Regulatory guidelines development

Once the determinative or confirmatory method has been developed to take full advantage of the chemical properties of the analyte molecule, a study is necessary to prove that the method is valid. Criteria for method validation are outlined in guidelines from the US FDA, US EPA, and EU. A summary of the differences in regulatory requirements for method validation is provided in Table 3. The parameters addressed by all of the regulatory guidelines include accuracy, precision, sensitivity, specificity, and practicability. 

A number of alternative sizing methods are available, and these are described in Table 8. The American Association of Pharmaceutical Scientists, Inhalation Focus Group conducted a comprehensive review of available methods, which was published in a series of articles identified in the last column of the table. All of the methods described either have been or are currently employed in the development of aerosol products. However, at this time only the inertial samplers, cascade impactors and impingers appear in compendial standards and in regulatory guidelines [44-46], Other methods such as thermal imaging are also under development and may give complementary size information to the current methods. 

Worlds apart are the practices, yet the official policies and regulatory guidelines in developing countries show much influence from those of the developed world. While waste import bans are common in the developing world, the topography of recycling and disposal costs seems to assure a flow of e-waste out of the developed world down to the points of lowest-cost disposal. 

There are no regulatory guidelines or suggested test methods for evaluating agents for muscular or vascular irritation. Since such guidelines are lacking, but the evaluation is necessary, those responsible for these evaluations have tried to develop and employ the most scientifically valid procedures. 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

After one or more lead compounds have been selected for further development, more preclinical investigations are needed before it is possible to start studies in humans. The main studies during this phase are toxicity studies in animals. It is important to note that the goal of these studies is not so much to find safe compounds and rejecf unsafe ones, but rather to learn under which conditions a potentially beneficial compound can be harmful, and to find out how it can be used safely in humans, if at all. Details on the type, duration and extent of toxicity studies needed can be found in various regulatory guidelines issued by ICH, FDA and EMEA and are easily accessible via the internet sites of these bodies. Although there are still differences in the requirements... 

The regulatory guidelines adopted for nonclinical safety assessment during drug development are primarily those of the ICH (1). The Indian regulatory system accepts any animal toxicity data generated in other countries as well. 

Today, extensive regulatory guidelines shape the way new medicines or chemicals are developed but we remain heavily reliant on the ability of the rodent, dog, rabbit, and monkey to predict the outcome of human exposure. Many potentially useful drugs are rejected due to the adverse effects (often at high doses) outweighing the potential benefit but adverse events continue to be detected in marketed drugs. 

Sparrow, P.A., Irwin, J.A., Dale, PL, Twyman, R.M., and Ma, J.K. (2007). Pharma-Planta road testing the developing regulatory guidelines for plant-made pharmaceuticals. Transgenic Res. 16(2) 147-161. 

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