Planning study

V. Shorrocks, Ese of Copperas a Micronutrient for Crops, Parti, Planning Study, INCRA, New York, July 1984. 

To start a detailed planning study, space requirements must be known for various products, by-products, and r iw materials, as well as for process equipment. A starting or reference point, together with a directional schematic flow pattern, will enable the design engineers to make a trial plot plan, as e.xplained below, A number of such studies will be required before a suitable plot and elevation plan can be chosen. 

Generation data to complement the planning study were plentiful. As long as the utilities owned the physical facilities and were in control of future facility expansion, data were generally a nonissue. The parameters of generating plants were dialed into the calculations or computers, similar to transmission. Obviously, alternate locations for new plants could be evaluated, and oftentimes studies were finalized some ten years ahead of construction, with only limited analysis required as the in-seivicc date approached. 

Please describe planned study population. Choice of participants should be appropriate for the indication proposed. Subjects should not have enrolled in a clinical trial during the preceding 12 weeks. Please describe how special populations such as women of childbearing age, children and the elderly will be handled in this study. Please comment on the special need for close monitoring due to safety considerations. 

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. 

The sample temperature is increased in a linear fashion, while the property in question is evaluated on a continuous basis. These methods are used to characterize compound purity, polymorphism, solvation, degradation, and excipient compatibility [41], Thermal analysis methods are normally used to monitor endothermic processes (melting, boiling, sublimation, vaporization, desolvation, solid-solid phase transitions, and chemical degradation) as well as exothermic processes (crystallization and oxidative decomposition). Thermal methods can be extremely useful in preformulation studies, since the carefully planned studies can be used to indicate the existence of possible drug-excipient interactions in a prototype formulation [7]. 

Impressive Paul had always been both observant and analytic. He was easier to work with than were some of the other psychologists. They were more into experimental than clinical psychology and were often skeptical about some of my quickly planned studies. Lengthy discussions about experimental design usually turned into futile arguments. 

The first consideration, as always, will be safety information that can be obtained more safely in healthy subjects, which may subsequently reduce risk to patients, should prompt a debate on whether it is wise to progress according to plan or whether an additional study should be performed in healthy subjects. Another option that may be considered is to proceed with the planned study in patients but to admit them to hospital or a clinical investigation unit for all or part of the dosing period. However, this might not be feasible because suitable facilities and staff are not available or because the anticipated rate of patient recruitment might be considered unacceptably slow. 

The medical statistician s role in regard to the investigation should be that of obstetrician, rather than morbid anatomist, for it is unfair to expect him to extract scientific knowledge by performing a kind of mathematical post mortem upon the numerical remains of a badly planned study. [Green FHK, Principle Medical Officer, Medical Research Council, The Lancet, 1954 ii 1084-1091.]... 

The government had required that the sponsors should have their own in-house study review board to review the ethical aspects of clinical trial protocols. Such a requirement was based on the former Japanese GCP, which stipulates that the company should organise an internal formal body or mechanism that reviews and authorises its planned studies before submitting to either study centres or the MHW for clinical trial plan notification. 

The new Japanese GCP no longer contains a clause to this effect, but it seems that the authorities favours the sponsor to maintain the procedures for an in-house study review board and to determine the appropriateness of the planned studies. 

There has been quite a large stream of research concerned with capacity expansions and retrofit problems in the chemical and operations research literature. In this section, however, we will concentrate on expansion and strategic multisite planning studies. Single site short-term and mid-term planning and scheduling studies are beyond the scope of this book and the interested reader is referred to the work by Bodington and Baker (1990), Pinto, Joly and Moro (2000), and Kallrath (2005). 

Before selecting one of the different mous and rat strains available from commercial supphers for a given experiment, one has to carefully consider the rationale of the planned study (Andrews 1996 Crawley et al. 1997 Owen et al. 

A protocol is a written set of instructions broader in scope than a SOP. SOPs are the detailed written instructions for procedures routinely performed in the course of any of the activities associated with pharmaceutical manufacturing. A protocol describes the details of a comprehensive planned study to investigate the consistent operation of new system/equipment, a new procedure, or the acceptability of a new process before it is implemented. 

Abstract This article deals with a planning study of electrical power supply in Georgia... 

Contract IAEA TC-ARM/0/004 Energy and Nuclear Power Planning Study for Armenia (covering the period 1999-2020) . Signed in 1998, IAEA, Vienna, Austria. 

A protocol for each planned study should be provided—phase 1 protocols may be less detailed than phase 2 and 3 protocols. 

Safety analyses are not typically prespecified in the study protocol and/or the study analysis plan. Studies are typically powered on efficacy outcomes (the primary objective in therapeutic confirmatory trials see Chapter 9), and the sample size that results from this sample-size estimation may be considerably smaller than would be needed for a thorough investigation of safety data. 

Production planning studies the amounts of the various products which should be manufactured in a given plant when the production requirements are known. This problem must be considered during the plant design stage. Scheduling decides in which equipment each product should be manufactured, when the operation starts, and when it is expected to finish. 

PANELIST PASSMAN Not really in terms of the various kinds of supplemental fuels. Low and medium could be considered almost together. We are really looking for the industry to say what their applications are and state their willingness to do studies because they intend, when the conditions are right, to put in a plant. We hope to get a variety of responses from industries such as chemical feedstock, different regions, types of coal, and provide some measure of support for this feasibility and planning study. We want to do that as soon as possible. 

Congress first allocated monies to fund a planning study for an Environmental Health Sciences Center in 1961. 

It is said that a well-formulated question contains half the answer. By the same token, a well-planned study is the key to the success of the study. The following list of planning stages is suggested and is given as a summary of the present chapter ... 

Be particularly aware that the abandonment of a planned study may be especially wise if the protocol did not include a placebo control. There is an assumption implicit in studies of active agent versus active agent, which is that... 

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