New Approach Methods (NAMs) and lntegrated Approaches to Testing and Assessment (IATA)
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The guest lecture / presentation focused on how various data streams used in evidence integration for risk assessment can be better integrated through use of mechanistic constructs, including source to outcome modeling with dosimetry providing the critical link between aggregate exposure pathway (AEP) and adverse outcome pathway (AOP) frameworks. Emphasis was placed on the need to create context for the use of new approach methods (NAMs) by advancing integrated approaches to testing and assessment (IATA) with some examples for inhalation exposures for two chemical categories (PSLT and surfactants) under TSCA Section 5. The need for reporting standards as a roadmap for translation was emphasized. Specific learning objectives included the following: Appreciate challenges of evidence integration; Define AEP and AOP: with a Depiction of processes and data organization; Discuss transitions and translations in modernizing risk assessment; Introduce NAMs and defined approaches (DAs); Distinguish empirical models from mechanistic constructs; Provide basic understanding of inhalation dosimetry models; Convey relationships among NAMs, DAs and IATAs; Consider confidence building strategies; Present role for reporting standards and Encourage innovation in experimental designs.