[PDF][PDF] 'Generic'or 'follow-on'biologics: scientific considerations and safety issues
JD Green, L Tsang, JA Cavagnaro - Expert Opinion on Biological …, 2003 - Taylor & Francis
… not to the product’s safety or biologic activity profile. These above noted considerations
clearly differentiate the manufacture and analytical challenges for biologic therapeutics from the …
clearly differentiate the manufacture and analytical challenges for biologic therapeutics from the …
2.2 Theoretical Considerations for the Biological Effects of Electromagnetic Fields
DJ Panagopoulos, LH Margaritis - Biological Effects of …, 2013 - books.google.com
… of linear relationship between cause and effect and absence of totally … biological effects
cannot be simply explained by temperature increase inside the exposed tissues,(" thermal effects…
cannot be simply explained by temperature increase inside the exposed tissues,(" thermal effects…
[HTML][HTML] Ethical and philosophical consideration of the dual-use dilemma in the biological sciences
S Miller, MJ Selgelid - Science and engineering ethics, 2007 - Springer
… Here, as elsewhere, the devil is in the detail, and there is a need for specific policies to be
framed in the light of a range of human rights, academic and scientific considerations as well …
framed in the light of a range of human rights, academic and scientific considerations as well …
[HTML][HTML] Scientific Considerations
AC Mastroianni, R Faden… - Women and Health …, 1994 - ncbi.nlm.nih.gov
… Differences can arise from a range of factors, both biological (eg, the effect of endogenous
or exogenous hormones or gender-related differences in body mass, etc.) and psychosocial (…
or exogenous hormones or gender-related differences in body mass, etc.) and psychosocial (…
Scientific considerations for evaluating cancer bioassays conducted by the Ramazzini Institute
JS Gift, JC Caldwell, J Jinot, MV Evans… - Environmental …, 2013 - ehp.niehs.nih.gov
… In regard to the evaluation of RI cancer bioassays, we have identified several considerations
to support interpretation of RI results (summarized in Table 4) that take into account the …
to support interpretation of RI results (summarized in Table 4) that take into account the …
A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development
… is how these biological effects are evaluated. Therefore, in Part 2 of this critical overview,
the in vitro, in vivo, and in silico methods for evaluating excipient effects are considered. …
the in vitro, in vivo, and in silico methods for evaluating excipient effects are considered. …
Thermal modification of connective tissues: basic science considerations and clinical implications
SP Arnoczky, A Aksan - JAAOS-Journal of the American Academy …, 2000 - journals.lww.com
… joint, there have been numerous in vitro and in vivo studies that characterize the biomechanical
and biologic effect of thermal modification on tendons, ligaments, and the joint capsule. …
and biologic effect of thermal modification on tendons, ligaments, and the joint capsule. …
Scientific and regulatory considerations on the immunogenicity of biologics
G Shankar, E Shores, C Wagner, A Mire-Sluis - Trends in biotechnology, 2006 - cell.com
… This article focuses on the biological products that are used therapeutically, for which an
immune response is not an … Continued study might reveal the biological effects of neutralization. …
immune response is not an … Continued study might reveal the biological effects of neutralization. …
Women's underrepresentation in science: sociocultural and biological considerations.
SJ Ceci, WM Williams, SM Barnett - Psychological bulletin, 2009 - psycnet.apa.org
… Here we address the mechanism by which biological … biological sex influences cultural
expectations and, consequently, indirectly affects the other outer ring factors. However, biology …
expectations and, consequently, indirectly affects the other outer ring factors. However, biology …
Critical biological pathways for chronic psychosocial stress and research opportunities to advance the consideration of stress in chemical risk assessment
BS McEwen, P Tucker - American Journal of Public …, 2011 - ajph.aphapublications.org
… may be to lower the threshold at which physical exposures affect biological and clinical
outcomes.” Increased susceptibility to the effects of traffic-related pollution and in utero tobacco …
outcomes.” Increased susceptibility to the effects of traffic-related pollution and in utero tobacco …
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