eswar lal
☆    

Hyderabad,
2006-10-27 14:55
(6362 d 15:57 ago)

Posting: # 329
Views: 4,830
 

 opening of a new ba/be unit [Regulatives / Guidelines]

Dear
Iwant to know, minimum requirements to open a new Bioavailablity and Bioequivalence facility for IND, ANDA submissions in India
Please guide me in this regard
Helmut
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Vienna, Austria,
2006-10-28 18:30
(6361 d 12:22 ago)

@ eswar lal
Posting: # 330
Views: 4,224
 

 opening of a new ba/be unit

Dear Eswar,

as a first starting point I would recommend the recently published "Fortieth Report (WHO Technical Report Series No. 937)", which gives some guidelines for CROs in it's Annex 9 (Additional guidance for organizations performing in vivo bioequivalence studies).
You may download the entire document here: 1.9MB PDF.

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eswar lal
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Hyderabad,
2006-10-30 06:07
(6359 d 23:45 ago)

@ Helmut
Posting: # 331
Views: 4,066
 

 opening of a new ba/be unit

Dear Sir
thanks for ur prompt reply. I found the guideline very useful and informative.
Please let me know if there is any specific Indian guideline related to opening of BA/BE unit.
Helmut
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Vienna, Austria,
2006-10-30 12:10
(6359 d 17:42 ago)

@ eswar lal
Posting: # 336
Views: 4,152
 

 opening of a new ba/be unit

Dear Eswar,

have a look at paragraph 6 of the respective CDSCO-Guideline.

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