Bioequivalence and Bioavailability Forum • Population BE for in-vitro data

Population BE for in-vitro data [Regulatives / Guidelines]

posted by Ankita – India, 2011-06-24 17:32 (5481 d 10:06 ago) – Posting: # 7170
Views: 7,324

Hi All,

Can anybody help me in to calculate 95% upper bound with population BE for in-vitro data. I have used the SAS code given in the link http://www.pqri.org/commworking/minutes/pdfs/dptc/psdpcwg/Addl/DC01-526048-v1-PBE_Description_for_PQRI_Prof_Comp.pdf and based on the reference http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070118.pdf

Please help me to clarify the calculation of a2, a3, a4, a5 and V which is used to calculate H₀ in the below SAS code.

a2 = 0.0313 - (13.624/f_T) - (10.182/f_R) - (29.155/(f_T*f_R)) + (25.121/(f_T*f_R)) - (5.623/(f_R*f_R));

a3 = -0.0306 + (10.236/f_T) + (13.495/f_R) - ( 9.822/(f_T*f_R)) - (12.207/(f_T*f_R)) + (32.396/(f_R*f_R));

a4 = 0.0243 - ( 8.113/f_T) - ( 4.703/f_R) - (12.564/(f_T*f_R)) + (14.810/(f_T*f_R)) + (3.528/(f_R*f_R));

a5 = ((a1 + a2 + a3)/t) - 1 - a4;

V = (a1 + (a2*C) + (a3*C*C))/(1 + (a4*C) + (a5*C*C));

UCL = del + (V*sqrt(M));

LCL = del - (V*sqrt(M));

E0 = del*del;

H0 = max(LCL*LCL, UCL*UCL);

Regards

Ankita

Complete thread:

Population BE for in-vitro dataAnkita 2011-06-24 15:32
- Critical value d_labes 2011-06-29 09:07
  - Critical value Ankita 2011-06-30 19:06
- Population BE for in-vitro data krishna 2013-06-18 14:01
  - Population BE for in-vitro data krishna 2013-06-19 12:03
    - Population BE for in-vitro data Helmut 2013-06-19 18:24