Do the pharmaceutical companies publish a through protocol of the drug they sell?if yes how can we have access to them?
No, commonly Pharmaceutical Companies treat the manufacture as private (classified information). Even the process that they send to the Health Minister is currently a very simplified one. But you can try searching into the text of patents, scientific papers or thesis related to the product of your interest.
Patents published is the only official way to figure out the process or you need to locate any known pharmaceutical company may be it will help in good cause ...
You cannot find out the manufacturing process unless you work in there as a regulatory affairs or if the drug is already off patent, other companies will replicte it, tweak it to some extent, and you know how it is done if you have access to their lab or dossiers.
Dear Nesa, If you want to know exactly the process being used to manufacture a particular product you need to ask the manufacturer (and I guess it will not disclose the information) or you can ask the Drug/Medicines regulatory agency (which are not allowed to disclose this type of detailed information). At least within the European regulatory framework and also the WHO prequalification program, drug product manufacturers MUST include in the marketing authorization application the FULL details of the manufacturing process, including its validation as well as the executed batch manufacturing records. Depending on the dosage form and the drug substance you may experimentally acquire some data that will allow you to have a closer "idea" of the manufacturing process but you will still be missing a lot of details.
On the other hand, if you just want to manufacture a similar product there are several sources of information where you can search for (books on pharmaceutical manufacturing, formulation and product development) that contain both general, as well as specific formulas and manufacturing processes. Just ask "Dr. Google" or drop a line if you need some references.
I must confess that I have never come across to a patent describing a manufacturing process in such a way that would allow someone to manufacture a useful drug product (or even to successfully replicate the process).
Regards, Luis
The pharmaceutical companies publish only 1% information about their medicine. As I know, approved medicine is counted after double blind randomised placebo controled research. American president reject this condition to simplify the way from factory to market for medicine. In Europe I did not hear about this simplifation. Also I do not know any approved medicine during last 10 years.
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