Special population

Vaccines for special populations are Hsted in Table 2. Two vaccines that are in fairly widespread use in the adult population are vaccines that prevent viral influenza and pneumococcal pneumonia. 

Accepts information on the characteristics of populations located in areas that could be in the vulnerable zone Location of special populations (e.g., elderly-handicapped prisons and schools) and population density. 

Please describe planned study population. Choice of participants should be appropriate for the indication proposed. Subjects should not have enrolled in a clinical trial during the preceding 12 weeks. Please describe how special populations such as women of childbearing age, children and the elderly will be handled in this study. Please comment on the special need for close monitoring due to safety considerations. 

Some animal studies indicate that dietary exposure to methyl parathion causes decreased humoral and cellular responses (Shtenberg and Dzhunusova 1968 Street and Sharma 1975). A more recent, well-designed animal study that included a battery of immuno/lymphoreticular end points showed few effects at the nonneurotoxic doses tested (Crittenden et al. 1998). No adequate studies are available in humans to assess the immunotoxic potential of methyl parathion. Therefore, studies measuring specific immunologic parameters in occupationally exposed populations are needed to provide useful information. Further studies are also needed to investigate the mechanism for methyl parathion-induced immunotoxicity since this information would help to identify special populations at risk for such effects. 

Generally, arblockers are considered as second-line agents to be added on to most other agents when hypertension is not adequately controlled. They may have a specific role in the antihypertensive regimen for elderly males with prostatism however, their use is often curtailed by complaints of syncope, dizziness, or palpitations following the first dose and orthostatic hypotension with chronic use. The roles of doxazosin, terazosin, and prazosin in the management of patients with hypertension are limited due to the paucity of outcome data and the absence of a unique role for special populations or compelling indications from JNC 7. 

Special Populations and Patients with Concomitant Disorders... 

Recommend treatment approaches for special populations of patients with bipolar disorder, including pediatric patients, geriatric patients, and pregnant patients. 

Assessment and management by appropriate psychiatric specialists is important for special populations such as pediatrics, geriatrics, pregnancy, and others. 

Special populations at risk of high exposure to tetraethyl lead include workers at hazardous waste sites and those involved in the manufacture and dispensing of tetraethyl lead (Bress and Bidanset 1991). Recreational drug sniffers of leaded gasoline are also at risk (Edminster and Bayer 1985). 

ICH (1993) Harmonised Tripartite Guideline (E7). Studies in support of special populations Geriatrics. http //www.ich.org/LOB/media/MEDIA483.pdf. Cited 30 Dec 2008... 

Studies in support of special populations geriatrics Guidance on General Considerations for Clinical Trials Notice... 

Therapeutic use (Phase III/IV) Refine understanding of benefit/risk relationship in general or special populations and/or environment Identity less common adverse reactions Refine dosing recommendation Comparative effectiveness studies Studies of mortality/morbidity outcomes Studies of additional endpoints Large simple trials Pharmacoeconomic studies... 

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