Author Topic: ANY ONE HAS ANY QUERY ABOUT BA/BE STUDIES FEEL FREE T ASK ME,IM IN BA/BE STUDIES  (Read 25297 times)

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Offline ravitelkar

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Dear Dr. Kumar Gaurav                                                         




please could you tell me the checklist and requirements for biogenerics products to conduct clinical phases in india... please its urgent























































Thank you
Ravi

Offline ravitelkar

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Dear Dr. Kumar gaurav,
                                                           
Could you please let me know the check list, required documents, Application process to submit DCGI or DGFT for import of plasma samples to India.
                                                                 
Regards
RAVI

Offline csdhar

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i,M RESERACH SCIENTIST IN MNC INVOLVED IN CONDUCTING BA/BE STUDIES.PLZ FEEL FREE TO DISCUSS

Dear Dr Gaurav,
 I am interested in conduction BA/BE studies for a novel herbal drug formulation - the active herbal drug is already sold widely as a Nutraceutical and has GRAS accredit ion: given that I am new to this area, can you outline the process for undertaking such studies:

1. Costs
2. Timeline to complete 5-10 healthy voluteer BA/BE studies
3. Recommended CRO contacts in India capable of undertaking such studies.

thanks!
S Dhar

Offline gangahulsure

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What is the maximum quantity of blood can be withdrawn from subject ? any gidelines.

Offline Dr.Gunasakaran

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Dear Mr.Gangahulsure,

From healthy adults and non-pregnant women who weigh normal for their age and not more than 500 ml blood is drawn in an 8 week period and frequency of collection is not more than 2 times per week;

ii. from other adults and children, where the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected has been considered and not more than 50 ml or 3 ml per kg, whichever is lesser is drawn in an 8 week period and not more than 2 times per week;

iii.from neonates depending on the haemodynamics, body weight of the baby and other purposes not more than 10% of blood is drawn within 48 – 72 hours. If more than this amount is to be drawn it becomes a risky condition requiring infusion/blood transfusion

Reference: Indian Council of Medical Research (ICMR) Revised Ethical guidelines for Biomedical Research on Human Participant, Page 22
http://icmr.nic.in/ethical_guidelines.pdf

Regards,
Dr.S.Gunasakaran, MD
Head-Clinical Research & Medical Affairs, Azidus Laboratories Ltd, CRO
Disclaimer: All the responses and the postings in this Forum are my personal views and opinion. It does not represent/reflect my company strategies and polices on the same.

Offline gangahulsure

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Offline gangahulsure

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Dear Dr Ravi,
























































   
One more query . If we have one SR formualtion which is given BID .(200 mg tablet BID - innovator ) . But in domestic market it is available as 100mg tablet IR which is given after 4-6 hrs. We can not  import Innovator so need to  use 100mg IR product as refernce product. So shall we design 200mg SR BID Vs 100 mg QID . Is multidose possible? (we do not want to go for steady state)




Offline Dr.Gunasakaran

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Dear Mr.Gangahulsure,

Could your please tell us for which country's Submission you are planning to submit this BE study for answering your query?

Regards,
Dr.S.Gunasakaran, MD
Head-Clinical Research & Medical Affairs, Azidus Laboratories Ltd, CRO
Disclaimer: All the responses and the postings in this Forum are my personal views and opinion. It does not represent/reflect my company strategies and polices on the same.

Offline srinivaskotagiri

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We are looking for certificated GCP training, please provide the details. Our team size is 40 members and we will spend the 2-3 days for training session.

Please mail me the details to srinivasarao.kotagiri@anacipher.com