Identification study plans

Each study is given a unique identification and it is conducted in accordance with the study plan. The analyst that performs the tests has the responsibility to record the laboratory data promptly, accurately and legibly. Any changes in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the person making the change. 

A total of 31 of the 32 studies planned for the 21 compounds chosen for evaluation were completed. The results were reported by Storer et al. (2001). The overall spontaneous tumor incidence was low, 2.8 % for males and 6 % for females in studies without transponders (microchips for animal identification) and 8 % for males and 11.3 % for females in studies... 

But the question of the test item would not remain the only one. In such situations as described above the different studies would need different study plans, and would receive different study numbers and other means of identification as required by the GLP Principles ( A unique identification... 

First of all the physical location of the various study materials may be different, as has been described in the section on archive facilities (see page 180), and this has to be reflected in the archive s indexing and retrieval system. It has therefore to be ascertained that on looking up the identification tag of a specific study one would be led to the location of all the various documents and materials related to this study, and which have been identified as materials to be archived in the study plan and the final report. 

Model development is intimately linked to correctly assigning model parameters to avoid problems of identifiability and model misspecification [27-29], A full understanding of the objectives of the modeling exercise, combined with carefully planned study protocols, will limit errors in model identification. Compartmental models, as much as any other modeling technique, have been associated with overzealous interpretation of the model and parameters. 

Hazard and Operability Analysis (Hazop) (Kletz, 1992) is one of the most used safety analysis methods in the process industry. It is one of the simplest approaches to hazard identification. Hazop involves a vessel to vessel and a pipe to pipe review of a plant. For each vessel and pipe the possible disturbances and their potential consequences are identified. Hazop is based on guide words such as no, more, less, reverse, other than, which should be asked for every pipe and vessel (Table 1). The intention of the quide words is to stimulate the imagination, and the method relies very much on the expertise of the persons performing the analysis. The idea behind the questions is that any disturbance in a chemical plant can be described in terms of physical state variables. Hazop can be used in different stages of process design but in restricted mode. A complete Hazop study requires final process plannings with flow sheets and PID s. 

Also indices such as the Dow Fire and Explosion Hazard Index and the Mond Index have been suggested to measure the degree of inherent SHE of a process. Rushton et al. (1994) pointed out that these indices can be used for the assessment of existing plants or at the detailed design stages. They require detailed plant specifications such as the plot plan, equipment sizes, material inventories and flows. Checklists, interaction matrices, Hazop and other hazard identification tools are also usable for the evaluation, because all hazards must be identified and their potential consequences must be understood. E.g. Hazop can be used in different stages of process design but in restricted mode. A complete Hazop-study requires final process plans with flow sheets and PIDs. 

Upon identification of a new source for API, or in the event that the current API supplier makes any significant change to the approved synthetic process, revalidation should be considered. At a minimum, specificity of the method should be re-evaluated to ensure that any new process impurities and/or synthetic intermediates, precursors, etc. do not interfere with the analyte of interest. Revalidation is complete if the specificity study demonstrates that the change to the API has no adverse affect on the performance of the method. If the method is affected and changes are required, revalidation should proceed according to an original plan. 

Review of the quality of data, identification of data gaps, preparation of SIDS Dossiers including Robust Study Summaries and SIDS Testing Plans... 

The study is performed according to a plan approved (by dated signature) by the study director and verified for CLP compliance by the QA unit. Some countries also require formal approval by the test facility management and the sponsor. The plan should usually contain identification of the study, the test item and reference item, information concerning the sponsor and the test facility, dates, test methods, documents and materials to be retained, and other issues that have been identified. 

The results of this preliminary investigation (particularly the general behavior of the distribution coefficients and the Identification of multiple sorption mechanisms) will provide a basis from which plans can be developed for studying the sorption and complex chemistry of the actinides. The results will also provide a basis from which plans can be developed for studying sorption equilibria involving several competing nuclides. 

Early identification of unique or major human metabolites can provide clear directions for testing in animals, assist in interpreting and planning of clinical studies, and prevent delays in drug development/ approval. 

Sample custody, more formally referred to as Chain-of-Custody procedures, should be described in an SOP and reviewed. These procedures are necessary to ensure sample integrity and identification from collection through transport to the laboratory, to subsequent analysis and reporting. Various methods can be used from hand-written sheets on which logging-in and out, storage, and responsible personnel are indicated, to computerized bar code setups, to more stringent systems in which sealed vials are used. Whatever system is used, it should be adequate for the operation and specified either in an SOP or a study-specific protocol or work plan. 

The outputs of Step 1 illustrated for the case studies in a box on the next page include a list of the planning team members and their roles identification of decision makers a concise description and a conceptual model of the environmental problem in question and a summary of available resources and relevant deadlines for the project, such as the budget, personnel, and schedule. 

Development of study reference manual and monitoring plan Site identification selection, recruitment Prestudy site visits... 

Similarly, the use of a failure analysis approach for unexpected changes in final product or in process controls markedly help both the analysis and documentation requirements at each step. Finally, the use of a written and continually revised process development document is most helpful. The early identification of data requirements, special studies, and comparability decisions for use in process planning is important, especially with budget constraints. 

In planning the studies, they must reflect human exposure to the medicinal product and allow specific identification of stages at risk. Furthermore, the anticipated drug use especially in relation to reproduction, the physical nature of the test substance and route of administration or exposure should be taken into account. Also any existing data on toxicity, pharmaco-dynamics, kinetics, mechanisms of reproductive toxicity in humans or known from previously conducted studies, and similarity to other class-related compounds in structure and activity should be taken into consideration. 

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