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aphilsphan t1_j2l2xuq wrote

Reply to comment by scottyboy218 in When pharmaceutical companies develop new prescription drugs, do they test every method of delivery to the human body? For example, injected, orally, topically, rectally, etc? by scottyboy218

To answer your question in the simplest way, every difference in dosage form is a separate New Drug Application (NDA) in the USA. The process is usually called a license application or Marketing Authorization elsewhere, but the processes are broadly similar. In one NDA, you could say, “we are going to offer this in 5, 10 and 20 mg capsules…” and you’d need to justify why those are the sizes.

You can reference information from one application in another. If the same impurities were in a capsule and oral liquid for a drug, and both hit the bloodstream the same way, you don’t have to repeat the tox study on the impurities.

I should point out that in the days when everything sent to an agency was on paper, forests trembled at the size of these filings. Now they are electronic and are even bigger.

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ondulation t1_j2m5ghq wrote

They used to be about a truckload of paper. That included a couple of copies for the reviewing agency’s convenience.

The ones I work with nowadays are around 100.000 to 1.000.000 pages as pdf.

To be honest, most of those pages are tables tabulating detailed test results (eg every single blood test taken in every study). Those are then summarized to more high level documents which are fortunately shorter.

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aphilsphan t1_j2m6z9e wrote

I used to prep drug master files for the API. They’d be smaller of course, but still with three copies printing, etc was a chore. And yes, a lot of it was executed batch records and the environmental statement, which i guarantee no one ever read.

I once accidentally discovered a note in the middle of one I was compiling yelling at my group for monopolizing the printer. It could easily have gone to FDA. I would’ve loved to get that deficiency letter. “Please explain the copier/printer drama…”. Same guy who put in the note made a complaint about me to HR because I let the FDA ask him a question on a tour. (We were a small shop.). They had to explain the law to him. He was still pissed. “Hey, bud I answer their questions 8 hours a day, you can answer one about a lab balance.” Good times.

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ondulation t1_j2m8318 wrote

I appreciate that story!! I’m sure the FDA must have received lots of copier drama without even knowing it.

Made me remember someone who accidentally sent their yearly development plan to the authorities in a handful of countries. Not her best working day.

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aphilsphan t1_j2naydh wrote

I got one or two of those. I felt honor bound to delete them. We were a smallish business but part of a pretty big company. Some of our customers were enormous. Once when discussing a newly identified but inconsequential impurity with an enormous pharma, they got into a big internal fight in front of us. Ok one time. But it was every week.

Same company berated us for missing a particle size spec we didn’t know existed. They had a senior VP on the call to yell at us. He realized they had added the spec without telling us and yelled at his people in front of us. Pharma can be nuts.

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