Regulatory objectives

Educating consumers about the efficacy, safety, quality and rational use of dmgs can also enhance the achievement of regulatory objectives. 

An obvious and all-important aspect of Section 8 is that it is a mechanism to facilitate the acquisition of information that EPA needs. Accordingly, the proper test of EPA s performance under Section 8 is not the amount of information that EPA acquires or the number of companies required to report, but the Agency s success in building a data-base for accomplishing its specific risk assessment, testing and chemical control responsibilities under Sections 4, 5, 6 and 7 of TSCA. In view of this purpose, it was of great concern that EPA has repeatedly failed to define carefully, and then articulate fully, the connection between a proposal under Section 8, and a specific regulatory objective under some other provision of TSCA. 

Monitor and evaluate performance to assess if perceived regulatory objectives have been met, to identify weaknesses and take corrective action... 

The Japanese Air Pollution Control Law dates back to 1968 and was designed to promote comprehensive air pollution control measures. Subsequent revisions have included extensions of regulatory objects, nationwide regulation and enforced standards, e.g. those for specific dust (asbestos) in 1989, vehicle fuel in 1995, harmful air pollutants in 1996 and volatile organic compounds (VOC) in 2004. Article 1 of the recent Japanese Air Pollution Control Law [16] states ... 

Emphasis is placed on preparing a validation protocol in which the specific validation experiments and associated acceptance criteria substantiate that the method meets its technical and regulatory objectives. Only after these steps does the process conclude with the performance of the formal validation and generation of the validation report. Finalization of method development (by way of the method validation) is never truly complete, as validation is aliving process that encompasses the ongoing use of the method in various laboratory settings. 

Ultimately the technical objective of an analytical procedure, which is included as part of a registration application for pharmaceuticals, is the responsibility of the analytical department. This objective is directly related to the regulatory objective as defined by the regulatory professionals. For example, the regulatory professionals require a means to quantitate an API in a finished pharmaceutical for release between 95-105% of label claim. This translates into a technical objective for the analytical chemist that involves the selection of an analytical technique and the development of a method that has the required accuracy and precision to meet the requirements for release. 

Pharmacokinetic Measures of Systemic Exposure Both direct (e.g., rate constant, rate profile) and indirect (e.g., Cmax, Tmax, mean absorption time, mean residence time, Cmax normalized to AUC) pharmacokinetic measures are limited in their ability to assess rate of absorption. This guidance, therefore, recommends a change in focus from these direct or indirect measures of absorption rate to measures of systemic exposure. Cmax and AUC can continue to be used as measures for product quality BA and BE, but more in terms of their capacity to assess exposure than their capacity to reflect rate and extent of absorption. Reliance on systemic exposure measures should reflect comparable rate and extent of absorption, which in turn should achieve the underlying statutory and regulatory objective of ensuring comparable therapeutic effects. Exposure measures are defined relative to early, peak, and total portions of the plasma, serum, or blood concentration-time profile, as follows ... 

Why has this elegant reaction theory not been applied to general reactive systems with many DOFs It was because their algorithm depends crucially on finding pure unstable periodic orbits in the nonreactive degrees of freedom. As pointed out previously [44], it is always possible to find this regulatory object in... 

The United Nations Economic Commission for Europe (UN/ECE) model, with its Common Regulatory Objective, international standards to be referenced and conformity assessment procedures provides a possible framework for the establishment of equivalence. 

CAA (1999). Regulatory Objective for Software Safety Assurance in Air Traffic Service Equipment SWOl. Civil Aviation Authority, UK, 1999 Lipshitz R Strauss O (1997). Coping with Uncertainty A Naturalistic Decision-Making Analysis. Organizational Behaviour and Human Decision Processes 1997 69-2 149-163... 

---