8 research outputs found
A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes
- Author
- Publication venue
- 'Informa UK Limited'
- Publication date
- Field of study
Potency assignment of biotherapeutic reference standards
- Author
- Publication venue
- 'Elsevier BV'
- Publication date
- Field of study
Biosimilar Law and Regulation: An Essential Guide
- Author
- . . . Reporting
- . . Legalbasis
- . . 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
Impurity investigations by phases of drug and product development
- Author
- Alavattam Sreedhara
- Alsante
- 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
Analytical comparability assessment on glycosylation of ziv-aflibercept and the biosimilar candidate
- Author
- Aich
- Anthony
- 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
Host cell protein adsorption characteristics during protein a chromatography
- Author
- Publication venue
- 'Wiley'
- Publication date
- Field of study
Successive multiple ionic polymer layer coated capillaries in the separation of proteins - Recombinant allergen variants as a case study
- Author
- Afif
- Amon
- 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
Regulatory perspective on in vitro potency assays for human T cells used in anti-tumor immunotherapy
- Author
- Adair
- Ahmadzadeh
- 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