ondulation t1_j2m5ghq wrote on January 2, 2023 at 9:52 AM

Reply to comment by aphilsphan 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

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.

aphilsphan t1_j2m6z9e wrote on January 2, 2023 at 10:13 AM

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.

ondulation t1_j2m8318 wrote on January 2, 2023 at 10:29 AM

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.

aphilsphan t1_j2naydh wrote on January 2, 2023 at 4:37 PM

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.