وزارة الصحة
الإدارة العامة للصيدلة
دائـــــرة التسجيل الدوائي / / State of Palestine
Ministry of Health
General Administration of Pharmacy
Drug Registration Department
Bio-Batch Form For Bioequivalence Study
- Test Product Information
Trade name
Active ingredient(s)
API source(s) used in Biobatch*
Particle size of API used in Biobatch**
Strength(s) to be registered
Strength used in the study
Dosage form
Type of formulation (immediate release, modified release, …)
Expected production size
Biobatch information:
Batch production site
Batch size
Batch number
ManufacturerName
Manufacturing date
Expiry date
Assay content in the COA
*Attach C.O.A for manufacturer and source
**Attach Report of Analysis
- Tabulation for the Composition of the Proposed Formulation(s)
Master Formula Code No.
Component and Reference Standard / Function / Strength (label claim)
xx mg / xx mg
Quantity/Unit / % / Quantity/Batch / %
Total
- Approved Reference Product Information
Trade name
Active ingredient(s)
Strength
Type of formulation (immediate release, modified release, …)
Batch number
Expiry date
Manufacturer Name & site
Assay content in the COA
- Summary of in vitro Dissolution Studies (Attach Report)
Testing date
Apparatus
Speed of Rotation
Medium
Volume
Temperature
No. of Dosage Units used
Study Report No. / Test Product / At Buffer pH 1.2 Collection Times (minutes or hours) / At Buffer pH 4.5 Collection Times (minutes or hours) / At Buffer pH 6.8 Collection Times (minutes or hours)
Mean / Mean / Mean
C.V / C.V / C.V
ƒ2 / ƒ2 / ƒ2
Study Report No. / Reference Product / At Buffer pH 1.2 Collection Times (minutes or hours) / At Buffer pH 4.5 Collection Times (minutes or hours) / At Buffer pH 6.8 Collection Times (minutes or hours)
Mean / Mean / Mean
C.V / C.V / C.V
ƒ2 / ƒ2 / ƒ2
I hereby declare that the data mentioned above is the same as data sent for Bioequivalence Center and that included in registration file.
Signature of the Responsible Pharmacist Date
…………………… ……………………
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For the office use only
Registration Dept.Checked By
Name………………………………………….. .Signature…………..…………………
Date……………
Remarks……………………………………………………………………………………………………………………..