1
TITLE: Immunogenicity of mAbs in non-human primates during nonclinical safety assessment
AUTHORS: Peter J K van Meer; Marlous Kooijman; Vera Brinks; Christine C Gispen de Wied; Beatriz Silva Lima ; Ellen H M Moors; Huub Schellekens;
PUBLISHED: 2013, SOURCE: MABS, VOLUME: 5, ISSUE: 5
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
2
TITLE: Insights on the safety of carotenogenic Chlorella vulgaris in rodents  Full Text
AUTHORS: Cristina de Mello Sampayo; Luisa L Corvo ; Rogerio Mendes; Diana Duarte; Joana Lucas; Rui Pinto; Ana Paula Batista; Anabela Raymundo ; Beatriz Silva Lima ; Narcisa M Bandarra; Luisa Gouveia;
PUBLISHED: 2013, SOURCE: ALGAL RESEARCH-BIOMASS BIOFUELS AND BIOPRODUCTS, VOLUME: 2, ISSUE: 4
INDEXED IN: Scopus WOS
IN MY: ORCID
3
TITLE: Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines  Full Text
AUTHORS: Falk Ehmann; Kumiko Sakai Kato; Ruth Duncan; Dolores Hernan Perez de la Ossa; Ruben Pita; Jean Marc Vidal; Ashish Kohli; Laszlo Tothfalusi; Alan Sanh; Sandrine Tinton; Jean Louis Robert; Beatriz Silva Lima ; Marisa Papaluca Amati;
PUBLISHED: 2013, SOURCE: NANOMEDICINE, VOLUME: 8, ISSUE: 5
INDEXED IN: Scopus WOS CrossRef: 59
IN MY: ORCID
4
TITLE: Pediatric Drug Development Plans
AUTHORS: Brannen, KC; Lima, BS ;
PUBLISHED: 2012, SOURCE: Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices
INDEXED IN: Scopus CrossRef
IN MY: ORCID
5
TITLE: Scientific considerations for complex drugs in light of established and emerging regulatory guidance. Scientific considerations for complex drugs  Full Text
AUTHORS: Chris Holloway; Jan Mueller Berghaus; Beatriz Silva Lima ; Sau (Larry) Lee; Janet S Wyatt; Michael M Nicholas; Daan J A Crommelin;
PUBLISHED: 2012, SOURCE: ANNALS MEETING REPORTS 2013, VOLUME: 1276, ISSUE: 1
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
6
TITLE: Juvenile Animal Studies in the Development of Pediatric Medicines: Experience from European Medicines and Pediatric Investigation Plans  Full Text
AUTHORS: Dinah M Duarte; Beatriz Silva Lima ;
PUBLISHED: 2011, SOURCE: BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY, VOLUME: 92, ISSUE: 4
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
7
TITLE: Value of Juvenile Animal Studies. VALUE OF JUVENILE ANIMAL STUDIES: A WORKSHOP  Full Text
AUTHORS: Isabelle Leconte; Graham Bailey; Karen Davis Bruno; Kok Wah Hew; James Kim; Beatriz Silva Lima ; Ulla Liminga; Jeffrey Moffit; Luc De Schaepdrijver; Georg Schmitt; Melissa Tassinari; Kary Thompson; Mark Hurtt;
PUBLISHED: 2011, SOURCE: BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY, VOLUME: 92, ISSUE: 4
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
8
TITLE: In vitro cytokine release assays for predicting cytokine release syndrome: The current state-of-the-science. Report of a European Medicines Agency Workshop  Full Text
AUTHORS: Vidal, JM; Kawabata, TT; Thorpe, R; Silva Lima, B ; Cederbrant, K; Poole, S; Mueller Berghaus, J; Pallardy, M; Van der Laan, JW;
PUBLISHED: 2010, SOURCE: Cytokine, VOLUME: 51, ISSUE: 2
INDEXED IN: Scopus CrossRef
IN MY: ORCID
9
TITLE: Juvenile Animal Studies for the Development of Paediatric Medicines: A Description and Conclusions From a European Medicines Agency Workshop on Juvenile Animal Testing for Nonclinical Assessors  Full Text
AUTHORS: Beatriz Silva Lima ; Mette Due Theilade Thomsen; Jacqueline Carleer; Jean Marc Vidal; Paolo Tomasi; Agnes Saint Raymond;
PUBLISHED: 2010, SOURCE: BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY, VOLUME: 89, ISSUE: 6
INDEXED IN: Scopus WOS
IN MY: ORCID
10
TITLE: Renal biomarker qualification submission: A dialog between the FDA-EMEA and Predictive Safety Testing Consortium  Full Text
AUTHORS: Dieterle, F; Sistare, F; Goodsaid, F; Papaluca, M; Ozer, JS; Webb, CP; Baer, W; Senagore, A; Schipper, MJ; Vonderscher, J; Sultana, S; Gerhold, DL; Phillips, JA; Maurer, G; Carl, K; Laurie, D; Harpur, E; Sonee, M; Ennulat, D; Holder, D; Andrews Cleavenger, D; Gu, YZ; Thompson, KL; Goering, PL; Vidal, JM; Abadie, E; MacIulaitis, R; Jacobson Kram, D; Defelice, AF; Hausner, EA; Blank, M; Thompson, A; Harlow, P; Throckmorton, D; Xiao, S; Xu, N; Taylor, W; Vamvakas, S; Flamion, B; Lima, BS ; Kasper, P; Pasanen, M; Prasad, K; Troth, S; Bounous, D; Robinson Gravatt, D; Betton, G; Davis, MA; Akunda, J; McDuffie, JE; Suter, L; Obert, L; Guffroy, M; Pinches, M; Jayadev, S; Blomme, EA; Beushausen, SA; Barlow, VG; Collins, N; Waring, J; Honor, D; Snook, S; Lee, J; Rossi, P; Walker, E; Mattes, W; ...More
PUBLISHED: 2010, SOURCE: Nature Biotechnology, VOLUME: 28, ISSUE: 5
INDEXED IN: Scopus CrossRef
IN MY: ORCID
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