CharonY

Then kindly specify the point where I was factually incorrect. The issue is that you keep insinuating things but not specifying what you consider wrong and which context was missing. The only thing I can think of (with no help from your side) is that I said "no drop in quality" rather than "no significant drop in quality", which, as admittedly is a bit sloppy, though I assumed by now that most folks would know that in science lingo we do refer to statistical significance when we refer to differences. If that is your point of contention, which, I repeat, you have yet to specify, I see it more it fairly hypocritical that you demand increasing precision from someone while apparently no putting much effort into being precise yourself. Then how about being more precise in what you want to say. Your last post just adds to the confusion as, again, the selective quoting does not really change anything of the discussion and forces me to interpret what you intend to say. So let me put some final effort in to help you understand where I see that you might have misinterpreted things: It doesn't really- the guidelines are pretty firm on them meeting the stability requirements, unless there is a specific point you want to make that makes it relevant. For example they might require storage at high humidity or light for moisture or photosensitive drugs. Yet the same baseline has to be reached in terms of potency of the active ingredients. I have outlined that detains in the guidance document earlier, kindly refer to where you might disagree with them or how the quote you provided might supersede FDA regulations. Or do you mean any other specific parameters (see, you do not specify that, so I have to start guessing again) that are unrelated to drug quality (especially for accelerated testing) ? What other test protocols are you referring to here? Again, in the document the parameters are listed. I should also add there are certain intricacies regarding the methods, especially HPLC (which is still standard in many areas) can have trouble separating active ingredient from degradation products (though LCMS takes care of that). But IIRC for many drugs batch testing is allowable within +/- 10% for most drugs, except when there is indication that therapeutic effects change within that range (but I have not been involved in production testing, so cannot say for sure). That is true, but as pointed out repeatedly, the manufacturer has to make sure that there is no (statistically significant) drop in potency or other relevant quality indicators used for the approval. If you read the first couple of paragraph in your article, you would have seen that. It occured to me that you might be unaware that batches also have (allowable) variations. I.e. the point is that stability should be comparable to batch variations. This is totally irrelevant as we have already discussed that the true shelf life might extend beyond the indicated shelf life. The issue is (in case you have forgotten) whether manufacturer arbitrarily decide on the self life and purposefully put a shorter in to make a profit. I have pointed out that they cannot just decide on a date, rather have to do stability testing to ensure that during the indicated time period no loss of potency is observed. You keep insinuating that this is somehow incorrect, yet fail to point out what that is beyond providing quotes that do not appear to provide any additional context. Telling me to read what you wrote and not misinterpreting it seems really lazy at this point, I am afraid. It looks to me that you fundamentally misunderstand something but perhaps someone else can figure out what it is as I apparently am not able to interpret your writing the you want it to mean.

Freud is not really used in any relevant form as far as I can tell, but there are branches in psychology that admittedly have rather dubious frameworks. That being said, and I think I made the argument already somewhere, a bit difference is the high level approach of social and related sciences. Psychology straddles both words, with but all deal with high level of complexity and therefore tend to be more narrative. In a somewhat similar vein, many biological models are also more qualitative and predictions are only valid in small domains. But much is also semantics. Natural science is definitely a different beast compared to social sciences. But that does not necessarily make them not a science. At minimum, they provide falsifiable hypotheses that can be tested, though method-wise they are also more prone to methodological errors. Conversely, one can contort (not directed at anyone specific) arguments as much as one wants, but for example religious beliefs or spiritual enlightenment will ever be science.

Can you clarify what you attempt to argue here? If you read your posted article: That is what is being regulated and I have provided the regulatory requirements by the FDA. At this point it starts to look more like backpedalling of your original demand. I suspect that you assume that drugs lose potency the moment they hit the shelf and as such, stability testing as I outlined initially cannot be happening. And that assumption might be intuitive, but after presumably reading the regulatory demands and the FDA interpretation of the regulations I would have assumed that this assumption should have been modified. Instead, this looks a bit like doubling down by selective quoting.

An interesting study looks at factors related to COVID-19 refusal. There has been an ongoing debate whether hesitancy was fueled by lack of good information or whether there are other drivers. This study focuses on how folks process information and found an important impact in the form of deliberate ignorance: https://doi.org/10.1038/s41541-024-00951-8

I think event hat needs to be qualified, as to the former, men are likely to be successful in suicide. But women are more likely to attempt it. A recent study puts it at 1.78 odds ratio (https://doi.org/10.1016/j.jad.2022.05.096). This is roughly in line with studies dating back to the 80s (going as high as about 2.5 fold). One of the key differences is the type of suicide attempt. Women tend to try poisoning, which is very ineffective. Men tend to use more violent methods, especially guns. There is a link to violent behaviour, either against themselves or others, which is indeed a gender difference. Women are less likely to engage in such, for example. The tricky bit is to figure out the psychological impact and how it manifests in men vs women (I am sure there are studies out there, but I am unfamiliar with the topic). As mentioned, men more frequently engage in violent behaviour and are more likely to be both, perpetrator and victim. In women, there is an imbalance, especially when it comes to severe injuries. That being said, there is a very specific burden for men that are victim of abuse, which is related to toxic masculine ideals. I.e. the stereotype that strong men should just suck it up. But there is increasing recognition on this issue, luckily (though still not enough). But that points to yet another issue in gender differences in psychological impact. For example when it comes to dealing with trauma, it is likely that societal expectations color how individuals cope or fail to cope with it. Some studies looking at differences between trauma associated with accidents and victimization, it seems that women are roughly similarly affected by either form of trauma (which in itself is interesting), but men are more likely to have more negative self perception and other symptoms when confronted with victimization vs accidental trauma ( https://doi.org/10.1080/20008198.2021.1975952). Depending on study, women do seem to have an overall higher rate of symptoms, such as PTSD, but also tend to cope better than men. The narrative there has been that women are better at emotion-focussed coping (doi:10.1093/brief-treatment/mhn004). Of course, as these studies might be colored by societal expectations themselves (which can be an issue of psychological studies).

Not really. The indicated changes are considered not statistically significant and generally also applied to batch production. I.e. the product is still virtually indistinguishable from fresh products. In case you are not familiar with the concept, in most of biology and medicine significance is established at the 5% level. There might be exceptions for certain types of drugs, where threshold can be lower, but I believe that these are outside of the general guidelines. The main quality concession there is related to accelerated (i.e. high temperature) experiments, as long as potency is not affected. Or are you referring to something else, in which case please clarify as I am curious to see why you'd think that I am not reading (or understanding) what I post.

Yupp, often for initial approval manufacturers can provide shelf life data from production batches, provided they are reresentative and following the same guidelines. That data can sometimes only cover 12 month, but they can amend it after they make longer tests. There is a bit of a push to provide manufacturers with incentives to make longer tests or work within SLEP or similar mechanisms to prolong dates. But for longer periods at home storing conditions could complicate things.

Of course I can, at least for the US (I believe Health Canada is mostly following FDA guidelines, but am not sure). The requirements are outlined in the code of federal regulations specifically 21 CFR 211.166 outlines the general requirements for stability testing https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=211.166. Additional requirements are outlined in 211.165: There are also other passages of relevance (such the the regulation requiring expiration dates 21 CFR 211.137 and other regulations that I am not familiar with might also apply. The FDA is using these regulations and has built a set of requirements for the industry. A guidance document outlining the specifics (as per the FDA) can be found here: https://www.fda.gov/media/71707/download A significant change from the original formulation is considered if any of the following is observed during the stability study: In addition there are additional criteria, depending on the packaging. Note that they minimum test time is 12 months (or 6 under accelerated schemes). However, the industry standard is usually 2-3 years. The reason is, that (contrary to some assumptions in this thread) having a very short shelf life might make it difficult to sell. The reason why testing is rarely done beyond that is that as indicated in the guidelines, the testing has to be representative of the production. So if the manufacturer change packaging (in a substantial way) or formulation, they have to redo the whole process (meaning in many cases adding years to the process). So keeping it at the 2 years keeps things a bit more flexible. Also keeping the same schedule will result in ideally almost identical degradation profiles, without the need of additional statistical evaluation and one can basically just point at the previous approval. However, this is the reason why you might be able to find the same drug from the same manufacturer with different expiration dates. They may have tested one version for longer than another. I should add that there are relaxed requirements if the mechanism of degradation and its kinetics for certain drugs is very well known. Though in many cases folks tend to prefer to do empirical testing for their formulations to avoid arguing, if possible. It may depend on the specific types of pharmaceuticals. The areas where I am more familiar with tend to have more complex formulation requirements.

Well, except that the online cohort has resulted in a massive drop in abilities. IOW it just doesn't work as well as traditional teaching. First cohorts from the pandemic have arrived at universities and the results are dismal. We have been doing hybrid teaching for a little while and similar as during the emergency phase of the pandemic, remote students are consistently doing worse and it has been pretty much accepted learning loss is a worldwide phenomenon due to COVID-19. I will note that there are not a whole lot of studies out there, and few used standardized testing for cross-comparison. In fact, some simply used student scores during the pandemic, which is problematic, as remote teaching has resulted in a massive flood of cheating. In some cases you could see your questions posted online on certain websites in real-time.

The paper is poorly written and it seems that the journal is one of the weird predatory ones. Even accounting for a certain jargon in social sciences, this article has been especially unclear in its core concepts. Kindly add the last paragraph:

Except you made a series of factually wrong statements, without providing support. I mostly pointed out how the actual process works. I could point out to FDA guidelines, if requested, but the article with the quote you provided also has a paragraph highlighting the requirements (which, again, counters you original assertions).

Except of course that is not happening. Older statistics from 2009-2015 showed a median of less than one death from mass shootings in any European country and 18 per year in the USA. If you want to talk about psychology, it would suggest that Americans have a uniquely different psychological mindset than Europeans. One could extend that to gun violence in general. https://www.npr.org/sections/goatsandsoda/2021/03/24/980838151/gun-violence-deaths-how-the-u-s-compares-to-the-rest-of-the-world And looking at homicide rates, the US has a rate of 6.4/100,000. If we exclude mini-countries, the next highest Western European Country would be France with 1.56. The UK has 1.1 and Germany 0.82 (see wikipedia). In the US, the by far guns are the the murder weapon of choice (https://www.statista.com/statistics/195325/murder-victims-in-the-us-by-weapon-used/). I often feel that folks in the US, especially when they talk about shithole countries or how immigrants allegedly swamp European countries with violence and crime, vastly underestimate how things are in their own neighborhood. So no, other countries do not even come close with murders using alternative weapons. It is not necessarily the guns per se, but clearly, the cult around its use, and the convenience to kill (themselves and/or others), has created a situation that facilitates killings and, again, assuming that Americans don't have highly specific psychological issues, any discussions that tries to ignore a likely central aspect to it, is going to miss the mark. One can ask separate questions here. One is what facilitates violence in any form (bullying is at best only one factor and I suspect that there are so many aspects that trying to find simple narrative is largely futile). The second is why it leads to deaths and/or severe injury, which, given the title, seems to be the original question. I do believe that OP was started from a uniquely American perspective, assuming that somehow mass shootings or equivalent violence is a just part of the course, not realizing that the USA is an outgroup among developed nations.

How about not giving anyone easy access to guns as a starting point.

Yeah, to some degree, but as I mentioned internationals are just a small basis and in contrast to the US. I do not know the Norwegian system, but I think they only recently introduced fees (for public unis). Finland had it for longer, IIRC (around 2017 or so?) but it was still roughly half of what internationals pay in Canada or the US. It doesn't mean that it will stay that way, though the critical element is the base funding from the government. If it keeps pace with costs, I would assume that most European unis would stay course as catering to internationals would only have marginal benefits (and may be offset partially due to increase in administrative course). If, however politicians in their endless neo-liberal wisdom decide to make European unis more like the US, then they will also be in for bad decisions, I'd wager.

Shoot, another skill made obsolete, it seems.

Also the SLEP program is independent of the approval process- it was a cost saving measure and pharma companies have no incentives to start such studies by themselves (unless there was grant to do so- there might be). Then kindly quote the passage where the DOD states that pharma companies willfully shorten the lifetime by greed rather than by a lack of legislation to provide incentives for long-term testing. Specifically, kindly show the passage that supports your claims of: And while at it, please indicate what you mean with "average" in this context.

If you are asking about the process, there are field guides where you go through a kind of flow chart of plant characteristics and arrive at the correct species when you answered all the points. Usually they are writtten for ageographic region, though.

No, you are just misunderstanding how it works. Remember, manufacturer have to provide empirical data for the shelf life of their products and it doesn't make sense for them to figure out the max shelf life (which could be decades) before putting them to market. These are not randomly chosen, to bost sales. Though the market average is likely calculated to provide the optimum balance for profits. Remember, if they determine a longer shelf life, they might be wnle to charge more from their customers. Also, you might have missed the fact earlier in this thread that there is acclelerated program to dtermine longer shelf lives, which would run counter to your assumption that manufacturers want to minimize shelf life.

Actually, I think the main incentives for Unis in the US (and other countries with high tuition rates) for foreign students is to get more money. This incentive is largely absent in European countries (with some exceptions). Conversely, it is easier to build a diverse work group in the US (or Canada for that matter) than in many parts of Europe. Edit: I think it was mentioned before, but the defining difference is funding. In countries like Germany and France University entirely (or close to) funded by government. Conversely, in countries like Canada and USA, even public universities fund about 40% of their income from tuition and student services (e.g., dorms). As a consequence there is business incentives to advertise and cater to students. In Germany, about 70% of salaries goes towards faculty and research/teaching related staff and 30% to administration. In Canada and the US it is about 50:50 and in some cases non-teaching/research positions can go up to 60%. That is why students in the US have access to all kind of support services, whereas in Germany the support service was a mildly confused instructor for 1000 students.

It was quite on a different level, especially compared to the US. Heck, milions into sports teams are part of the effort to attract student, and generate endorsements. Every faculty in the US has advisers and recruiters that go out and attract students. Unless something massively changed, that was not the case in Germany or France.

Are they also present in empty wells?

Or having two sexes for the purpose of procreation.

I think you are confusing the regulations for food with those for medication. For the latter the manufacturer have to have potency testing done and the expiration date is the minimum guaranteed time where they retain potency. They could remain effective for longer. This has been discussed earlier in this thread, though. And roughly a year back.

Is that the tracking dye or is it there only after coomassie stain?

To be fair, a handful of those are actually quite fascinating. The placebo effect study adds an interesting element to the question how it works in the first place (while not fundamentally new, it does at more evidence how expectations mitigate perception). The dead trout study sounds like regular physics to me. Enteral ventilation is.... curious, but I wonder whether it might actually have an application (beyond situations when ventilators are missing).