhang
Zhang
Zhu
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Host cell protein adsorption characteristics during protein a chromatography
Author
Berrill
Caparon
+44Â more
Champion
Champion
Chhatre
Clark
Eaton
Fahrner
Flatman
Gao
Gemoll
Ghose
Gottschalk
Grzeskowiak
Hahn
Hahn
Humphreys
Hunter
ICH Q6B 1999
Jenkins
Jin
Kandula
Krawitz
Kumar
Liu
Lydersen
McDonald
Meleady
Nogal
Peram
Peters
Pezzini
Shukla
Shukla
Shukla
Shukla
Shukla
Sol
Tait
Wang
Wang
Westoby
Wierling
Yigzaw
Yumioka
Zhou
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
Successive multiple ionic polymer layer coated capillaries in the separation of proteins - Recombinant allergen variants as a case study
Author
Afif
Amon
+47Â more
Bollen
Bousquet
Catai
Catai
Catai
Chapman
Cromwell
Danger
Doherty
Dullnig
Engelhardt
Ermakov
Ferreira
Graul
Grégoire
Gurov
Hallberg
Hoffmann-Sommergruber
Houska
ICH Guideline Q6B
Jiang
Kamande
Kapnissi-Christodoulou
Katayama
Katayama
Kronsteiner
Kronsteiner
Kálmán
Lai
Liufu
Lucy
Nehmé
Nehmé
Nylander
Patrick
Pettersen
Punzet
Samoshina
Schlenoff
Schwer
Stutz
Stutz
Svensson
Tanaka
Tresch
Valenta
Wang
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
Regulatory perspective on in vitro potency assays for human T cells used in anti-tumor immunotherapy
Author
Adair
Ahmadzadeh
+127Â more
Allard
Allegrezza
Anurathapan
Bachy
Baldan
Barry
Basu
Betts
Bluestone
Bravery
Brunner
Bruno
Budde
Burkett
Butterfield
Cameron
Chahroudi
Charlotte de Wolf
Cheadle
Chen
Chávez-Galán
Clay
Cohen
Dawson
de Aquino
de Charette
Dudley
Dudley
Dwarshuis
Edinger
EMEA/CHMP/410869/2006
EMEA/CHMP/BWP/271475/2006
Feoktistova
Figueroa
Finke
Fraietta
Frey
Friedl
Friedman
Fu
Garrido
Gazagne
Geyer
Golubovskaya
Gros
Gupta
Guthrie
Halle
Haso
He
Hegmans
Hermans
Hinz
Hoves
Höppner
ICH Guideline Q2(R1)
ICH Guideline Q6B
Jagarlamoody
Janetzki
Jedema
Jerome
Jing
Johnson
Johnson
Johnson
Kalos
Kienzle
Kim
Kim
Kochenderfer
Kochenderfer
Kumai
KĂĽnkele
Lecoeur
Levine
Liadi
Lim
Linette
Liu
MacDonald
Mackensen
Malyguine
Marcel Hoefnagel
Marja van de Bovenkamp
Matsuzaki
Matzinger
Mitra
Moeller
Moeller
Morgan
Nagata
Nagata
Nakagawa
Peper
Pimpaneau
Quezada
Rapoport
Robbins
Russell
Scarfò
Schäfer
Seiter
Seledtsov
Sheehy
Snyder
Sommermeyer
Song
Stroncek
Stroncek
Suni
Tawara
Tsukahara
Turtle
U.S. Food and Drug Administration
Van Der Hoorn
Voskoboinik
Wang
Wang
Wang
Wegner
Whiteside
Xie
Xu
Yang
Yang
Zaritskaya
Zaritskaya
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref