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11 research outputs found
Advances in Instrumental Technology, Industry Guidance and Data Management Systems Enabling the Widespread Use of near Infrared Spectroscopy in the Pharmaceutical/Biopharmaceutical Sector
Author
Broad N.
Ciurczak E.W.
+12Â more
ICH Harmonized Tripartate Guideline Q10
ICH Harmonized Tripartate Guideline Q2(R1)
ICH Harmonized Tripartate Guideline Q8(R2)
ICH Harmonized Tripartate Guideline Q9
Kengam S.K.
O'Brien N.A.
Pieters S.
Prinz H.
Rajan M.G.
Sheehan P.
Swarbrick B.
Warman M.
Publication venue
'IM Publications Open LLP'
Publication date
Field of study
No full text
Crossref
Application of DoE-Based Analytical QRM to Development of the Multipurpose RP-HPLC Method for Estimation of Multiple FDC Products of Telmisartan Using Enhanced AQbD Approach
Author
Altuntas
Delhiraj
+27Â more
Deshmukh
Deshmukh
Dinda
Ilango
Internation Council for Harmonisation (ICH) 10 Tripartite Guideline
Internation Council for Harmonisation (ICH) Q14 Guideline
Internation Council for Harmonisation (ICH) Q2(R1) Tripartite Guideline
Internation Council for Harmonisation (ICH) Q8(R2) Tripartite Guideline
Internation Council for Harmonisation (ICH) Q9 Tripartite Guideline
Jawla
Kayal
Kottai
Kranthi
Kumar
Maimoon
Marolia
Mounika
Nandipati
Patil
Rao
Sah
Simionato
Sirisha
Stanisz
Varghese
Vekariya
Yadav
Publication venue
'Oxford University Press (OUP)'
Publication date
Field of study
No full text
Crossref
Analytical Procedure Validation and the Quality by Design Paradigm
Author
Borman P.
Bruno Boulanger
+25Â more
Dewé W.
Eric Rozet
Ermer J.
ICH Q10
ICH Q2
ICH Q8
ICH Q9
Jean-François Michiels
Lebrun P.
Lionberger R. A.
Nethercote P.
Perceval Sondag
Peterson J. J.
Ph. Hubert
Ph. Hubert
Ph. Hubert
Pierre Lebrun
Rozet E.
Rozet E.
Rozet E.
Satterthwaite F. E.
Schweitzer M.
Tara Scherder
U.S. Food and Drug Administration (FDA)
United States Food and Drug Administration (FDA)
Publication venue
'Informa UK Limited'
Publication date
Field of study
No full text
Crossref
‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances
Author
Amandine Dispas
Andri
+49Â more
Borman
Borman
Bradley
Cédric Hubert
Del Castillo
Dispas
Furlanetto
Furlanetto
Goos
Hermane T. Avohou
Hubert
Hubert
Hubert
Hubert
Hubert
Hubert
ICH
ICH
ICH Q9
Karmarkar
Kormany
Lebrun
Lebrun
Maggio
Myers
Okafo
Orlandini
Orlandini
Orlandini
Orlandini
Orlandini
Pantovic
Pasquani
Patel
Peterson
Peterson
Peterson
Peterson
Philippe Hubert
Pierre Lebrun
Pohl
Rafamantanana
Rozet
Schmidt
Terzic
Tol
Tumpa
Vemic
Vogt
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
A Novel Liquid Chromatographic Method for the Quantitative Determination of Degradation Products in Remdesivir Injectable Drug product
Author
al-Tannak
Avataneo
+21Â more
Bilgin
Center for Drug Evaluation and Research (CDER)
ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
International Conference on Harmonization (ICH)
International Conference on Harmonization (ICH)
IUPAC
Liang
National Association of Testing Authorities Australia
Nebsen
Phenomenex Inc., 411 Madrid Ave., Torrance, CA 90501 USA
Saha
Shehan
Shimadzu Corporation
Sinha
Siva Kumar
U.S. Department of Health and Human Services Food and Drug Administration
USFDA
USP <
Warren
World Health Organization
Yan
Publication venue
'Oxford University Press (OUP)'
Publication date
Field of study
No full text
Crossref
A Quality By Design Approach For Longitudinal Quality Attributes
Author
Box G. E. P.
Bruno Boulanger
+21Â more
Deming W. E.
Eric Rozet
Guttman I.
ICH Q10
ICH Q8
ICH Q9
ICH-Q2R Guideline
Juran J. M.
Katherine Giacoletti
Peterson J. J.
Peterson J. J.
Peterson J. J.
Pierre Lebrun
Tara Scherder
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)
USP 32-NF 27 (2009)
Vaghela B.
Publication venue
'Informa UK Limited'
Publication date
Field of study
No full text
Crossref
Application of quality by design principles in the development and evaluation of semisolid drug carrier systems for the transdermal delivery of lidocaine
Author
Amelia Yip Anna Taddio
Anton
+43Â more
Babaei
Badawi
Barratt
Bhise
Castelli
Charoo
Claxton
Desai
Dierking
Doktorovova
Foldvari
Franz-Montan
Guo
H
ICH Q8
ICH Q9
Iwai
Jensen
Kligman
Kovacs
Kuchler
Loo
Makai
Moghadam
Muellergoymann
Muller
Nagarsenker
Pallagi
Pathak
Puglia
Puglia
Puglia
Raina
Ribeiro
Ricci
Shah
Thatipamula
Visser
Voelker-Pop
Wissing
Wissing
You
Zhang
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Intranasal delivery of venlafaxine loaded nanostructured lipid carrier: Risk assessment and QbD based optimization
Author
Abdelbary
Aburahma
+51Â more
Alam
Batrakova
Beg
Blasi
Brioschi
Chang
Coates
Costa
Dange
Das
Das
Djupesland
Fahmy
Fang
Florence
Gutierrez
Haque
He
Hippalgaonkar
Hu
ICH Q8 (R2)
ICH Q9
Illum
Illum
Iqbal
Jadhav
Jain
Jenning
Karn-orachai
Kasongo
Kilts
Kumar
Kumar
Kushwaha
Lawrence
Lenox
Mandpe
Muller
Müller
Negi
Nemeroff
Pund
Reddy
Seju
Souto
Stahl
Thakkar
Vora
Washington
Weiss
Wilson
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Human errors and measurement uncertainty
Author
Berglund B
Down M
+15Â more
Ellison S L R
Ellison S L R
Francesca Pennecchi
ICH Harmonized Tripartite Guidelines Q9
IEC/ISO 31010:2009
Ilya Kuselman
ISO 10012:2003
ISO 31000:2009
ISO Guide 73:2009
ISO/IEC 17025:2005
ISO/TS 22367:2008
JCGM 100:2008
JCGM 200:2012
Kuselman I
US Food
Publication venue
'IOP Publishing'
Publication date
Field of study
No full text
Crossref
Optimized chronomodulated dual release bilayer tablets of fexofenadine and montelukast: quality by design, development, and in vitro evaluation
Author
A Abebe
A Bashar
+35Â more
A Narang
A Uzunovic
AO Murtada
B Govedarica
B Shiyani
BG Shiyani
C Hildebrandt
G Thoorens
GM Cochrane
ICH Q9
ICHQ10
ICHQ8(R2)
J Ali
J Mitra
J Nirmal
J Xiongbin
M Turner-Warwick
MA Khan
MM Rahman
MR Hetzel
MS Gordon
N Yuksel
P Arefin
PE Silkoff
PM Desai
Q Zhou
RB Shah
RJ Huang
S Kitazawa
S Roychowdhury
SA Mandal
SK Vemula
T Ishikawa
U Dethlefsen
W Tak
Publication venue
'Springer Science and Business Media LLC'
Publication date
Field of study
No full text
Crossref
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