Stability failure

Failure to follow stability protocol or to include stability failures with the filing... 

Unsatisfactory Data If the stability data under the ICH conditions fall outside the acceptance criteria while data from the parallel study under the previously approved conditions or 25°C/ambient humidity, whichever applies, are satisfactory during the previously approved expiration dating period, and the added humidity is determined to be the cause for the stability failure, the product will still be considered to be in compliance with the regulatory specifications approved in the application. If the applicant decides to adopt the ICH conditions, a Changes Being Effected Supplement with a shortened expiration dating period or a Prior Approval Supplement with revised product specifications may be submitted where justified. Other measures (e.g., more protective container and closure or product reformulation) may be considered through a Prior Approval Supplement. 

Failure is conditioned to the effective stress state, according to equation (3). Figure 12, which compares the safety factor (defined by the ratio F/o i) after excavation, shows the necessity to consider full THM couplings when studying the rock mass stability ( Failure corresponds to a safety factor lower than 1, in dark blue on Figure 12). 

We now proceed to the combined effects of coupled folding and binding reactions. The effect of linked reactions cannot be overstated in the analysis of thermodynamic data. Simple examples of the effect of linkage include the stabilization of a protein by metal ion binding, or the effect of pH on thermal stability. Failure to account for these reactions can lead to unknown (or unintended) contributions to the thermodynamic parameters. The purpose of linkage analysis is to separate the individual contributions to obtain the thermodynamic parameters associated with the intrinsic reaction of interest. Such an analysis is particularly valuable for interpretation of thermodynamic parameters in terms of structure. 

Keywords methane gas hydrate, centrifugal experiments, stratum stability, failure process... 

The formation of coagulum can often be correlated with (i) conversion (ii) agitation rate (iii) mode of addition of ingredients. Generally, the amount of coagulum formed increases with increasing conversion, but this observation may be the result of an initial stability failure which becomes more obvious as the polymerization proceeds. Since latexes can be flocculated by mechani-... 

Exposure of the material to temperature, solar radiation, water, wind, environmental pollution, and stabilizer failure, in addition to roof traffic, poor workmanship, and lack of maintenance will induce either physical or chemical changes or both that affect the properties of the membrane. Therefore, proper evaluation of the membrane is required to determine the type of change. 

In the pre-development stage, core samples can be used to test the compatibility of injection fluids with the formation, to predict borehole stability under various drilling conditions and to establish the probability of formation failure and sand production. 

The use of selectively reduced integration to obtain accurate non-trivial solutions for incompressible flow problems by the continuous penalty method is not robust and failure may occur. An alternative method called the discrete penalty technique was therefore developed. In this technique separate discretizations for the equation of motion and the penalty relationship (3.6) are first obtained and then the pressure in the equation of motion is substituted using these discretized forms. Finite elements used in conjunction with the discrete penalty scheme must provide appropriate interpolation orders for velocity and pressure to satisfy the BB condition. This is in contrast to the continuous penalty method in which the satisfaction of the stability condition is achieved indirectly through... 

The best-known equation of the type mentioned is, of course, Hammett s equation. It correlates, with considerable precision, rate and equilibrium constants for a large number of reactions occurring in the side chains of m- and p-substituted aromatic compounds, but fails badly for electrophilic substitution into the aromatic ring (except at wi-positions) and for certain reactions in side chains in which there is considerable mesomeric interaction between the side chain and the ring during the course of reaction. This failure arises because Hammett s original model reaction (the ionization of substituted benzoic acids) does not take account of the direct resonance interactions between a substituent and the site of reaction. This sort of interaction in the electrophilic substitutions of anisole is depicted in the following resonance structures, which show the transition state to be stabilized by direct resonance with the substituent ... 

Dielectric Strength. Dielectric failure may be thermal or dismptive. In thermal breakdown, appHed voltage heats the sample and thus lowers its electrical resistance. The lower resistance causes still greater heating and a vicious circle, leading to dielectric failure, occurs. However, if appHed voltage is below a critical value, a stabilized condition may exist where heat iaput rate equals heat loss rate. In dismptive dielectric failure, the sample temperature does not iacrease. This type of failure is usually associated with voids and defects ia the materials. 

Addition to cis- and /n t-2-butene theiefoie yields different optical isomers (10,11). The failure of chlorine to attack isobutylene is attributed to the high degree of steric hindrance to approach by the anion. The reaction intermediate stabilizes itself by the loss of a proton, resulting in a very rapid reaction even at ambient temperature (12). 

Bevantolol hydrochloride is a moderately lipophilic, long-acting, cardioselective -adrenoceptor blocker. It has no ISA but has membrane-stabilizing activity. The dmg is in use in Europe for the treatment of hypertension and angina. It is rapidly absorbed from the GI tract. Peak plasma levels occur in 1—2 h. It is metabolized extensively in the Hver to a metaboHte that has some ISA. It is excreted by the Hver and the kidneys and excretion is delayed in patients having kidney failure. 

Power system stability studies can provide some insight into the effects of power failure. The calculations can become tedious if performed manually because of the iterative steps required to obtain satisfactory answers. Therefore, a computer program is used to supply the iterative answers in a short time and with comparable accuracy. 

With DLE eombustors, the aim is to burn most of the fuel very lean to avoid the high eombustion temperature zones that produee NOx. So these lean zones that are prone to oseillatory burning are now present from idle to 100% power. Resonanee ean oeeur (usually) within the eombustor. The pressure amplitude at any given resonant frequeney ean rapidly build up and eause failure of the eombustor. The modes of oseillation ean be axial, radial or eireumferential, or all three at the same time. The use of dynamie pressure transdueer in the eombustor seetion, espeeially in the low NOx eombustors ensures that eaeh eombustor ean is burning evenly. This is aehieved by eontrolling the flow in eaeh eombustor ean till the speetrums obtained from eaeh eombustor ean mateh. This teehnique has been used and found to be very effeetive and ensures eombustor stability. 

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