Special population studies

Bioanalytical chemistry support and pharmacokinetic and special population studies conducted. 

The answer, of course, lies in the fact that many clinical trials are less than ideal candidates for publication. These poor publication candidates may be trials that did not result in a positive outcome, or those that generated data about some prosaic aspect of drug action (e.g. tolerability in a special population). Studies replicating a positive finding are often a regulatory requirement, but me-too papers do not find homes in prominent journals. Lastly, some good studies are less than ideal publication candidates solely because the manuscript has been drafted badly. 

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. 

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... 

Studies in Support of Special Populations Geriatrics General Considerations of Clinical Trials Statistical Principles for Clinical Trials... 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E7 Note for Guidance on Studies to Support of Special Populations Geriatrics,... 

Special populations Use a starting dose of 6 mg/25 mg for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine/fluoxetine (eg, female gender, elderly, nonsmoking status). When indicated, perform dose escalation with caution in these patients. Olanzapine/fluoxetine has not been systemically studied in patients older than 65 years of age or in patients younger than 18 years of age. 

The SNA research going on throughout the world at about the time of the Edgewood studies Is relevant to this study. The experiments at Edgewood were not unusual and did not Involve extraordinary doses (see Table 3-1) or special populations of volunteers, compared with experiments In the laboratories and clinics of scientists and clinical researchers throughout the world. 

UNODC estimates based on local studies, special population group studies, and /or law enforcement agency assessments. 

Hasford, J. and Lamprecht, T., Company observational post-marketing studies drug risk assessment and drug research in special populations — a study-based analysis, Eur. J. Clin. Pharmacol, 53, 369, 1998. 

Drug efficacy and response is a function of drug concentration over time. In clinical pharmacokinetic studies, aspects of drug absorption, distribution, metabolism, and excretion over time are assessed. In the early clinical development the pharmacokinetics of a drug is studied in healthy subjects followed by studies in patient population(s) with the aim to find the relevant dose in the target population(s). Particular pharmacokinetic studies in special populations assess the necessity of a dose adjustment from the planned/established clinical dose for patients. 

ICH-E7 (August 1994) Guideline for Industry Studies in support of special populations Geriatrics US FDA (1978) General considerations for the clinical evaluation of drugs. December 1978... 

This type of hADME study will always have an explorative character, and typically comprises less than the normal minimum of 12 subjects for a PK study. If the compound is expected to show different and unpredictable ADME characteristics in special populations, then it might be necessary to include these populations in addition to normal, healthy subjects. Or, if other conditions might influence ADME in an unpredictable manner (e.g. food effects), then it might even be necessary to run the study in a cross-over design. The inclusion of females (being not of childbearing potential) was discussed several times, but it seems to be a rare exception for hADME studies. 

E7 Studies in support of Special Populations Geriatrics CPMP/ICH/379/95 Step 5... 

Clinical pharmacokinetics to support phase 1 studies and to design and conduct pharmacokinetic studies in special populations... 

Perform pharmacokinetic studies in special populations (geriatric... 

---