Regulatory submissions

The basic elements and considerations for assay development, validation, and specification assignment are reviewed briefly. Assay development produces a method that requires validation for the analysis and release of materials (bulk or formulated finished product) for use in clinical development. The cumulative analysis of materials and stability considerations is then used to established specifications for internal and regulatory submission. 

Ultimately, the non-clinical data will form a substantial part of the regulatory submission that is required for marketing authorisation. 

A tablet containing two drug compounds, A and B, is being scaled up from kilogram to half-ton batches in preparation for a regulatory submission. The applicable specifications and sample work-up methods are... 

The amount and type of data required in the regulatory submissions depends on the quantity of substance supplied. The tonnage requirements are ... 

Technology providers use quantitative immunoassays to determine expression data of field material for regulatory submissions. Regulatory authorities require that expression levels of introduced proteins in various plant parts be determined by quantitative, validated methods. Immunoassays are also used to generate product characterization data, to assess food, feed and environmental characteristics, to calculate concentrations for toxicology studies and to obtain tolerance exemption or establish tolerances for pesticidal proteins. 

PCR is used to support regulatory submissions. For example, a petition for nonregu-lated stams for a biotech crop must contain the following information ... 

Does the application or system affect regulatory submission/registration ... 

You will be exporting, importing, and creating data for these models, so it is important that you learn about them. The FDA has begun to formally endorse the use of these data models in their guidance. Eventually the FDA will probably require data to be formatted to the CDISC model standards for regulatory submissions. 

Providing Regulatory Submissions in Electronic Format - General Considerations ... 

Computers. A certain number of personal computers are necessary for report generation and regulatory submission preparation. In addition, these may be useful for record keeping, depending on the type of stability information system that the company chooses to use. Alternatively, if the information system is intended to be accessible (read only) to many users, it may be more efficient to develop a local area network of mini-computers. The size of the database will help determine the nature of the software/hardware configuration used for this function. 

A Regulatory Apologia - a Review of Placebo-Controlled Studies in Regulatory Submissions of New-Generation Antidepressants , European Neuropsychopharmacology (2008)... 

This chapter will review some of the important methods for carrying out in vivo absorption and bioavailability studies, as well as attempt to provide an overview of how the information may be used in the drug discovery process. The chapter is aimed at medicinal chemists and thus will focus on the use of animals in discovery phase absorption, distribution, metabolism, and excretion/pharmacokinetic (ADME/PK) studies, rather than the design of studies that are for regulatory submission, or part of a development safety package. 

Phase Ilia. Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug Application (NDA) or other dossier. These clinical trials are conducted in patient populations for which the medicine is eventually intended. Phase Ilia clinical trials generate additional data... 

Phase Illb. Clinical trials conducted after regulatory submission of an NDA or other dossier, but prior to the medicine s approval and launch. These trials may supplement earher trials, complete earlier trials, or may be directed toward new types of trials (e.g., quality of life, marketing) or Phase IV evaluations. This is the period between submission and approval of a regulatory dossier for marketing authorization. 

Food and Drug Administration. Guidance for Industry, Providing Regulatory Submissions In Electronic Format—General, FDA, Rockville, MD, 1999. 

Method validation is the process of proving that an analytical method is acceptable for its intended purpose. Many organizations provide a framework for performing such validations (ASTM, 2004). In general, methods for product specifications and regulatory submission must include studies on specificity, linearity, accuracy, precision, range, detection limit, and quantitation limit. 

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