Biological assessment tool

Southerland MT, Stribhng JB. 1995. Status of biological criteria development and implementation. In Davis WS, Simon TP, editors. Biological assessment and criteria tools for water resource planning and decision making. Boca Raton (FL) Lewis Pubhshers, p. 81-96. 

This FDA IND review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Center for Drug Evaluation and Research (CDER) and the Center for Biologies Evaluation and Research (CBER) to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

The activities of the bank should be conducted following a set of standard operating procedures such as those provided by the International Society of Biological and Environmental Repositories (ISBER) (26) (see Note 7). In addition to the ISBER, the American Association of Tissue Banks (AATB) provides guidance for standard operating procedures in its Self-assessment Tool/Audit Report (STAR) for therapeutic tissue and reproductive banks, Section B, General Organizational Requirements of a Tissue Bank (27). 

Biological assessment of the direct and indirect mutagenicity of PAH is well characterized and is a valuable tool... 

Assessment tools used in ecotoxicology range from toxicity tests (link the response of damaged biological systems to a particular substance), chemical analyses of substances (proof of the presence of a toxicant), and field surveys (characteristics of the damaged ecosystem). These three tools help in the assessment of risk. Indirect effects of toxicants are more difficult to predict. For example, an organism s response to a toxicant depends on the presence of other organisms in the community and also on the environmental conditions. Most of the relationships between environmental conditions and toxicity have yet to be established. 

A biomarker is here defined as a biological response to an environmental chemical at the individual level or below, which demonstrates a departure from normality. Responses at higher levels of biological organization are not, according to this definition, termed biomarkers. Where such biological responses can be readily measnred, they may provide the basis for biomarker assays, which can be nsed to stndy the effects of chemicals in the laboratory or, most importantly, in the field. There is also interest in their employment as tools for the environmental risk assessment of chemicals. 

Information on exposure levels is fundamental for the assessment and management of health risks related to occupational and environmental exposure to pesticides. Biological monitoring is a primary tool for exposure evaluation,... 

There is a growing need to better characterize the health risk related to occupational and environmental exposure to pesticides. Risk characterization is a basic step in the assessment and management of the health risks related to chemicals (Tordoir and Maroni, 1994). Evaluation of exposure, which may be performed through environmental and biological monitoring, is a fundamental component of risk assessment. Biomarkers are useful tools that may be used in risk assessment to confirm exposure or to quantify it by estimating the internal dose. Besides their use in risk assessment, biomarkers also represent a fundamental tool to improve the effectiveness of medical and epidemiological surveillance. 

Mass spectrometry has become one of the most important tools for analyzing proteins in complex biological samples. The ability to separate proteins and peptides in high resolution has made possible the simultaneous identification of hundreds of proteins within samples (for reviews, see Gingras et al., 2005 Hamdan and Righetti, 2005 Siuzdak, 2006). Proteins can be analyzed for their presence or compared between samples for their relative expression level. One cell population treated with a drug candidate, for instance, can be compared by mass spec to another sample as control to assess the affect of the drug on expression levels of certain proteins. 

In the light of these limitations, effective additional tools able to assess the biological responses of the pesticides present, as well as their interaction with the other chemicals, have to be introduced to complete the evaluation of waste-waters. Bioassays on water samples provide a direct functional response that can relate to the negative effects of a single pesticide and overall toxic properties of the complex mixture of compounds present in a sample [16]. 

Connally, R. and Anderson, M. (1991). Biologically based pharmacokinetic models Tools for toxicological research risk assessment. Annu. Rev. Pharmacol. Toxicol. 31 503-523. 

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