Details required for a typical Bioequivalence / CT Study Report

Sr.
DESCRIPTION TEST REFERENCE
No.
Product name as per label (Brand or generic, as
1. applicable)

Dosage form, strength and pharmacopeia

2.
Formulation details – coating, IR or MR etc.
3.
Batch No. or Lot No.
4.
Mfg date
5.
Exp. date
6.
Manufactured by (Name and address)
7.
Sponsor/Representative name and address
8.
Label Claim as Each coated/uncoated tablet
9.
contains—equivalent to
Composition, if fixed dose combination
10.
Fasting / Fed
11.
Storage condition
12.
Certificate of analysis, if available
13.
Date of initiation of Biostudy
14.
How supplied (packaging details and pack
15.
size)
Quantification of analyte and/or metabolite
16.
Country name for dossier submission
17.
Whether regulatory authority will audit the
18.
clinical site