Vishal S
☆    

India,
2021-06-22 07:25
(86 d 14:01 ago)

Posting: # 22424
Views: 634
 

 Ethnicity of Indian population [Regulatives / Guidelines]

Hiii

What is the Ethnicity of Indian population, for Bioequivalence study subjects. Kindly provide information for same.


Regards
Vishal S
drgunasakaran1
★★  
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2021-06-24 06:06
(84 d 15:20 ago)

@ Vishal S
Posting: # 22429
Views: 448
 

 Ethnicity of Indian population

Dear Mr Vishal,

» What is the Ethnicity of Indian population, for Bioequivalence study subjects. Kindly provide information for same.

Bioequivalence study subjects are usually categorized into two groups,

1. Hispanic-Latino
2. Not Hispanic-Latino

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

Indian population will be categorized as Not Hispanic-Latino.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
VijithRoy
☆    

India,
2021-06-30 06:43
(78 d 14:43 ago)

@ drgunasakaran1
Posting: # 22440
Views: 394
 

 Ethnicity of Indian population

Dear Dr S Gunasakaran,

» Bioequivalence study subjects are usually categorized into two groups,
»
» 1. Hispanic-Latino
» 2. Not Hispanic-Latino

Based on what basis this two groups has been categorized?

With Best Regards,
Vroy.
Achievwin
★    

US,
2021-07-06 16:21
(72 d 05:05 ago)

@ Vishal S
Posting: # 22461
Views: 320
 

 Ethnicity of Indian population

» What is the Ethnicity of Indian population, for Bioequivalence study subjects.

In the demographics tables for FDA we are required to provide Race and Ethnicity in two different categories.

For Race: It is Asian (to be precise Asiatic Indians)
For Ethnicity: is Non-Hispanic non Latino or simply others (danger: you may have others 100% for studies using Indian BE studies)

Hope this helps,
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