Hi everyone, I have a question related to MACO values.
There are two products, Product A and Product B. Product A is manufactured with 150 ug API in a small 2 mg tablet, and it is produced in batch sizes of at least 150,000 tablets. Dosage is two tablets of product A administered orally every 12 hours.
Product B has 25 mg API in large 250 mg tablets, and it is produced in batches up to 50,000 tablets.
Product B uses the safety factor of 1000 and Product A uses a factor that is 10 times the safety.
I am trying to find the parameters of TDD, MBS, SF, MDW for both product A and B.
I know that SF for Product B is 1000 and Product A is 10,000.
But I am having trouble getting TDD, MBS, and MDW. Isn’t TDD only contains the therapeutic dose without API? or API is also calculated TDD?
Then the batch size is 150,000 tablets for Product A but doesn’t MBS is the mg of each tablet so (150,000 x 2 mg)