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In the stability tests; Bracket design Matrix design

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(1)

In the stability tests; Bracket design

(2)

Stability test protocol

• prepared for drug / preparation • Storage conditions

• Sampling plan • Test periods

(3)

• Test method

• Validation of methods

• Drug and excipient technical essence / source • Type, size and number of series taken

• Test parameters

• Acceptance criteria

(4)

Stability test protocol

• Statistical evaluation • Results

• Repeat process of test if necessary • Specified shelf life

(5)

Physical stability test parameters according to dosage forms

solutions

suspensions

emulsions

(6)

• Solid drug forms

• Reconstitute oral powders • Hard gelatin capsule

• Soft gelatin capsule • Tablets

• Coated tablets

• Parenteral preparations

(7)

• Semi-solid drug forms

• Topical preparations (ointment, cream)

• Transdermal preparations

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