Efficacy of products

Panehsts are trained to evaluate malodor intensity and the degree of modification. It is important that the paneflst be able to smell through any extraneous odor(s), such as the fragrance of the product, to evaluate the efficacy of products making elimination or neutralization claims, as opposed to the phenomenon of masking. 

The proposed review of PLRs was already considered necessary by the United Kingdom but became a requirement when it joined the European Union. It was to correspond to the requirements under Directives 65/65/EEC and 75/318/EEC of the European Community that required that, throughout the Community, proprietary medicinal products granted licences before 22 November 1976 should be reviewed by 20 May 1990. All Member States of the European Community were similarly required to review the quality, safety and efficacy of products on their market. 

The records-keeping requirements to demonstrate the safety and efficacy of products are also applicable for persons exporting human drags, biological products, devices, animal drags, food, and cosmetics that may not be marketed or sold in the United States.1... 

This rapidly growing market is very competitive. Companies in this area must be highly innovative to be successful. There are key determinant factors that should be optimized for competitive innovation (a) product development should be shortened by accelerating clinical trials (b) well-protected intellectual property should be built and maintained (c) the efficacy of products should be increased, for example, through new formulations, conjugation, or pegylation (d) drug delivery should be... 

Changes which may affect the quality and efficacy of product... 

The Antimicrobial I Panel did not provide a specific protocol for the assessment of the efficacy of products intended for this use but did suggest the incorporation of certain concepts in assessing product efficacy. The sampling procedures recommended are the cup scrubbing [25] or skin stripping techniques or any other appropriate techniques that allow accurate quantitation of the microbial flora at the test site. Any body site can be used but the genital area must be included. Clearly, the panel is concerned with notable differences of the microbial flora found in different parts of the human body. 

The optimal study design should be practical, yet provide accurate and reliable results based upon transient microorganism reductions, not resident ones. The healthcare personnel handwash is designed to evaluate the antimicrobial efficacy of products used in the healthcare field and, therefore, is excessively stringent for evaluating consumer product antimicrobial soaps. 

The HCPHWT was designed to assess the efficacy of products for use by healthcare workers, who wash their hands after frequently contacting potentially infected patients. The method is not ideal for assessing efficacy of consumer products because it does not encompass the myriad of sources of contamination in consumers or model their handwashing habits and frequency. 

The HCPHWT has been the traditional evaluation tool for antibacterial soap products in the United States. This is a controlled, clinical method with a historical database. Although it was intended to model in the healthcare setting, it has been used as the basis to support marketed claims for antibacterial soap products for both consumer and professional use. The above discussions demonstrate that the HCPHWT method does not provide control for many of the variables that can influence the performance of test products ( especially consumer products). Consequently, use of this test may not adequately evaluate the efficacy of products intended for use by consumers. A need exists for additional test methods specifically designed to evaluate consumer products while modeling real-world conditions. 

European Food Safety Authority, Opinion of the Scientific Panel on Additives and Products or Substances Used in Animal Feed on a request from the Commission on the safety and the efficacy of product Bio-Cox 120G as feed additive in accordance with Council Directive 70/524/EEC, EFSA Journal, 2004, 75, 1-51. 

Another concern of the responsible authorities, especially in the numerous countries where legislation forbids misleading advertising, is to verify the veracity of claims and the efficacy of products. Efficacy and claims may be linked to the presence of an ingredient in the finished product, whose presence and/or content must be verified, if necessary. 

Industry has standardized procedures for the quantitative sensory assessment of the perceived olfactory intensity of indoor malodors and their relationship to the deodorant efficacy of air freshener products. Synthetic malodors are used for these evaluation purposes. These malodors should be hedonicaHy associated to the "real" malodor, and must be readily available and of consistent odor quaUty. These malodors should be tested in various concentrations and be representative of intensities experienced under normal domestic conditions. 

In 1966 the PDA utilized the services of the National Academy of Sciences—National Research Council (NAS—NRC) to estabhsh the relative therapeutic efficacies of prescription dmgs marketed between 1938 and 1962. Those products that were found to meet safety and efficacy requirements were allowed to stay on the market. Suitable changes were required for other products for compliance, ie, formulation or label changes, additional data... 

Agricultural Products. Pesticides are frequendy appHed as emulsiftable concentrates. The active insecticide or herbicide is dissolved in a hydrocarbon solvent which also contains an emulsifier. Hydrocarbon solvent selection is critical for this appHcation. It can seriously impact the efficacy of the formulation. The solvent should have adequate solvency for the pesticide, promote good dispersion when diluted with water, and have a dash point high enough to minimise dammabiUty ha2ards. When used in herbicide formulas, low solvent phytotoxicity is important to avoid crop damage. Hydrocarbon solvents used in post-harvest appHcation require special testing to ensure that polycycHc aromatics are absent. 

Inlets for syringe sampling are divided kito two main categories one for packed-column and the other for capiHary-column devices. Eor packed columns, all material kijected is carried by the mobile phase onto the column. The inlet is usually an open tube, but sometimes, albeit rarely, the inlet itself may be packed, eg, to assure that the first centimeters of the column do not become contaminated with degradation products or nonvolatile materials that may affect the efficacy of the column. 

Claims for safety and efficacy of therapeutic dentifrices are regulated by the Pood and Dmg Administration. The Council on Dental Therapeutics of the American Dental Association reviews products and grants a Seal of Acceptance to those products deemed worthy. 

Although in many cases an enantiopure drug can be safer than the racemate, the advantages are clear. The final formulation of the drug product could be reduced inhalf, potential side effects could be minimized, and the resulting pharmokinetic and pharmacodynamic studies could clearly determine the efficacy of the active pharmaceutical ingredient (API) [21]. 

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