As Dr. Hossain has pointed out, if the product is within its shelf life then you are saying it meets all specifications and, therefore, there is no regulatory rule that says you cannot use. In fact, you are saying this is a product you would allow on the market (within shelf life) so it should definitely be OK to use for a biostudy. But, setting regulations aside, let's look at strategy and risk. You don't say whether this "sample" you intend to test in a biostudy, is an approved formulation/marketed product, or one in development that simply has met specs you have thus far set for shelf life. For example, if this is a generic formulation not yet approved for which you intend to file and ANDA, and specs not yet approved, you have a risk that FDA might not agree with your specs upon review in the ANDA and, therefore, decide the product actually did not meet shelf life and that your biostudy is unacceptable. Also, while one should never be afraid to test their own product (!!!!), most firms would weigh the timing and cost of making a new batch of sample versus the timing and cost of having to repeat a biostudy if the biostudy failed all because the test product was "on the edge."
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Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com------------------------------
Original Message:
Sent: 09-Sep-2019 02:28
From: Mir Hossain
Subject: BATCH SELECTION FOR THE BIOEQUIVALENCE STUDY
As the product is within the shelf life , it must meet all the predefined product specifications. The near expiry test sample (DP) should not behave differently than the fresh test sample. Yes, some parameters might go change with age but definitely it should meet the shelf life specifications of the product which is in line with compendia / ICH requirements. So , to my understanding, there is nothing wrong to select old test sample (near expiry) for bioequivalence study.
Thank you
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Mir Hossain PharmD
Gulshan Model Town
Bangladesh
Original Message:
Sent: 08-Sep-2019 08:45
From: MANOJ PANIGRAHI
Subject: BATCH SELECTION FOR THE BIOEQUIVALENCE STUDY
Dear Members,
Can you please inform me, can we select 24 month old test sample (near to expiry sample) for the bioequivalence study.
In none of the guideline, i am not able to found the the selection criteria related to the age of the sample.
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MANOJ PANIGRAHI
Mr.
Gujarat, India Surendranagar Surandranagar
India
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