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When the individual feels at the mercy of an apparently all powerful captor discount 25mg fildena otc erectile dysfunction 2015, it may well be as important to him to be able to demonstrate to himself that he can control his respiration or can make a limb heavy as the actual ability to decrease physical pain fildena 100mg discount erectile dysfunction diabetes reversible. Biderman (11) has discussed the importance to the interrogation subject of maintaining the feeling of control through either real or illusory devices buy fildena with a visa erectile dysfunction smoking. As long as the individual is able to induce subjective changes at will he may maintain a feeling of control which cannot be taken away levitra super active 40 mg visa. Anecdotal evidence obtained in personal communication from an individual subject to extensive interrogation by the Gestapo may illustrate the point purchase generic viagra plus pills. This subject found that he was able to control the point of passing out during interrogation order cheap viagra professional line. Whether in fact he had control of this kind or whether he had the illusion of control is unimportant because the subjective feeling helped to maintain his mastery of the situation throughout several months of intensive interrogation. It is possible that autogenous -204- training may be a technique for providing the potential captive with an untouchable and effective technique of mastery in a situation where he is physically totally at the mercy of his captors. Prevention of subsequent trance induction, by a posthypnotic suggestion to that effect, seems unlikely. The posthypnotic induction of amnesia and anesthesia for the event of capture would leave the captive in a more vulnerable position than he would have been otherwise, if indeed it is feasible at all. The training in hypnosis necessary to achieve these phenomena might well make the subject more accessible to attempts at trance induction by an enemy interrogator. Information about what the soldier might expect under conditions of captivity, about the techniques of enemy interrogation, about the kind of reactions he might experience in himself would all be desirable in terms of increasing his ego control and therefore his mastery of a potentially difficult situation. Two specific techniques designed to enhance ego control were suggested: the use of motivating instructions and the technique of autogenous training. Defense Against the Use of the Hypnotic Situation in Interrogation The technical reasons for the limited utility of hypnosis as an instrument of interrogation have been discussed here at some length. It is highly questionable whether it is possible to induce a trance in a resistant subject. Furthermore, even if trance could be induced, considerable evidence indicates that it is doubtful whether a subject could be made to reveal information which he wished to safeguard. And finally, it has been shown that the accuracy of such information, were any to be obtained, would not be guaranteed since subjects in hypnosis are fully capable of lying. However, it is possible that both -205- hypnosis and drugs, such as pentothal, scopolamine, sodium amytal, etc. It would be well to differentiate between the effectiveness of hypnosis as such and the hypnotic situation. The latter seems to offer greater potential applicability for interrogation purposes. The psychological meaning of the situation to the captive during interrogation is one which varies widely from individual to individual. It is not our purpose here to review the meaning of capture and 1 interrogation from a psychodynamic viewpoint, but only to consider briefly why individuals will undergo extremes of physical and mental suffering to prevent the interrogator from obtaining the desired information.

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Whether materials No Yes like gunny bags or -- -- wooden pallets are allowed in manufacturing areas 100mg fildena with mastercard erectile dysfunction japan. How contamination -- with metals Metal detector Metal detector No metal prevented buy fildena us impotence at 17. How heating of Melting facility Melting facility No -- base like in dedicated in dedication dedicated petroleum jelly is done in the area with 5 area together facility discount fildena 50mg online impotence diabetes. Pls specify whether Prospective Concurrent Retrospecti the critical ve No processes validatio validated n Prospectively viagra plus 400 mg fast delivery, retrospectively or concurrently 75mg sildenafil sale. Whether validation -- Yes No of following -- performed and documented: Analytical methods discount 100 mg kamagra amex, Production and assay equipment, Sterile production processes, Non- sterile production processes, Cleaning procedures, Critical support systems (purified water, water for injections, air, vapor, etc. Please list reasons -- Reason and No considered justification justification -- important for for each step listed validation or re- listed validation. In case electronic -- Yes No data processing -- systems are used, are these validated? Please specify whether periodical challenge tests performed on the system to verify reliability. Are the validation -- Yes No studies performed -- according to pre- defined protocols? Is the validity of the critical processes and procedures established based on a validation study? Are criteria -- Yes No established to -- assess the changes originating a revalidation? Are trend analyses performed to assess the need to re-validate in order to assure the processes and procedures continue to obtain the desired results? Whether its report includes Conclusion / Summary, description of the performed assay, Data tables, Results, Conclusions, Protocol reference, Revision and approval signatures. In the case of water for injections systems, are the daily sampling records of at least one usage point available, with all the usage points sampled weekly? Whether report -- Yes No contains Summary, -- Description of performed tests/assays, Obtained data tables, Results, Conclusions, Installation diagrams, Revision and approval signatures. Whether report contains Summary, Description of performed tests/assays, Obtained data tables, Results, Conclusions, Revision and approval signatures. Does the protocol -- Yes No define the selection -- criteria for products or groups of products subject to cleaning validation? Is data produced -- Yes No supporting the -- conclusion that residues were removed to an acceptable level? Whether validation -- Yes No 1 records include -- Recovery study data, Analytical methods including Detection Limits and Quantification Limits, Acceptance Criteria, Signatures of the Quality Assurance Manager, employee in charge of cleaning and the verification from Production and Quality Control. Name of product (v) Generic Name (vi) Brand Name (vii) Dosage Form (viii) Strength 2.

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Sampling Time For this reason generic fildena 50mg on-line impotence lipitor, at least as many containers should be sam- pled as the number of sampling times in the stability study buy fildena 25mg overnight delivery best erectile dysfunction pills 2012. The sample time points should be chosen so that any For products packaged in containers intended for dis- degradation can be adequately profiled (i generic fildena 25mg on line erectile dysfunction causes psychological. The sampling protocol should be submitted Stability testing for long-term studies generally should in the drug application buy discount forzest 20 mg line. If the individual units example discount zithromax amex, certain radiopharmaceuticals generic 40 mg levitra extra dosage, the intervals entered the container randomly, then samples may be taken between sampling times should be shortened. However, testing for accelerated studies generally should be per- because dosage units near the caps of large containers may formed at a minimum of four time points, including the have different stability properties than do dosage units in initial sampling time. For dosage units sampled of scheduling analysis is not an acceptable practice in this fashion, the location within the container from because it may cause delay in finding and responding to which the samples were taken should be documented and out-of-specification test results or may adversely affect the this information included with the test results. Unless the product is being tested for homogeneity, The degradation curve is estimated most precisely, in composites may be assayed, rather than individual units. If composites are used, increased number of replicates at the later sampling Stability Testing of Drug Substances and Drug Products 43 times—particularly the latest sampling time—is encour- 2. Expiration Dating Period aged because this will increase the average sampling time for an Individual Batch toward the desired expiration dating period. Annual Stability Batches within specifications depends not only on the rate of phys- ical, chemical, or microbiological changes but also on the After the expiration dating period has been verified with initial average value for the batch. Thus, information on three production batches, a testing program for an the initial value for the batch is relevant to the determina- approved drug product should be implemented to confirm tion of the allowable expiration dating period and should ongoing stability. For every approved application, at least be included in the stability study report. Percentage of one batch of every strength in every approved container label claim, not percentage of initial average value, is the and closure system, such as bottles or blisters, should be variable of interest. If the manufacturing interval is greater than 1 year, is based on the observed pattern of change in the quan- the next batch of drug product released should be added titative attributes (e. Bracketing and matrixing can be under study and the precision by which change is used to optimize testing efficiency. The recommendations in this section do not apply to An acceptable approach for analyzing an attribute that compressed medical gases, blood, or blood products. Data Analysis and Interpretation mated curve intersects the acceptable lower specification limit. Where the estimated curve is assumed to be linear for Long-term Studies based on 24 months of real-time data and the lower spec- A stability protocol should describe not only how the ification limit is assumed to be 90% of label claim, an stability study is to be designed and carried out but also expiration dating period of 24 months could be granted. When analyzing an attribute that is expected to increase This section describes an acceptable statistical approach with time, the 95% one-sided upper confidence limit for to the analysis of stability data and the specific features the mean is recommended. In When analyzing an attribute with both an upper and general, an expiration dating or retest period should be a lower specification limit, special cases may lead to appli- determined on the basis of statistical analysis of observed cation of a two-sided 95% confidence limit. Limited extrapolation of the real-time data although chemical degradation of the active ingredient in beyond the observed range to extend the expiration dating a solution product would cause a decrease in the assayed or retest period at approval time may be considered if it concentration, evaporation of the solvent in the product is supported by the statistical analysis of real-time data, (through the container and closure) would result in an satisfactory accelerated data, and other nonprimary stabil- increase in the concentration.

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