Strategy and Risk Assessment

In particular, parallel optimization of affinity/selectivity and pharmacokinetic properties are difficult to achieve, especially if several PK parameters need to be 

Affinity, seiectivity, safety, physicochem, ADME incl. CYP450 inhibition, bioavailability 

---

Air Pollution Control Strategies and Risk Assessments for Tropospheric Ozone and Associated Photochemical Oxidants, Acids, Particles, and Hazardous Air Pollutants... 

Risk assessment The process by which results of a risk analysis are used to make decisions, either through a relative ranking of risk reduction strategies or through comparison with risk targets. The terms risk analysis and risk assessment are often used interchangeably in the literature. 

From a regulatory standpoint, the FDA s concern regarding safety involves the toxicity, degradants, and impurities of excipients, as discussed in other chapters in this book. In addition, other chapters of this book address types of toxicity concerns, toxicity testing strategies, and exposure and risk assessment of excipients. 

The remaining parts of this chapter will provide detailed information about each of these six steps. However, specific strategies for risk assessment and management may need additional elements, depending on the nature of the hazard, the foods in which it may occur and other specific conditions. For example, some additives may also occur as natural constituents in the diet or may be chemically altered when they come into contact with food components. For such substances a unique approach may need to be developed. 

In order to reduce animal testing under REACH, and also because of the ban on the marketing of cosmetic products/ingredients tested on animals, a broader strategy for risk assessment has been suggested. One element suggested in this strategy is the TTC concept. 

It is concluded that the TTC concept for systemic toxicity is suitable as a starting point for a tiered testing and risk assessment strategy within REACH. However, it is also underlined that the... 

Naghavi M, Libby P Falk E, et al. From vulnerable plaque to vulnerable patient a call for new definitions and risk assessment strategies Part I, Circulation 20037 108(14) 1664-1672. 

STRATEGIES FOR RISK ASSESSMENT THE CHOICE AND USE OF TEST SYSTEMS TO ESTIMATE HUMAN GERMINAL MUTATION... 

STRATEGIES FOR RISK ASSESSMENT RELATION BETWEEN MUTATION RATE AND HUMAN WELFARE... 

The special vulnerability of children should form the basis for development of child-protective policies and risk assessment approaches. A lack of lull proof for causal associations should not prevent efforts to reduce exposures or implement intervention and prevention strategies. 

When defining predictivity criteria, the proposed application of the QSAR should also be taken into account, to accommodate the consequences of making incorrect (or inaccurate) predictions. In principle, QSARs can be used for the priority setting of chemicals, or as components in hazard and risk assessment strategies. In such strategies, QSARs could serve as (partial) replacements of animal experiments, or as screening methods for selecting the experimental tests that need to be conducted. 

---