Regulatory decision-making

In Estonia, however, regulatory action is not taken on the basis of ADR reports sent by health professionals. This is because the SAM considers that the small number of reports made in Estonia forms an inadequate basis for regulatory decision-making. 

In the past few years a variety of workshops and symposia have been held on the subjects of model verification, field validation, field testing, etc. of mathematical models for the fate and transport of chemicals in various environmental media. Following a decade of extensive model development in this area, the emphasis has clearly shifted to answering the questions "How good are these models ", "How well do they represent natural systems ", and "Can they be used for management and regulatory decision-making "... 

Risk Assessment. What is the incidence of the adverse health effects from the chemical agent This crucial question for regulatory decision making might be answered by combining the unit risk assessment with the exposure assessment. As In the exposure assessment, the question must be addressed in the context of one or more specific control policies. 

Improving the Quality of Science in Regulatory Decision Making and Science Advise in the United States (HARRISON Myron, USA)... 

Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision-Making Report of the First FDA-PWG-PhRMA-DruSafe Workshop.199... 

Originally published by Lesko L.J., Salerno R.A., Spear B.B. et al., as Pharmacogenetics and pharmacogenomics in drug development and regulatory decision-making Report of the First FDA-PWG-PhRMA-DruSafe Workshop. ]. Clin. Pharmacol., 43, 342-358, 2003.)... 

The workshop concluded with a panel discussion, along with questions and answers from the audience related to future deployment of pharmacogenetics and pharmacogenomics in drug development and regulatory decision-making. The broad conclusions from the workshop are as follows ... 

Lesko, L.J. and Atkinson, A.J., Jr., Biomarkers and surrogate endpoints — Use in drug development and regulatory decision making criteria, validation, strategies, Ann. Rev. Pharmacol. Toxicol, 41, 347-366, 2001. 

A review made by ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals, an industry-financed scientific fomm) on the use of (Q)SARs within current regulatory decision-making frameworks in EU, North America, and Japan, and within industry concluded that applicability of currently available (Q)SARs for chronic mammalian toxicity, certainly as a stand-alone approach, was very limited at that time (ECETOC 2003). 

These problems cause delays in regulatory decision making, which have significant implications for all the stakeholders. 

A high degree of sensitivity of in vitro dissolution tests to formulation differences raises questions about the appropriate acceptance criteria—how similar should two in vitro dissolution profiles be to be considered similar The SUPAC-IR introduced to the regulatory decision-making process a metric referred to as f2 [43] for profile comparison. Application of this criterion to the examples cited in this report (e.g., piroxicam formulations) would have resulted in a recommendation for the in vivo bioequivalence study. 

Hales, S.G., T. Feijtel, H. King, K. Fox, and W. Verstraete. 1997. Biodegradation Kinetics Generation and Use of Data for Regulatory Decision Making. SETAC-Europe Workshop - Port-Sunlight, UK 4-6 Sept. 1996, SETAC-Europe Brussels. 

CRARM (1997). Commission on Risk Assessment and Risk Management. Risk Assessment and Risk Management in Regulatory Decision Making, Final Report (Presidential/Congressional Commission on Risk Assessment and Risk Management, Washington). 

MUNRO, I.C. and KREWSKI, D.R. (1981). Risk assessment and regulatory decision making, Food Cosmet. Toxicol. 19, 549-560. 

Salerno RA, Lesko LJ. Pharmacogenomics in drug development and regulatory decision-making the genomic data submission (GDS) proposal. Pharmacogenomics 2004 5(l) 25-30. 

I am indebted to many scientists across the globe for their input into the chapter, provision of information and references, and general stimulation of my interest in this application of QSAR. In particular, I would like to thank Mike Comber, Joanna Jaworska, John Walker, Chris Watts, Andrew Worth, and Maurice Zeeman. Further, I acknowledge the hard work, effort, and dedication of many scientists and civil servants worldwide who have endeavored to apply QSAR methods to regulatory decision-making processes. 

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