Indicators action

ISO 10012 requires that the integrity of measuring equipment be confirmed at appropriate intervals established on the basis of stability, purpose, and usage. With new equipment it is customary to set the frequency at 12-month intervals unless recommended otherwise by the manufacturer. Often this frequency remains despite evidence during calibration that accuracy and precision is no longer stable. Such action indicates that the calibration staff have not been properly trained or that cost rather than quality... 

Distortion Another problem with extrusions is caused by distortion of the section by the effect of heat and other environmental conditions such as exposure to water or chemical agents that tend to soften the plastic. These distortions are generally reversals of the profile back to the shape that it had exiting in the die. This action indicates that the post die forming operations were done at a lower than desirable temperature which results in a molded-in stress. When the stress is relieved the product distorts. In some instances these stresses cannot be eliminated by process changes so that the product is inherently deficient in performance. 

The overall outline of action indicated in the 100-Day Report is encouraging. The Agency seems ready to proceed with the implementation of TSCA in an orderly manner focused only on those particular... 

Fig. 19 The lack of any systematic change in either systolic or diastolic blood pressure throughout the duration of EA 3443 action indicates clearly that its effects are primarily central.

WDI includes molecular structures and 2-D coordinates for most entries. Thirteen kinds of names are distinguished such as Trade Name, USANs and CAS numbers. There are seven types of pharmacological data pharmacological activity, mechanism of action, indications and usage, precautions and warnings, contraindications, adverse effects and interaction data. Two kinds of enzymes appear in the database the enzymes... 

Dihydroindolone derivatives do not structurally belong to any of the classes of drugs examined above. Flowever, their mechanism of action, indications of use, and side effects are very similar to phenothiazine derivatives. 

The lead investigator is responsible for the preparation of the EIR. Other members of the inspection team may be called upon to participate in its preparation, however, particularly in supplying specialized scientific or technical information. The field investigator and the supervisor at the district office will tentatively classify the completed EIR under one of the following three categories No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). 

The category NAI signifies no action indicated. This means that the laboratory is essentially in comphance with the GLP regulations. Ordinarily the inspected facihty receives no further correspondence from the agency concerning the inspection, and reinspection is scheduled on a routine basis. 

Prior to December 1993, the classifications VAI-1, VAI-2, and VAI-3 were used to characterize the GLP comphance of an inspected facility. The category VAI means voluntary action indicated. The numerals 1, 2, and 3 formerly indicated degrees of failure to comply with the GLP regulations VAI-1 meant that the violations were minor and may have been corrected before the inspections was concluded, and VAI-2 indicated that minor procedural deficiencies were found that did not threaten to compromise the validity of any studies done under those circumstances. Those GLP inspections that were formerly classified VAI-1 and 2 are now termed VAI. 

It is a very potent sulfonylurea with long duration of action indicated in non-insulin dependent (type II) diabetes, whenever blood sugar levels can not be controlled adequately by diet, physical exercise or reduction in body weight. 

Information on cell and population kinetics of cancer cells explains, in part, the limited effectiveness of most available anticancer drugs. A schematic summary of cell cycle kinetics is presented in Figure 54-2. This information is relevant to the mode of action, indications, and scheduling of cell cycle-specific (CCS) and cell cycle-nonspecific (CCNS) drugs. Agents falling into these two major classes are summarized in Table 54-1. 

Acyclovir, valacyclovir, penciclovir, and famciclovir are synthetic guanine analogs with inhibitory activity against members of the herpesvirus family, including herpes simplex types 1 and 2. Their mechanism of action, indications, and usage in the treatment of cutaneous infections are discussed in Chapter 49. 

In addition to providing a form FDA-483, FDA investigators prepare an establishment inspection report (EIR), which is sent to FDA headquarters, which then evaluates the report and determines the corrective action, if any. The FDA then classifies the inspection as no action indicated, voluntary action indicated, or official action indicated. The EIR contains much greater detail than contained in the 483 and is not provided to the manufacturer until after the inspection is deemed closed. 

At the conclusion of each inspection, FDA investigators prepare a report summarizing any deficiencies. In cases where they observe numerous or serious deviations, such as falsification of data, DSI classifies the inspection as official action indicated and sends a warning letter or Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) to the clinical investigator, specifying the deviations that were found. 

ODER conducts about 300-400 clinical investigator inspections annually. About 3 percent are classified in this official action indicated category. 

Cumene has a potent narcotic action characterized by a slow induction period. It is a depressant to the central nervous system. The long duration of its action indicates a possible slow rate of elimination, meaning that cumulative effects must be considered. Cumene is thought to have a greater acute toxicity than either benz or toluene (Ref 4) Cumene is used in org synthesis as a solvent, diluent, and as an additive to aviation gasoline... 

Scopolamine [skoe POL a meen], another belladonna alkaloid, produces peripheral effects similar to those of atropine. However, scopolamine has greater action on the CNS and a longer duration of action in comparison to those of atropine. It has some special actions indicated below. 

Product (Approval Date) Mechanism of Action Indication Toxicity Test Species... 

The FDA Web site contains a list of the testing facilities that have been inspected since October 1,1989 [39], The list provides the current name and former (if known) names of the testing facility, the dates the facility has been inspected, and the classification of the inspection results. Active toxicology laboratories, university laboratories, foreign laboratories, and inactive laboratories are listed. The list is updated quarterly. The most common outcome of inspections include NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated). For inspections with an OAI classification, regulatory and administrative actions will be recommended. Warning letters may or may not be issued with an OAI classification. 

A sentence is said to be in active voice when the subject of the sentence is the doer of the action indicated by the verb. The subject of an active verb is doing the action of the verb. In passive voice, the subject is the receiver of the action indicated by the verb. 

The appropriate clinical program is influenced by many factors, including the degree of molecular complexity of the particular protein and the extent of physicochemical characterization the mode of action, indication(s), and use population(s) the presence of established structure-activity relationships and validated bioassays and the results of preclinical testing. 

Ratings action indicator or probability indicator Overall rating... 

Qualitative rules are used for determining an overall rating for extent of regulatory action and an overall rating for the probability associated with that extent of action being necessary. The qualitative ratings for the three action indicators or the indicators for the associated probabilities are separately combined using the rules exemplified in Table 5.8. 

E Low action indicator High probability indicator Medium action High probability High action High probability... 

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