Literature DB >> 23425265

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.

Xiao-Yan Cai, Ashleigh Wake, Dominique Gouty.   

Abstract

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Year:  2013        PMID： 23425265     DOI： 10.4155/bio.13.1

Source DB:  PubMed          Journal:  Bioanalysis        ISSN： 1757-6180            Impact factor:   2.681


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  10 in total

Review 1.  Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment.

Authors:  D Gouty; C C Cai; X Y Cai; A Kasinath; V Kumar; S Alvandkouhi; J Yang; S Pederson; B Babbitt; D Peritt; A Rudy; V Koppenburg; A Dasilva; M Ullmann; S Liu; C Satterwhite
Journal:  AAPS J       Date:  2017-12-28       Impact factor: 4.009

2.  Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.

Authors:  Francesca Civoli; Aparna Kasinath; Xiao-Yan Cai; Meenu Wadhwa; Andrew Exley; Philip Oldfield; Safa Alvandkouhi; Gregor Schaffar; John Chappell; Ronald Bowsher; Viswanath Devanarayan; Joseph Marini; Shannon Rebarchak; Michael Anderson; Vera Koppenburg; Todd Lester
Journal:  AAPS J       Date:  2019-12-02       Impact factor: 4.009

3.  Physicochemical Characterization of Altebrel™, a Proposed Etanercept Biosimilar.

Authors:  Ramin Fazel; Fereidoun Mahboudi; Ehsan Seyedjafari; Soroush Sardari; Behrouz Vaziri
Journal:  Iran J Biotechnol       Date:  2019-12-01       Impact factor: 1.671

4.  Harnessing biomolecules for bioinspired dental biomaterials.

Authors:  Nicholas G Fischer; Eliseu A Münchow; Candan Tamerler; Marco C Bottino; Conrado Aparicio
Journal:  J Mater Chem B       Date:  2020-08-04       Impact factor: 6.331

5.  Barriers to the Use of Trastuzumab for HER2+ Breast Cancer and the Potential Impact of Biosimilars: A Physician Survey in the United States and Emerging Markets.

Authors:  Philip Lammers; Carmen Criscitiello; Giuseppe Curigliano; Ira Jacobs
Journal:  Pharmaceuticals (Basel)       Date:  2014-09-17

6.  Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs.

Authors:  Alex Colbert; Amber Umble-Romero; Samantha Prokop; Vincent Fung-Sing Chow; Teresa Wong; Danielle DeSimone; Lei Zhou; Susan Pederson
Journal:  MAbs       Date:  2014       Impact factor: 5.857

7.  A Reference Standard for Analytical Testing of Erythropoietin.

Authors:  Huiping Tu; Kevin Carrick; Rebecca Potts; Mark Hasselberg; Mark Verdecia; Chris Burns; Ben Cowper; Fouad Atouf
Journal:  Pharm Res       Date:  2022-03-15       Impact factor: 4.200

8.  Trends in anti-HER2 drugs consumption and influencing factors.

Authors:  Jie Liu; Xiaolei Zhang; Biao Wang; Huizhen Dai; Dahai Dou; Wentong Fang
Journal:  Front Public Health       Date:  2022-09-08

9.  Investigation of purification process stresses on erythropoietin peptide mapping profile.

Authors:  Mina Sepahi; Hooman Kaghazian; Shahin Hadadian; Dariush Norouzian
Journal:  Adv Biomed Res       Date:  2015-05-29

10.  Barriers to the Access and Use of Rituximab in Patients with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia: A Physician Survey.

Authors:  William H Baer Ii; Archana Maini; Ira Jacobs
Journal:  Pharmaceuticals (Basel)       Date:  2014-05-07
  10 in total

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