Regulatory Perspective

Currently, a battery of studies are required as a condition of registration primarily involving analysis of active ingredient and major metabolites in soil or water media. 

Handbook of Residue Analytical Methods for Agrochemicals. 2003 John Wiley Sons Ltd. 

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S. Albu, "California s Regulatory Perspective on Alternate Euels," 13th North American Motor Vehicle Emissions Control Conf (Tampa, Fla., Dec. 11—14, 1990), Mobile Source Division, California Air Resources Board, El Monte, Calif. 

Ref. 4 presents a useful survey of the process of dmg development from the regulatory perspective. 

Drugs are classified from a regulatory perspective, as either over-the-counter (OTC) or prescription-only medicines (POM, or Rx in America). Human medicines are subject to medical prescription where they... 

Safety and quality aspects are the main topics that must be addressed from a regulatory perspective at the pre-clinical phase of drug development. Indicative efficacy data will also be obtained, but authoritative data can be obtained only from clinical studies conducted with humans. Safety and preliminary efficacy indications... 

E. E. Fant. Odorization—a regulatory perspective. In Odorization, volume 3, pages 109-118. Institute of Gas Technology, Chicago, IL, 1993. 

Lesko, L. Woodcock, J. (2002). Pharmacogenetic-guided drug development regulatory perspective. Pharmacogenomics /., 2, 20-4. 

Hussain, A. S., Methods for permeability determination A regulatory perspective. AAPS Workshop on Permeability Definitions and Regulatory Standards for Bioequivalence, Arlington, VA, Aug. 17-19, 1998. 

Lesko, L., and J. Woodcock, "Pharmacogenomic-Guided Drug Development Regulatory Perspective Pharmacogenomics" (in press). 

Cleanup strategies for hydrocarbon-affected soil will most likely be the last issue to be mandated from a regulatory perspective and certainly the most difficult technically to address. This difficulty reflects the large, deep-seated volumes of residual hydrocarbon present, and the current lack of efficient, cost-effective methodologies for in situ remediation of residual hydrocarbons in low-permeability, fine-grained soils. 

Shah VP, Williams RL. In vivo and in vitro correlations scientific and regulatory perspectives. Generics Bioequivalence 2000 6 101-110. 

Regulatory Perspectives on Pharmacogenetics and Pharmacogenomics 11.8.1 Safe Harbor... 

Bakke, O.M., Manocchia, M., de Abajo, R, Kaitin, K.I., and Lasagna, L., Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993 a regulatory perspective, Clin. Pharmacol. Then, 58, 108-117, 1995. 

Chain of custody is an important issue for investigators to address for physical data. This is a concern not only from a legal and regulatory perspective, but is a good practice designed to ensure that testing is per-... 

With increasing toxicity data of various kinds, more rehable predictions based on structure-toxicity relationships of toxic endpoints can be attempted [31-36]. Even the Internet can be used as a source for toxicity data, albeit with caution [37]. A number of predictive methods have been compared from a regulatory perspective [35]. Often traditional QSAR approaches using multiple Hnear regression are used [38]. Newer approaches include the use of neural networks in structure-toxicity relationships... 

Rauws AG. Bioequivalence a European Community regulatory perspective. In Welling PG, Tse ELS, Dighe SV, eds. Pharmaceutical Bioequivalence. New York Marcel Dekker, 1991 419 2. 

Cutler NR, Sramek J, Greenblatt DJ, et al. Defining the maximum tolerated dose investigator, academic, industry and regulatory perspectives. J Clin Pharmacol 1997 37 767-83. 

Strong, J. and Huang, S. (2008) U.S. regulatory perspective drug-drug... 

Juhl, R. P. 2000. Prescription to Over-the-Counter Switch A Regulatory Perspective. Clinical Therapeutics 20(Supp. C) l 11-117. 

From a regulatory perspective, an observed developmental toxic finding is considered to be of potential human relevance (even if it is mediated via maternal pharmacological effects or occur at doses causing signs of maternal toxicity) unless the company can provide appropriate mechanistic and/or other convincing evidence to the contrary. 

Typically, later phase trials tend to have the confirmatory elements while the earlier phase studies proof of concept, dose-finding etc. are viewed as exploratory. Indeed an alternative word for confirmatory is pivotal. It is the confirmatory elements of our trials that provide the pivotal information from a regulatory perspective. 

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