Method submission

VALIDATION OF FOOD CHEMICALS CODEX METHODS Submissions to the Food Chemicals Codex... 

This next method was included with a submission by Ritter that appeared in the Theoretical section of this book. 

This reference system is considered to be more useful than the conventional superscript number method since it enables the reader to see immediately in which year and in which journal (at least for the more common journals whose letter codes soon become familiar) the work cited was published. The reader is thus able to go directly to the original literature reference without having to consult a bibliography. It also provides the author and editor with the considerable advantage of being able to add or delete references up to the final submission of the manuscript without altering the numbering system. 

Recklinghausen, K. 1978. Method and Devise for Protecting Ethylene Oxide Producing and Processing Plants Against the Decomposition of Ethylene Oxide. German Patent Submission No. P28.50254.7 (November 20, 1978). 

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. 

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... 

After the submission of this contribution, a remarkable review authored by Ratnasamy, Srinivas and Knozinger has appeared on the investigation, by means of both experimental and theoretical methods, of the active sites and reactive intermediates in titanium silicate molecular sieves [126]. 

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. 

An agrochemical company provided four submission formats to PMRA the CADDY specification, the PDF format, the PDF viewed in a Web browser, and paper. PMRA reviewers compared these formats in a methodical and unbiased manner. PMRA determined that the PDF format gave evaluators a 23% gain in efficiency over paper. They felt that the results clearly demonstrated that the PDF format provided evaluators with sufficient desktop functionality and improved efficiency. 

Prepare a mechanical design of the chlorobenzene column, estimating the shell thickness, the positions and sizes of all nozzles, and the method of support for the plates and the column shell. Make a dimensioned sketch suitable for submission to a drawing office. 

There is one additional general requirement included in Directive 75/318/EEC as amended, which affects all parts of the pharmaceutical section of the dossier. This is a blanket requirement that all analytical methods are to have been adequately validated and the validation data included in the submission. This applies to all analytical methods including those used in connection with preclinical and clinical parts of the dossier. Additional guidance on how to meet these requirements is included in the two notes for guidance developed on the topic of analytical validation through the ICH process, available at the EMEA web site or at the Commission s web site, mentioned earlier. 

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. 

This section explains the benefits of online and traditional paper applications. You will learn the potential pitfalls of each, and how to avoid them, as well as tips to ensure your application looks its best, no matter which submission method you choose. 

More colleges and universities are offering the option of applying over the Internet. It has fast become the submission method of choice for many schools but, it is not necessarily for everyone. 

During phase III the analytical laboratory performs systematic methods validation and continues with product characterization. A suitable formulation or a formulation candidate is in place and testing for stability continues. Production evaluates the consistency of the manufacturing process, which should be at a scale capable of delivering commercial quantities. Advanced studies are continued or initiated to evaluate chronic toxicology and reproductive side effects in animal models. Parallel to phase III studies, preparations are made for the submission of the BLA. 

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. 

Ocean Data Evaluation System (ODES) Data Submissions Manual QA/QC Guidance for Sampling and Analysis of Sediments Water and Tissue for Dredged Material Evaluations Chemical Evaluations Quality Assurance Plan for the National Pesticide Survey of Drinking Water Wells Analytical Method 2, Chlorinated Pesticides Quality Assurance Project Plan for Analytical Control and Assessment Activities in the National Study of Chemical Residues in Lake Fish Tissue... 

Reproducibility is the third and final portion of precision testing. Here, samples are prepared and compared between testing sites. This usually occurs at the time of technology transfer. Samples are prepared in a similar manner between the two sites and are compared to a previously agreed-upon set of acceptance criteria. As per the ICH, reproducibility studies are not a part of submission filings, but should be performed as a confirmation of the ability of each testing site to perform the method reliably. An executed reproducibility study can be used in place of intermediate precision for the validation of a method, although there is no problem if both validation parameters are evaluated. 

---