[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 …

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

[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 …

[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 (…

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 …

A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development

MN Martinez, F Wu, B Sinko, DJ Brayden, M Grass… - The AAPS Journal, 2022 - Springer
… 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. …

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. …

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. …

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 biologicalbiological sex influences cultural
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 …