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Objective 4 — Effectiveness

Objective 4 is to confirm drug effectiveness in large-scale clinical trials. The results of these trials are summarized in the Integrated Summary of Efficacy (ISE) portion of the NDA/BLA submission and play an important role in determining appropriate therapeutic indications, dose regimens, and benefit/risk ratios for various patient populations. [Pg.506]


Effects noted in study and corresponding doses Mild subjective neurological effects (eye and throat irritation, headache, fatigue, drowsiness) were reported at 200 ppm (LOAEL). No objective effects, as measured by dexterity and coordination tests, were seen. However, 50% of the subjects reported that the neurobehavioral tests required greater mental effort for them to perform. [Pg.304]

Many factors influence how a policy is implemented and whether it achieves its objectives effectively. Experience in policy implementation in many areas indicate the importance of good organization. A number of organizational attributes, such as a sound structure, efficient procedures, well-trained personnel and adequate financial resources, are considered cmcial for effective policy execution (18, 19, 20, 21). [Pg.38]

Objective Effect of ultrasound on simple one step organic syntheses. [Pg.385]

Object Effect of ultrasound on various fractions of distilled crude oil. [Pg.389]

Object Effect of ultrasound on the photocatalytic decomposition of KI using Ti02 doped with Eu, Gd, Ce, Dy. [Pg.390]

Objective effects. Journal of the American Medical Association, 30, 542-557. [Pg.283]

Antipsychotic drugs with strong sedative clinical effects (e.g. chlorpromazine. clozapine, olanzapine) produce subjective and objective sedation and impair most areas of performance in healthy volunteers, usually at doses far below those typically used in patients. Antipsychotic drugs with little sedative clinical action (e.g. pimozide, sulpiride, amisulpride) produce few subjective and objective effects in healthy... [Pg.89]

Cooper, L. A., Schacter, D. L., Ballesteros, S., and Moore, C. (1992). Priming and recognition of transformed three-dimensional objects effects of size and reflection. Journal of Experimental Psychology Learning, Memory, and Cognition, 18, 43-57. [Pg.311]

In a double-blind study in 12 healthy volunteers, psilocybin 115 and 250 micrograms/kg significantly impaired their ability to reproduce interval durations longer than 2.5 seconds and to synchronize to inter-beat intervals longer than 2 seconds it also caused them to be slower in their preferred tapping rate (10). These objective effects on timing performance were accompanied by... [Pg.627]

Fractional distillation, absorption, and stripping are the most common separation unit operations. All these services can use packing to achieve their mass-transfer objectives. Effective hydraulic and mass-transfer... [Pg.747]

If the region of interest in the sample is not well defined, it is advantageous to acquire more than one slice through the object. Effective use of instrument time is achieved by... [Pg.213]

An important part of implementing procedures is training the persoimel on the procedures. The objective of this training is to ensure that people know how to safely perform their job. The more closely the training reflects actual job performance, the more likely you are to achieve that objective. Effective procedures provide a clear definition of safe job performance. Therefore, procedures can be used to train personnel and to evaluate their ability to perform the job safely. [Pg.30]

In order to pursue this latter objective effectively, at least two practical actions can be envisaged ... [Pg.179]

HSE observation card is a method that is to encourage employees voluntarily observed the operating persormel behavior. Its purpose is to encourage safety behavior, stop and correct unsafe behavior. Through the effective communication, it can be to strengthen operation persormel to safety consciousness and standardize safety behavior. At the same time, it will see that the work environment and facilities and the use of tools, and found that and deal with imsafe condition of object, effectively avoid and reduce accident and the occurrence of injury. [Pg.318]

Aim to ascribe to a grid. Screens operate and look better when their components are aligned and serve a utilitarian objective effectively. Grid-based screens are usually easier to implement in computer code because of visual elements predictability. Two guidelines with respect to ascribing to a grid are as follows ... [Pg.157]

When developing the objectives for the safety performance program established, the data needs should be identified. Data concerns that should addressed early involve determining if the data needed for the performance measures exist and if so, is the data reliable and readily available. Also, in order to measure a safety performance objective effectively, more than one measure maybe needed. It is best to use avariety of measures to ascertain performance rather than just one. Multiple measures provide a better picture of the true status of the safety performance. [Pg.96]

Schoedel KA, Meier D, Chakraborty B, Manniche PM, Sellers EM. Subjective and objective effects of the novel triple reuptake inhibitor tesofensine in recreational stimulant users. Clin Pharmacol Ther 2010 88(1) 69-78. [Pg.17]

A set of risk maps, included partially in the Kuril Islands Atlas (Atlas..., 2009) was compiled. In addition, the table of the wei t of contribution of zonal and local factors into the formation of tsunami parameters for 17 bays was made and the photo archive that contains photos from the 50s of the 20th century was collected. It includes photographs of natural objects, effects of tsunami waves and other dangerous processes on the coast of the Khabarovsk Krai and Primoiye. [Pg.534]

Ultimately, OSHA does require hazard abatement so that each consultation visit achieves its objective-effective employee protection. If you fail to eliminate or control identified serious hazards (or an imminent danger) according to the plan and within the limits agreed upon or an agreed-upon extension, the situation must be referred from consultation to an OSHA enforcement office for appropriate action. This type of referral is extremely rare. [Pg.194]

In February, 1990 WSRC conducted a survey on the effectiveness of the Employee Concerns Program. An Action Plan to address program deficiencies was issued March 30, 1990 (Reference 19). . The plan addresses three objectives effective advertising, policy and procedure review, and development of performance indicators. Implementation of the plan is nearly complete. Closing tasks include issuance of a revi,sion to MRP 1.06 and the evaluation of performance Indicators, including an employee survey. [Pg.42]


See other pages where Objective 4 — Effectiveness is mentioned: [Pg.506]    [Pg.109]    [Pg.89]    [Pg.91]    [Pg.77]    [Pg.193]    [Pg.251]    [Pg.28]    [Pg.550]    [Pg.620]    [Pg.536]    [Pg.158]    [Pg.764]    [Pg.232]    [Pg.165]    [Pg.141]    [Pg.522]    [Pg.457]    [Pg.49]    [Pg.49]    [Pg.629]    [Pg.48]    [Pg.133]    [Pg.443]    [Pg.21]    [Pg.21]    [Pg.23]    [Pg.24]    [Pg.51]    [Pg.22]   


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