These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

307 related articles for article (PubMed ID: 22107128)

  • 1. Quality by design compliant analytical method validation.
    Rozet E; Ziemons E; Marini RD; Boulanger B; Hubert P
    Anal Chem; 2012 Jan; 84(1):106-12. PubMed ID: 22107128
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Validation of analytical methods involved in dissolution assays: acceptance limits and decision methodologies.
    Rozet E; Ziemons E; Marini RD; Boulanger B; Hubert P
    Anal Chim Acta; 2012 Nov; 751():44-51. PubMed ID: 23084050
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Methodology for the validation of analytical methods involved in uniformity of dosage units tests.
    Rozet E; Ziemons E; Marini RD; Boulanger B; Hubert P
    Anal Chim Acta; 2013 Jan; 760():46-52. PubMed ID: 23265732
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process.
    Hubert C; Lebrun P; Houari S; Ziemons E; Rozet E; Hubert P
    J Pharm Biomed Anal; 2014 Jan; 88():401-9. PubMed ID: 24176744
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Using tolerance intervals in pre-study validation of analytical methods to predict in-study results. The fit-for-future-purpose concept.
    Rozet E; Hubert C; Ceccato A; Dewé W; Ziemons E; Moonen F; Michail K; Wintersteiger R; Streel B; Boulanger B; Hubert P
    J Chromatogr A; 2007 Jul; 1158(1-2):126-37. PubMed ID: 17420025
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process.
    Liu DQ; Chen TK; McGuire MA; Kord AS
    J Pharm Biomed Anal; 2009 Sep; 50(2):144-50. PubMed ID: 19427156
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Evaluating the reliability of analytical results using a probability criterion: a Bayesian perspective.
    Rozet E; Govaerts B; Lebrun P; Michail K; Ziemons E; Wintersteiger R; Rudaz S; Boulanger B; Hubert P
    Anal Chim Acta; 2011 Oct; 705(1-2):193-206. PubMed ID: 21962362
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Flexibility and applicability of β-expectation tolerance interval approach to assess the fitness of purpose of pharmaceutical analytical methods.
    Bouabidi A; Talbi M; Bourichi H; Bouklouze A; El Karbane M; Boulanger B; Brik Y; Hubert P; Rozet E
    Drug Test Anal; 2012 Dec; 4(12):1014-27. PubMed ID: 22615163
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Do placebo based validation standards mimic real batch products behaviour? Case studies.
    Bouabidi A; Talbi M; Bouklouze A; El Karbane M; Bourichi H; El Guezzar M; Ziemons E; Hubert P; Rozet E
    J Pharm Biomed Anal; 2011 Jun; 55(3):583-90. PubMed ID: 21377822
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept.
    Bouabidi A; Rozet E; Fillet M; Ziemons E; Chapuzet E; Mertens B; Klinkenberg R; Ceccato A; Talbi M; Streel B; Bouklouze A; Boulanger B; Hubert P
    J Chromatogr A; 2010 May; 1217(19):3180-92. PubMed ID: 19733857
    [TBL] [Abstract][Full Text] [Related]  

  • 11. A Process Analytical Technology (PAT) approach to control a new API manufacturing process: development, validation and implementation.
    Schaefer C; Clicq D; Lecomte C; Merschaert A; Norrant E; Fotiadu F
    Talanta; 2014 Mar; 120():114-25. PubMed ID: 24468350
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Setting acceptance criteria for validation of analytical methods of drug eluting stents: Minimum requirements for analytical variability.
    Kamberi M; Garcia H; Feder DP; Rapoza RJ
    Eur J Pharm Sci; 2011 Feb; 42(3):230-7. PubMed ID: 21126583
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products.
    Boussès C; Ferey L; Vedrines E; Gaudin K
    J Pharm Biomed Anal; 2015 Nov; 115():114-22. PubMed ID: 26183807
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal part IV. Examples of application.
    Hubert P; Nguyen-Huu JJ; Boulanger B; Chapuzet E; Cohen N; Compagnon PA; Dewé W; Feinberg M; Laurentie M; Mercier N; Muzard G; Valat L; Rozet E
    J Pharm Biomed Anal; 2008 Nov; 48(3):760-71. PubMed ID: 18768284
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Validation in pharmaceutical analysis. Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data.
    Ermer J; Ploss HJ
    J Pharm Biomed Anal; 2005 Apr; 37(5):859-70. PubMed ID: 15862659
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Use of a quality-by-design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols.
    Skrdla PJ; Wang T; Antonucci V; Dowling T; Ge Z; Ellison D; Curran J; Mohan G; Wyvratt J
    J Pharm Biomed Anal; 2009 Dec; 50(5):794-6. PubMed ID: 19596534
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.
    Badawy SI; Narang AS; LaMarche KR; Subramanian GA; Varia SA; Lin J; Stevens T; Shah PA
    J Pharm Sci; 2016 Jan; 105(1):168-81. PubMed ID: 26852852
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product.
    Peinado A; Hammond J; Scott A
    J Pharm Biomed Anal; 2011 Jan; 54(1):13-20. PubMed ID: 20801599
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Analytical control of process impurities in Pazopanib hydrochloride by impurity fate mapping.
    Li Y; Liu DQ; Yang S; Sudini R; McGuire MA; Bhanushali DS; Kord AS
    J Pharm Biomed Anal; 2010 Aug; 52(4):493-507. PubMed ID: 20189340
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Analytical procedure validation and the quality by design paradigm.
    Rozet E; Lebrun P; Michiels JF; Sondag P; Scherder T; Boulanger B
    J Biopharm Stat; 2015; 25(2):260-8. PubMed ID: 25357001
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 16.