Bioequivalence and Bioavailability Forum

rajmohan ● 2009-03-31 10:45 (5885 d 23:22 ago) Posting: # 3421 Views: 6,003	Data Management SOPs for BA /BE [GxP / QC / QA] Post reply
	Hi all, I would like to know the Data Management SOPs that are mandatory for BA/BE set-up with more focus on Pharmacokinetics. Any insights/suggestions for the above greatly appreciated. Please let me now if am posted on the right category or not. Thanks & Regards, RAJ

MGR ★ India, 2009-04-01 10:31 (5884 d 23:37 ago) @ rajmohan Posting: # 3431 Views: 4,844	Data Management SOPs for BA /BE Post reply
	Dear Raj, I think that in BA/BE studies the data management part is very less when compared to Clinical trials field. I think so, in this BA/BE field data management SOP's are like Handling of Bioanalytical data to the PK department Backup and archival of the PK and Statistical data May be this helps. Thank you, — Regards, MGR

rajmohan
●

2009-04-02 10:24
(5883 d 23:44 ago)

(edited on 2009-04-02 11:49)
@ MGR
Posting: # 3451
Views: 4,818

Data Management SOPs for BA /BE

Post reply

Dear MGR,

Thanks for your reply. It is true that the data analysis activity in BA/BE is constrained. Acutally I forget to mention about the requirement of statistical SOPs for BA/BE in the last post. To my knowledge, have planned to implement the following SOPs in place as given below and please let me know other Statistical SOPs need to be incorporated for efficient statistical practice.

Randomization Schedule
Sample size, power calculation including kinetic sampling points
Handling of analytical data and verification
Outlier detection and handling
Crossover & Parallel Design statistical analysis

Many thanks.

Best Regards,
RAJ

Edit: Full quote removed. Please see this post! [Jaime]

Data Management SOPs for BA /BE [GxP / QC / QA]

Data Management SOPs for BA /BE

Data Management SOPs for BA /BE