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drmuneesh ★ 2009-02-05 13:48 (6347 d 14:19 ago) Posting: # 3183 Views: 6,381 |
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Dear All I have some queries in bioequivalence studies of hormone replacement therapy preparations in postmenopausal females: 1. In most of the published literature the inclusion Criteria considered are: female subjects who are in good health within 45-65 years of age and are in postmenopausal phase (i.e. history of permanent cessation of menstruation at least for the last one year) with -estradiol levels <20 pg/ml and FSH > 40 IU/ml. But it is difficulty to get volunteers with -estradiol levels <20 pg/ml and FSH > 40 IU/ml. Normal range of -estradiol for postmenopausal females is 10.0-44.0 ng/ml and of FSH levels is 17.0-95.0 mIU/ml. Then what levels should we consider for -estradiol and FSH in studies of postmenopausal females. 2. What should be the range for BMI as it is difficult to get BMI between 18 and 25 in that age group. 3. Usually subjects with normal blood pressure (systolic blood pressure > 100 or < 140 mm of Hg or diastolic blood pressure > 60 or < 90 mm of Hg) are included but in this elderly age group many females will be having hypertention and will be taking medicines for the same. What should be the upper limit of blood pressure and should we allow them to continue taking their antihypertensive drugs as we donot include volunteers taking any medications in bioequivalence studies to avoid any intractions. 4. What about subjects having diabetes and taking medicines for the same. Please suggest. Thank you Regards Dr Muneesh Garg -- Edit: Category changed. Please don't use UTF-8 coded characters (see the 'Instructions for Use'). Please edit your post within the next 24 hours to change the character '' (since it's in the 'private area' of UTF, I'm not sure which symbol you wanted to display - 'beta'?). [Helmut] |
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JPL ☆ Vienna, 2009-02-05 16:12 (6347 d 11:55 ago) @ drmuneesh Posting: # 3184 Views: 5,227 |
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Dear Muneesh, ❝ Normal range of -estradiol for postmenopausal ❝ females is 10.0-44.0 ng/ml and of FSH levels is 17.0-95.0 mIU/ml. Then ❝ what levels should we consider for -estradiol and FSH in studies ❝ of postmenopausal females. Are these normal ranges the published ones for that age? Notice, that normal ranges depend on the laboratory, which is analyzing the samples. ❝ 2. What should be the range for BMI as it is difficult to get BMI between ❝ 18 and 25 in that age group. It dpends on the influence of the BMI on the endpoint. @3: Again; it depends on your endpoint. If the concomitant mediccation is suggested to have a high impact, these patients are excluded often. If the impact is low, they may continue intake all over the study to have the same bias with all measurements. Alternatively the intake may be stopped (depending on the medication), but this has to be done as long before the study starts as possible. ❝ 4. What about subjects having diabetes and taking medicines for the same. The same as to point 3. Regards, JPL |
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drmuneesh ★ 2009-02-06 06:28 (6346 d 21:40 ago) @ JPL Posting: # 3187 Views: 5,382 |
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Dear JPL, 1. Normal range of estradiol for postmenopausal females is 10.0-44.0 ng/ml and of FSH levels is 17.0-95.0 mIU/ml which is given by the laboratory which analyzing the samples. But some published studies include females with estradiol levels <20 pg/ml and FSH >40 IU/ml. So please suggest what to do. 2. BMI range of 18 and 25 is usually followed in adults to see their health status. But in the age group of 45-65, females with BMI range of 18 and 25 is very difficult to get. And there is no published literature showing influence of the BMI on the endpoint. So please suggest what to do. 3. For point 3 and 4, this is ok that if the concomitant medication is reported to have interaction with the study drug, then the intake of concomitant medication may be stopped. And if the concomitant medication is not reported to have interaction with the study drug, they may continue intake all over the study to have the same bias with all measurements. Thank you Regards, Dr Muneesh Garg -- Edit: Again, please don't use UTF-characters! Use the Preview -button to check your post. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2009-02-06 13:28 (6346 d 14:39 ago) @ drmuneesh Posting: # 3189 Views: 5,207 |
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Dear Muneesh, ❝ 2. BMI range of 18 and 25 is usually followed in adults to see their ❝ health status. But in the age group of 45-65, females with BMI range of 18 ❝ and 25 is very difficult to get. And there is no published literature showing ❝ influence of the BMI on the endpoint. So please suggest what to do. You are right; according to WHO ( Technical Report Series 854, Chapter 7, 317-318 (1995)): 'Age and Sex. In many affluent countries the prevalence of grades 1 and 2 overweight in men increases with age up to about 55 years, then levels off before finally decreasing somewhat in old age. In women, prevalence continues to rise until old age and then levels off. [...] In postmenopausal woman, and to a lesser degree in men, BMI increases with age even when body weight remains stable, because of age-associated decline in stature. Although age-specific BMI is usually lower in premenopausal than in men, the overall prevalence of overweight is generally higher in women.' If it's a cross-over study, why don't you set your upper limit of the BMI to e.g., 29? P.S.: Don't use UTF in you posts (the forum's XHTML Code Page is ISO-8859-1). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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drmuneesh ★ 2009-02-07 07:12 (6345 d 20:55 ago) @ Helmut Posting: # 3195 Views: 5,122 |
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Dear HS Thank you for the reply but to set your upper limit of the BMI to e.g., 29, Ethics Committee is asking for reference of any published study where this upper limit of BMI has been considered or any guidelines allowing the same. Regards Dr Muneesh Garg |
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Helmut ★★★ Vienna, Austria, 2009-02-07 12:58 (6345 d 15:09 ago) @ drmuneesh Posting: # 3199 Views: 5,156 |
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Dear Muneesh! ❝ [...] set your upper limit of the BMI to e.g., 29, Ethics Committee is ❝ asking for reference of any published study where this upper limit of ❝ BMI has been considered or any guidelines allowing the same.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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drmuneesh ★ 2009-02-09 05:54 (6343 d 22:14 ago) @ Helmut Posting: # 3210 Views: 5,086 |
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Dear HS Thanks very much for the reply and explaining the impact of BMI in BE studies Regards Muneesh |
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Ohlbe ★★★ France, 2009-02-08 00:42 (6345 d 03:25 ago) @ drmuneesh Posting: # 3204 Views: 5,173 |
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Dear drmuneesh, ❝ ... then the intake of concomitant medication may be stopped. In the case of antihypertension or antidiabetic drugs I would consider as totally unethical to ask the subjects to stop their treatment for several weeks to participate in a BE trial. Your Ethics Committee should pay attention to these aspects rather than to stupid BMI limits. Regards Ohlbe |
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drmuneesh ★ 2009-02-09 05:50 (6343 d 22:17 ago) @ Ohlbe Posting: # 3209 Views: 5,064 |
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Dear Ohlbe Thanks very much regards Muneesh |
Ing. Helmut Schütz