Ethnic factors

E4 Dose-Response Information to Support Drug Registration Ethnic Factors... 

E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data Good Clinical Practice E6(R1) Good Clinical Practice... 

Psoriasis is a common inflammatory skin disorder which is estimated to affect 1.5% to 3% of the Caucasian population.1,2 It may present at any age.3,4 Ethnic factors influence disease prevalence. In the United States, prevalence among blacks (0.45% to 0.7%) is lower than in the remainder of the United States population (1.4% to 4.6%).1 Between 10% and 30% of patients with psoriasis will also have psoriatic arthritis.5 In 10% to 15% of psoriatic patients with arthritis, joint symptoms actually appear prior to skin involvement.3 Clinical depression is another frequent comorbid illness in these patients. A recent United States survey showed that 8% to 10% of psoriatic patients aged 18 to 54 years old actively contemplated suicide because of their psoriasis.6... 

Lawson, W. B. (1986). Racial and ethnic factors in psychiatric research. Hosp. Comm. Psychiatry, 37, 50M. 

Lawson, W. B. (1990). Biological markers in neuropsychiatric disorders racial and ethnic factors. In E. Sorel, ed., Family, Culture, and Psychobiology. New York Levas. 

Foreign clinical results are acceptable except in areas where there are immunological and ethnic differences between Japanese and foreigners. The ethnic factors are divided into two components intrinsic factors such as racial factors and physiological differences and extrinsic factors, which include cultural and environmental issues. In these cases, the MHLW may require that some bridging comparative clinical trials be performed with dose ranging protocols. This will enable absorption, distribution, metabolism, and excretion studies to be carried out on Japanese individuals and provide better dosage and indication for the Japanese people. The MHLW also requires that application be accompanied by one year of real-time stability data and that sterility test results be included. 

Efficacy Nine topic headings—Clinical Safety, Clinical Study Reports, Dose-Response Studies, Ethnic Factors, GCP, Clinical Trials, Clinical Evaluation by Therapeutic Category, Clinical Evaluation, Pharmacogenomics total of 18 guidelines... 

Foreign data are acceptable to Japan s authority but there may be additional information with regard to immunological responses and ethnic factors required to gain approval (Section 7.4). 

Japan has adopted the ICH GCP guidelines for clinical trials since 1997. It upholds the Helsinki Declaration to ensure the rights, welfare, and privacy of subjects are protected in clinical trials. Japan accepts foreign clinical trials, but bridiging trials may need to be performed to take into consideration effects of ethnic factors. 

The influence of ethnic factors on drug responses in clinical trials is important in two contexts. First, the regulatory application should contain data that is generated from subjects whose ethnic mix is in proportion to that in the population where the medicinal product will be used. Second, an applicant may wish that data generated in one country with one ethnic predominance should be used to gain marketing approval in another country where the ethnicity of the population is different. 

Implementation Working Group (IWG) set up to develop recommendations and clarifications for the E5 Guideline on ethnic factors in acceptability of foreign clinical data. 

The marketing/distiibuting rules in Japan have become almost identical to those in the West, and GCP is updated in-line with the International Conference on Harmonisation (ICH) GCP. ICH discussion on ethnic factors established a concept that foreign clinical data are accepted for new drug application if there are no concerns... 

Huang S-M, Temple R Is this the drug or dose for you Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice. Clin Pharmacol Ther 2008 84 287 or http //www.fda.gov/cder/genomics/publications.htm... 

It is estimated that RLS affects up to 10% of the population in North America and Europe. In Japan, India, and Singapore, the rates of incidence are much lower, suggesting that ethnic factors may play a role in the disorder. RLS also tends to run in families, suggesting a genetic basis. RLS affects males and females alike, and the symptoms seem to get worse as the person grows older. Pregnancy and hormonal changes also make the symptoms of RLS worse. The severity of the symptoms can rise and fall over time and may even occasionally temporarily disappear. 

EU CPMP (1999) Note for Guidance on Modified Release Oral and Transdermal Dosage Forms Section II (Pharmacokinetic and Clinical Evaluation) July 1999 EU CPMP (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence. July 2001 ICH-E5 (1998) Ethnic Factors in the Acceptability of Foreign Clinical Data. March 1998... 

Although bone marrow aplasia has not been related with certainty to either the daily or the total dose of chloramphenicol or to the sex or age of the patients, it has occurred almost exclusively in individuals who were taking prolonged therapy, particularly if they were exposed to the drug on more than one occasion (24). The condition is rare, occurring about once in every 18 000-50 000 subjects in various countries. These variations may in part depend on ethnic factors (25,26). For example, there have been very few cases reported in blacks (27). Bone marrow aplasia due to chloramphenicol has usually resulted in aplastic anemia with pancytopenia other forms, such as red cell hypoplasia, selective leukopenia, or thrombocytopenia, are less common. 

Guidelines on the ethnic factors in the acceptability of foreign clinical data and handling of foreign cliniccil data introduced. 

In accordance with the agreement of ICH E-5, the Notification No. 672 on the ethnic factors in the acceptability of foreign clinical data and No. 739 on the handling of foreign clinical data of the PAB in August 1998 were prescribed. Consequently, the Notification No. 660 was eliminated. The new Notifications No. 672 and 739 stipulate that foreign clinical data meeting the requirements can be accepted as attached data and scientifically necessary Japanese clinical data are... 

The contents of the guidelines on ethnic factors in the acceptability of foreign clinical data are same as the ICH guidelines (E-5). The major points of the question and answer and understandings of the guidelines are indicated in the Notification No. 672. 

Buckalew LW, Coffield K Drug expectations associated with perceptual characteristics ethnic factors. Percept Mot Skills 55 915-918,1982 Budd RJ, Hughes IC, Smith JA Health beliefs and compliance with antipsychotic medication. Br J Clin Psychol 35(3) 393-397,1996 Carbajal D, Casaco A, Arruzazabala L Pharmacological screening of plant decoctions commonly used in Cuban folk medicine. J Ethno-pharmacol 33 21-24,1991... 

Lawson WB Racial and ethnic factors in psychiatric research. Hospital and Community Psychiatry 37 50-54,1986a Lawson WB The black family and chronic mental illness. American Journal of Social Psychiatry 6 57-61,1986b Lawson WB Clinical issues in the pharmacotherapy of African-Americans. Psychopharmacol Bull 32 275-281,1996 Lawson WB Psychiatric diagnosis of African Americans, in Cross Cultural Psychiatry. Edited by Herrera JM, Lawson WB, Sramek JJ. New York, Wiley, 1999, pp 99-104... 

Other ethnic factors with pharmacologic implications... 

For further discussion, see sections on Evolution of ICH Topics and Ethnic Factors and Clinical Responsiveness (Papaluca, Amanti, 1993). 

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