Information to be included

The amount of information shown on a flow-sheet will depend on the custom and practice of the particular design office. The list given below has therefore been divided into essential items and optional items. The essential items must always be shown, the optional items add to the usefulness of the flow-sheet but are not always included. 

Nominal operating pressure (the required operating pressure). 

Physical property data, mean values for the stream, such as  

Stream name, a brief, one or two-word, description of the nature of the stream, for example ACETONE COLUMN BOTTOMS . 

The stream physical properties are best estimated by the process engineer responsible for the flow-sheet. If they are then shown on the flow-sheet, they are available for use by the specialist design groups responsible for the subsequent detailed design. It is best that each group use the same estimates, rather than each decide its own values. 

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The Board of Editors welcomes both the submission of preparations for future volumes and suggestions for change that will enhance the usefulness of Organic Syntheses. Submitters are kindly asked to examine the instructions appearing before the Preface in this volume that describe the type of preparations we wish to receive and also the information to be included in each contribution A Style Guide for preparing manuscripts is available from the Secretary to the Board, and submitters are requested to follow its instructions. 

It is important to note that OSHA specifics the information to be included on an MSDS, but docs not prescribe the precise format for an MSDS. A non-mandatory MSDS form that meets the Hazard Communication StancLird requirements has been issued and can be used as is or c.xpandcd as needed. The MSDS must be in English and must include at least Oie following information presented in Table 10.5.1, In reviewing this material, Uie reader should understand tlic effect and importance of each subsection in helping to identify a chemical hazard, particularly tlie section on healtli hazards. 

The following summarizes the information to be included when educating the parents of a child receiving a vaccination. 

Figure 10.2 Information to be included in a clinical investigation statement.

Where a laboratory is working to a particular quality standard, there may be particular requirements governing the level of information to be included in a report to a customer. In cases where such a level of information might confuse the customer, it is normally possible, with the agreement of the customer and the body overseeing the quality standard, to obtain dispensation to provide a simplified report, provided that the omitted information is available and can be reported if required. 

Another continuing project on aqueous nonelectrolytes is the International Data Series B. The editor is Dr. J. A. Larkin of the National Physical Laboratory in England. It is published in the form of supplements of loose-leaf sheets and issued at irregular intervals of a few months. Each sheet is prepared and submitted by an author or authors. The data are presented in a standard format and must follow certain rules with regard to kind of properties, style, units, and kind of auxiliary information to be included. Standard table formats have been designed for each kind of property included. Each table is reviewed by an editor specially selected from an international panel. 

There is a reordering of the information to be included in the SPC. With regard to generic medicines, the final paragraph of Article ii states that for authorisations under Article 10, those... 

Under Directive 2004/27/EC, there are various changes to the information to be included on the product label and certain provisions relating to the product s package leaflet. There is also a new requirement for the name of the medicinal product to be expressed in Braille format on the label. For products containing up to three active substances, the legislation specifies that the international non-proprietary name (INN) must also appear on the labelling. The MAH must also ensure that the package leaflet is made... 

What process do you use for gathering the information to be included for my resume (an in-person interview, telephone interview, written questionnaire, e-mail questionnaire, etc.) ... 

The following section provides an example of the general content of a requirements specification deliverable and the type of information to be included. 

The required information to be included in the application is found under 21 CFR 316.20(b), shown as (9) items. Number the items in your application 1 though 9 and respond to the nine items as described. Creative numbering is not helpful. 

Before a detailed discussion of the information to be included in this section is given, it is useful to review the definition of adequate and well-controlled studies. Approval of a new drug requires substantial evidence of effectiveness. Substantial evidence is defined under the Federal Food, Drug and Cosmetic Act as... 

In this section, an overview of the results should show that the regulatory requirements for approval have been met by adequate and well-controlled studies that support the claimed effect. This is especially important if results are inconsistent or marginal. An examination of study-to-study differences in results, effects in subsets of the treated population, dose-response information, and comparisons with alternative drugs should be addressed. A description of the information to be included in this section is contained in the outline provided earlier in this chapter. 

Bayesian analysis provides another alternative (also computationally intensive) to deal with very weak signals and avoid FT artifacts. This method, which uses probability theory to estimate the value of spectral parameters, permits prior information to be included in the analysis, such as the number of spectral lines when known or existence of regular spacings from line splittings due to spin coupling. Commercial software is available for Bayesian analysis, and the technique is useful in certain circumstances. 

The rules relating to the evaluation of ein MA application, to the information to be included in the summary of the product characteristics and to the technical regulations governing analytical, pharmaco-toxicological and clinical trials shall be set out in a Rule from the Minister of Health. 

Figure 11-6 Key information to be included in the nonclinical toxicology summary for an 1ND application to support the first in human clinical plan.

Although information about dietary supplements is widely available on the Internet, it is usually provided by product distributors, and is designed to sell products rather than to provide objective information about product efficacy and toxicity. Even reviews of dietary supplements in journals, newsletters, books, and electronic databases can be biased or incorrect. In compiling information to be included in Herbal Products Toxicology and Clinical Pharmacology, Second Edition, emphasis was placed on the use of original studies published in reputable, peer-reviewed journals. Older studies, as well as more current literature, were utilized for completeness, with an emphasis on newer literature and double-blind, controlled trials. Where appropriate, information was obtained... 

The protocol is the written document that describes the studies to be conducted. The information contained in the protocol will be used to complete the stability report at the end of the study. The information to be included in the protocol is... 

INDIVIDUAL SUBJECT REPORT FORMS. A PMA or PMA supplement, if applicable, is required by 21 CFR 814.20(b)(6)(ii) to include copies of individual case report forms for each subject who died during a clinical investigation or who did not complete the investigation. Before submitting the PMA, the applicant should consult with the Office of Device Evaluation (ODE) reviewing division to determine the information to be included in these report forms, how many copies are required, and whether these forms will be required for other subjects enrolled in the study (e.g., subjects experiencing specified adverse effects or complications). 

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