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Thread: How Do You Do a Trial When You Don't Have $$$$$ to Spend?

  1. #1 How Do You Do a Trial When You Don't Have $$$$$ to Spend? 
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    I have this cosmetic formula, e.g. spot reducing fat, but I don't have hundreds or even tens of thousands to do a clinical trial. The actives aren't anything mysterious, like chemicals that I synthesized in a lab, and I suppose it would be marketed as a supplement. If there is a way to do a decent non-clinical trial where the results would be acceptable to the massive majority of non-science people, including many science people, how would it be conducted?

    My goal is to convince people that it works, if it works. If it obviously works for a very large majority of people without a full on clinical trial, maybe this is just a marketing problem.


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    I don't know much about the business/marketing end of this, so i'll just comment on the clinical research part.

    First; is this formula an actual medicine? Without knowing details it's hard to say, but knowing what it's supposed to do might help. If you're not sure yourself and you're serious just e-mail the FDA/EMEA or MHRA (depending which country you're in). They're slow but usually helpful.

    If it's not a medicine then you don't have to run a clinical trial. However, hopefully, supplements may soon be subject to at least some trials before market.

    If you still want/need to do a trial there are some options. You could apply to various interested organisations for funding - charities, government (if the problem is deemed worthy), or companies.

    You could potentially run a small to moderate sized clinical trial without spending tens of thousands, but it really depends on what your product is, and how complex the design study would have to be.

    Bottom line, not enough info here to give a straight answer.


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    Perhaps make the theory sound. Work on all manners of detail of the theory and then use some kind of computer simulation to map the results. Find a company that would support the thesis and sponsor you with.

    As for the marketing its perhaps best to find the niche first, see what kind of people would be up for that kind of treatment and the isolate specific target markets that would be willing to test this new product. Primary research never fails, ask people on the internet what they think, walk the street and ask people that pass by. Also maybe find some kind of medicinal rally and share ideas with people, set up a stall and see what passers by think.

    If you can get them intruiged you can get them hooked.

    If your idea is incredibly useful and valid it might be a good idea to file a patent first.
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    Prometheus wrote:
    "First; is this formula an actual medicine? Without knowing details it's hard to say, but knowing what it's supposed to do might help. If you're not sure yourself and you're serious just e-mail the FDA/EMEA or MHRA (depending which country you're in). They're slow but usually helpful.

    If it's not a medicine then you don't have to run a clinical trial. However, hopefully, supplements may soon be subject to at least some trials before market".

    It's not a medicine and the actives don't seem to suggest at any dangers to health. it's partly transdermal. I'm not sure how that changes its perceived safety.


    Prometheus wrote:
    "If you still want/need to do a trial there are some options. You could apply to various interested organisations for funding - charities, government (if the problem is deemed worthy), or companies".

    I guess so, but I don't know why they would fund a study for a product for spot reducing fat.


    Prometheus wrote:
    "You could potentially run a small to moderate sized clinical trial without spending tens of thousands, but it really depends on what your product is, and how complex the design study would have to be".

    I'm not sure what makes up the high cost of clinical trials. I suppose a big one would be an outsourced researcher. What would be considered a small/moderate size?
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    Quantime wrote:
    Perhaps make the theory sound. Work on all manners of detail of the theory and then use some kind of computer simulation to map the results. Find a company that would support the thesis and sponsor you with.

    As for the marketing its perhaps best to find the niche first, see what kind of people would be up for that kind of treatment and the isolate specific target markets that would be willing to test this new product. Primary research never fails, ask people on the internet what they think, walk the street and ask people that pass by. Also maybe find some kind of medicinal rally and share ideas with people, set up a stall and see what passers by think.

    If you can get them intruiged you can get them hooked.

    If your idea is incredibly useful and valid it might be a good idea to file a patent first"

    Explain the theory and target the market segment to find testers. Great ideas. It's definitely difficult to find testers at this stage. I'm going to look into patenting for sure.

    Thanks Quantime
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    If I were to run a case study rather than a clinical trial, how many participants should I recruit to be convincing enough? I think I would only go ahead with the business if it worked >75% of the time.
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    Oh, it's a spot cream? I missed that bit.

    A case study would not be appropriate to answer your hypothesis ( i assume your hypothesis would be 'cream A removes more spots than cream B, or some such). You would need a randomised, preferably double blinded, trial - if you are serious about getting a truly scientific answer. Anything else is a fudge. You should test your product against the 'gold-standard' in the market, but plenty of pharma companies still test against placebo and advertise their results as amazing.

    The high costs go mostly into human resources (trial managers/designers, statisticians, research assistants...). You could do much of this yourself if you know how and are willing to put in some hard work.

    The trial size would be determined by a power calculation which takes into account anticipated size of affect or minimum clinically relevant affect, variation in the population and how much money you've got. Small to moderate sized trials; twenty up to a few hundred participants.
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    In America, the FDA has some authority over cosmetics. Perhaps your best option is to document your product thoroughly, do some preliminary testing (family, friends, etc) and then approach a cosmetic company.
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    Prometheus wrote:
    "A case study would not be appropriate to answer your hypothesis ( i assume your hypothesis would be 'cream A removes more spots than cream B, or some such). You would need a randomised, preferably double blinded, trial - if you are serious about getting a truly scientific answer. Anything else is a fudge. You should test your product against the 'gold-standard' in the market, but plenty of pharma companies still test against placebo and advertise their results as amazing.

    The high costs go mostly into human resources (trial managers/designers, statisticians, research assistants...). You could do much of this yourself if you know how and are willing to put in some hard work.

    The trial size would be determined by a power calculation which takes into account anticipated size of affect or minimum clinically relevant affect, variation in the population and how much money you've got. Small to moderate sized trials; twenty up to a few hundred participants"

    I'm afraid I don't know how to run a clinical trial. I thought it all had to be done by an independent party. I'm not even sure exactly what makes it 'clinical'.

    What do you reckon it could cost for a trial lasting 8 weeks, plus a follow up at 30 and 60 days, 30 subjects, 30 control subjects?
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    jrmonroe wrote:
    "In America, the FDA has some authority over cosmetics. Perhaps your best option is to document your product thoroughly, do some preliminary testing (family, friends, etc) and then approach a cosmetic company".

    Do you mean license/sell it to a cosmetic company? That is an option, just that if it does actually work, a super profitable business of my own could be beckoning
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    Quote Originally Posted by Chester
    Do you license/sell it to a cosmetic company? That is an option, just that if it does actually work, a super profitable business of my own could be beckoning
    You could patent it, but quite frankly, I'm not clear on how closely someone could copy your product of this kind without infringing on your design. If your product contains 40% Substance A, 30% Substance B, 20% Substance C, and 10% Substance D, then would a 45%/25%/25%/5% concoction infringe on your design or not?

    You could manufacture and/or distribute it yourself, or as you suggested, you could license or sell the patent to a cosmetic company.

    The first thing you should do is get/read a good book on developing inventions and filing patents in your country.

    The second thing is to be wary of invention developers and of companies that help you file your patent.
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    Yeah, patent infringements are a major potential problem. Whether I make it myself or license it, I will have to protect the formula somehow.
    Chester
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    Quote Originally Posted by Chester
    It's not a medicine and the actives don't seem to suggest at any dangers to health. it's partly transdermal. I'm not sure how that changes its perceived safety.
    In principle though, the possibility of benefit means that there is also the possibility of harm. A compound either does something or nothing, and in the absence of evidence there's no logical reason to assume that "something" is automatically benefit rather than harm.
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    Quote Originally Posted by jrmonroe
    You could patent it, but quite frankly, I'm not clear on how closely someone could copy your product of this kind without infringing on your design. If your product contains 40% Substance A, 30% Substance B, 20% Substance C, and 10% Substance D, then would a 45%/25%/25%/5% concoction infringe on your design or not?
    He would need to patent the range of useful formulations. Something like: "Between 30-50% A, 20-40% B, 10-30% C, and 5-15% D," or whatever ratios actually allowed the product to work.
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    Quote Originally Posted by TheBiologista
    Quote Originally Posted by Chester
    It's not a medicine and the actives don't seem to suggest at any dangers to health. it's partly transdermal. I'm not sure how that changes its perceived safety.
    In principle though, the possibility of benefit means that there is also the possibility of harm. A compound either does something or nothing, and in the absence of evidence there's no logical reason to assume that "something" is automatically benefit rather than harm.
    I don't know why but the FDA seems to let many transdermal products go on sale without clinical trials. However, these products never say much in the way of efficacy stated on their websites. Can't say I would be keen to use that strategy because I'd hardly sell anything!
    Chester
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    Quote Originally Posted by Scifor Refugee
    Quote Originally Posted by jrmonroe
    You could patent it, but quite frankly, I'm not clear on how closely someone could copy your product of this kind without infringing on your design. If your product contains 40% Substance A, 30% Substance B, 20% Substance C, and 10% Substance D, then would a 45%/25%/25%/5% concoction infringe on your design or not?
    He would need to patent the range of useful formulations. Something like: "Between 30-50% A, 20-40% B, 10-30% C, and 5-15% D," or whatever ratios actually allowed the product to work.
    Yes I'd use ranges. Although a competitor could still come along and simply add an ingredient I hadn't thought of.
    Chester
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    Quote Originally Posted by Chester
    Quote Originally Posted by TheBiologista
    I don't know why but the FDA seems to let many transdermal products go on sale without clinical trials.
    Because they have no legal authority to control them.
    Would you happen to know who does?
    Chester
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    Quote Originally Posted by Chester
    Yes I'd use ranges. Although a competitor could still come along and simply add an ingredient I hadn't thought of.
    If their "new" product is simply your patented product+another ingredient, they still wouldn't be able to make or sell it without your permission, since it will be covered by your patent.
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    Quote Originally Posted by Chester
    Quote Originally Posted by TheBiologista
    Quote Originally Posted by Chester
    It's not a medicine and the actives don't seem to suggest at any dangers to health. it's partly transdermal. I'm not sure how that changes its perceived safety.
    In principle though, the possibility of benefit means that there is also the possibility of harm. A compound either does something or nothing, and in the absence of evidence there's no logical reason to assume that "something" is automatically benefit rather than harm.
    I don't know why but the FDA seems to let many transdermal products go on sale without clinical trials. However, these products never say much in the way of efficacy stated on their websites. Can't say I would be keen to use that strategy because I'd hardly sell anything!
    If they've approved something without trials, it's probably because the product doesn't have enough of an active ingredient to have any plausible efficacy or do any harm. Very common tactic with cosmetics- add enough of Formula X that you can include it on your packaging, but not enough that it could ever actually do anything. Your skin has been evolving for a couple of hundred million years to specifically prevent foreign substances getting through it, so it actually takes high doses and often a lot of other helper compounds to do the job. In which case the FDA and similar RAs are all over it.

    Quote Originally Posted by MeteorWayne
    Quote Originally Posted by Chester
    I don't know why but the FDA seems to let many transdermal products go on sale without clinical trials.
    Because they have no legal authority to control them.
    How'd you get that idea? They regulate transdermal patches like nicotine and motion sickness patches. They're treated as combination device-plus-medication, same as things like drug-eluting stents. They actually require more awkward and time consuming regulatory control than either medications or medical devices alone, particularly when it comes to safety reporting. Topical cremes are treated the same as any other medication.
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    Quote Originally Posted by Scifor Refugee
    Quote Originally Posted by Chester
    Yes I'd use ranges. Although a competitor could still come along and simply add an ingredient I hadn't thought of.
    If their "new" product is simply your patented product+another ingredient, they still wouldn't be able to make or sell it without your permission, since it will be covered by your patent.
    Awesome. Hopefully this is totally true!


    Quote Originally Posted by TheBiologista
    If they've approved something without trials, it's probably because the product doesn't have enough of an active ingredient to have any plausible efficacy or do any harm. Very common tactic with cosmetics- add enough of Formula X that you can include it on your packaging, but not enough that it could ever actually do anything. Your skin has been evolving for a couple of hundred million years to specifically prevent foreign substances getting through it, so it actually takes high doses and often a lot of other helper compounds to do the job. In which case the FDA and similar RAs are all over it.
    Compounding pharmacists can create transdermal carriers to get small doses through the skin now, so I guess the FDA will be all over it. However, I don't have to have official OTC drug actives in it, so I can't be sure they will be. And there seem to be many trandermal products where the active probably penetrates the skin effectively yet the FDA gives them a pass.

    Quote Originally Posted by TheBiologista
    How'd you get that idea? They regulate transdermal patches like nicotine and motion sickness patches. They're treated as combination device-plus-medication, same as things like drug-eluting stents. They actually require more awkward and time consuming regulatory control than either medications or medical devices alone, particularly when it comes to safety reporting. Topical cremes are treated the same as any other medication.
    I read the FDA regulates transdermal patches as drugs, but I haven't read that they have the same level of emphasis on transdermal gels/creams. All patches that I know of are OTC/prescription drugs, but many transdermal gels/creams don't have drug status.
    Chester
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    Quote Originally Posted by Chester
    What do you reckon it could cost for a trial lasting 8 weeks, plus a follow up at 30 and 60 days, 30 subjects, 30 control subjects?
    I got a costing tool for clinical trials, we can go through it together if you like. It'll require a few assumptions and a basic outline of the trial design and is based on U.K. prices, but it'll give a ball park figure - PM me, i'll be free thurs/fri.

    As for the FDA, i'd recommend contacting them, they'll give you the definitive answer.

    Quote Originally Posted by Chester
    I'm not even sure exactly what makes it 'clinical'.
    The 'clinical' in clinical trial, although used in different ways, usually refers to a particularly methodology of assessing novel agents in humans.
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    Quote Originally Posted by Chester
    Quote Originally Posted by Scifor Refugee
    Quote Originally Posted by Chester
    Yes I'd use ranges. Although a competitor could still come along and simply add an ingredient I hadn't thought of.
    If their "new" product is simply your patented product+another ingredient, they still wouldn't be able to make or sell it without your permission, since it will be covered by your patent.
    Awesome. Hopefully this is totally true!
    Well, it's totally true in the United States. I can't promise anything for other countries, but I imagine it works about the same everywhere in that regard.

    But FYI, you need some evidence that it actually works for its intended purpose before you can patent it. You aren't allowed to file a patent application and then later see if it works or not; by the time you file for a patent, you're required to know that it works.
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    Quote Originally Posted by Scifor Refugee
    But FYI, you need some evidence that it actually works for its intended purpose before you can patent it. You aren't allowed to file a patent application and then later see if it works or not; by the time you file for a patent, you're required to know that it works.
    I definitely intend to know whether it works. How many testers do you think it would take to be able to say for certain that it works, assuming I do a non-clinical type trial? I have had extraordinary results with one tester so far, but I only really want to go ahead if it works for 75+% of all people who meet the criteria for using it.
    Chester
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  25. #24  
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    Quote Originally Posted by Chester
    Quote Originally Posted by Scifor Refugee
    But FYI, you need some evidence that it actually works for its intended purpose before you can patent it. You aren't allowed to file a patent application and then later see if it works or not; by the time you file for a patent, you're required to know that it works.
    I definitely intend to know whether it works. How many testers do you think it would take to be able to say for certain that it works, assuming I do a non-clinical type trial? I have had extraordinary results with one tester so far, but I only really want to go ahead if it works for 75+% of all people who meet the criteria for using it.
    Depends on the magnitude of the effect and the probability that it would be observed by chance. You'd need to do a power calculation, but typically you'll need several thousand subjects if you want to demonstrate efficacy to the satisfaction of most RAs. For patents... no idea, I imagine they set the bar lower.

    Quote Originally Posted by Chester
    Quote Originally Posted by TheBiologista
    If they've approved something without trials, it's probably because the product doesn't have enough of an active ingredient to have any plausible efficacy or do any harm. Very common tactic with cosmetics- add enough of Formula X that you can include it on your packaging, but not enough that it could ever actually do anything. Your skin has been evolving for a couple of hundred million years to specifically prevent foreign substances getting through it, so it actually takes high doses and often a lot of other helper compounds to do the job. In which case the FDA and similar RAs are all over it.
    Compounding pharmacists can create transdermal carriers to get small doses through the skin now, so I guess the FDA will be all over it. However, I don't have to have official OTC drug actives in it, so I can't be sure they will be. And there seem to be many trandermal products where the active probably penetrates the skin effectively yet the FDA gives them a pass.
    For example? Not saying there aren't loopholes or exceptions, I'm just not familiar with the specifics.

    Quote Originally Posted by Chester
    Quote Originally Posted by TheBiologista
    How'd you get that idea? They regulate transdermal patches like nicotine and motion sickness patches. They're treated as combination device-plus-medication, same as things like drug-eluting stents. They actually require more awkward and time consuming regulatory control than either medications or medical devices alone, particularly when it comes to safety reporting. Topical cremes are treated the same as any other medication.
    I read the FDA regulates transdermal patches as drugs, but I haven't read that they have the same level of emphasis on transdermal gels/creams.
    As far as I know, transdermal patches are normally treated as device+drug for new trials in the US. Would probably be drug only for european trials if the patch design itself is well-tested.

    Quote Originally Posted by Chester
    All patches that I know of are OTC/prescription drugs, but many transdermal gels/creams don't have drug status.
    Again though, I'd be surprised if you can find examples of these with demonstrated efficacy, or which make clear and testable claims of efficacy.
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    Quote Originally Posted by Chester
    How many testers do you think it would take to be able to say for certain that it works, assuming I do a non-clinical type trial? I have had extraordinary results with one tester so far, but I only really want to go ahead if it works for 75+% of all people who meet the criteria for using it.
    Sorry, no idea...I mainly deal with chemical patents, so I've never had to worry about clinical trial stuff.
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    Quote Originally Posted by Chester
    a competitor could still come along and simply add an ingredient I hadn't thought of.
    Yes, and as with domestic restraining orders, your patent would not be a brick wall.
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    Quote Originally Posted by jrmonroe
    Quote Originally Posted by Chester
    a competitor could still come along and simply add an ingredient I hadn't thought of.
    Yes, and as with domestic restraining orders, your patent would not be a brick wall.
    As already explained, no.
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    Quote Originally Posted by TheBiologista
    Quote Originally Posted by Chester
    Quote Originally Posted by Scifor Refugee
    But FYI, you need some evidence that it actually works for its intended purpose before you can patent it. You aren't allowed to file a patent application and then later see if it works or not; by the time you file for a patent, you're required to know that it works.
    I definitely intend to know whether it works. How many testers do you think it would take to be able to say for certain that it works, assuming I do a non-clinical type trial? I have had extraordinary results with one tester so far, but I only really want to go ahead if it works for 75+% of all people who meet the criteria for using it.
    Depends on the magnitude of the effect and the probability that it would be observed by chance. You'd need to do a power calculation, but typically you'll need several thousand subjects if you want to demonstrate efficacy to the satisfaction of most RAs. For patents... no idea, I imagine they set the bar lower.
    Let's hypothetically say forearm size permanently increased by 1-1.5" within 2 weeks in 75% of testers. For yourself, how many testers would be enough?

    Quote Originally Posted by TheBiologista
    Quote Originally Posted by Chester
    Quote Originally Posted by TheBiologista
    If they've approved something without trials, it's probably because the product doesn't have enough of an active ingredient to have any plausible efficacy or do any harm. Very common tactic with cosmetics- add enough of Formula X that you can include it on your packaging, but not enough that it could ever actually do anything. Your skin has been evolving for a couple of hundred million years to specifically prevent foreign substances getting through it, so it actually takes high doses and often a lot of other helper compounds to do the job. In which case the FDA and similar RAs are all over it.
    Compounding pharmacists can create transdermal carriers to get small doses through the skin now, so I guess the FDA will be all over it. However, I don't have to have official OTC drug actives in it, so I can't be sure they will be. And there seem to be many trandermal products where the active probably penetrates the skin effectively yet the FDA gives them a pass.
    For example? Not saying there aren't loopholes or exceptions, I'm just not familiar with the specifics.
    http://anabolicminds.com/forum/lg-sc...-lipoburn.html
    http://anabolicminds.com/forum/primo...ermatherm.html
    http://anabolicminds.com/forum/suppl...view-rpns.html

    Rosie has some scientific education from a Bachelor of Exercise and Sport Science, and was an elite level cyclist. The companies themselves don't seem to try and demonstrate efficacy.
    Chester
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    Whoa whoa whoa.

    I thought we were talking some sort of spot cream, as in acne treatment. It's comical just how far out i've been on this.

    My points were all general ones, so they'll still stand, but i'll revise the PM later.
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    Quote Originally Posted by Prometheus
    Whoa whoa whoa.

    I thought we were talking some sort of spot cream, as in acne treatment. It's comical just how far out i've been on this.

    My points were all general ones, so they'll still stand, but i'll revise the PM later.
    Sorry, not that kind of spot But I've been vague about what it is.
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    Quote Originally Posted by Scifor Refugee
    Quote Originally Posted by jrmonroe
    Quote Originally Posted by Chester
    a competitor could still come along and simply add an ingredient I hadn't thought of.
    Yes, and as with domestic restraining orders, your patent would not be a brick wall.
    As already explained, no.
    I meant that the patent you hold in your hand does not prevent me from infringing on it and selling the product. You'd have to sue me to get me to stop.
    Grief is the price we pay for love. (CM Parkes) Our postillion has been struck by lightning. (Unknown) War is always the choice of the chosen who will not have to fight. (Bono) The years tell much what the days never knew. (RW Emerson) Reality is not always probable, or likely. (JL Borges)
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  33. #32  
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    Quote Originally Posted by jrmonroe
    Quote Originally Posted by Scifor Refugee
    Quote Originally Posted by jrmonroe
    Quote Originally Posted by Chester
    a competitor could still come along and simply add an ingredient I hadn't thought of.
    Yes, and as with domestic restraining orders, your patent would not be a brick wall.
    As already explained, no.
    I meant that the patent you hold in your hand does not prevent me from infringing on it and selling the product. You'd have to sue me to get me to stop.
    True, there's no patent police unless the patent holder decides to take on that role.
    Chester
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  34. #33  
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    Quote Originally Posted by Chester
    Quote Originally Posted by TheBiologista
    Quote Originally Posted by Chester
    Quote Originally Posted by TheBiologista
    If they've approved something without trials, it's probably because the product doesn't have enough of an active ingredient to have any plausible efficacy or do any harm. Very common tactic with cosmetics- add enough of Formula X that you can include it on your packaging, but not enough that it could ever actually do anything. Your skin has been evolving for a couple of hundred million years to specifically prevent foreign substances getting through it, so it actually takes high doses and often a lot of other helper compounds to do the job. In which case the FDA and similar RAs are all over it.
    Compounding pharmacists can create transdermal carriers to get small doses through the skin now, so I guess the FDA will be all over it. However, I don't have to have official OTC drug actives in it, so I can't be sure they will be. And there seem to be many trandermal products where the active probably penetrates the skin effectively yet the FDA gives them a pass.
    For example? Not saying there aren't loopholes or exceptions, I'm just not familiar with the specifics.
    http://anabolicminds.com/forum/lg-sc...-lipoburn.html
    http://anabolicminds.com/forum/primo...ermatherm.html
    http://anabolicminds.com/forum/suppl...view-rpns.html

    Rosie has some scientific education from a Bachelor of Exercise and Sport Science, and was an elite level cyclist. The companies themselves don't seem to try and demonstrate efficacy.
    Just skimming the first product there.. it appears that it doesn't do anything, at least according to the reviewer. So I suspect that it falls into the category of not having enough of any active compound in it. You presumably are planning to create a functioning product. You'll need to play by the RA's rules if you want marketing authorization. In the US, that means the FDA.
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  35. #34  
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    Most patent holders are really happy when someone infringes their patent, because it means they get to make money suing someone...
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  36. #35  
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    Quote Originally Posted by TheBiologista
    Just skimming the first product there.. it appears that it doesn't do anything, at least according to the reviewer. So I suspect that it falls into the category of not having enough of any active compound in it. You presumably are planning to create a functioning product. You'll need to play by the RA's rules if you want marketing authorization. In the US, that means the FDA.
    Hopefully I can do what these companies did and avoid having to do clinical trials upfront. I don't mind doing one once I'm up and running and getting decent sales.

    Quote Originally Posted by Scifor Refugee
    Most patent holders are really happy when someone infringes their patent, because it means they get to make money suing someone...
    I won't be too happy if it happens right away because I doubt that I'd have the money to pay lawyers to go after them
    Chester
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  37. #36  
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    Would anyone know the difference between a normal claim and a 'medical claim'?

    http://fashion.telegraph.co.uk/beaut...ing-older.html

    "Under regulations that govern the cosmetics industry, however, the companies are not allowed to make medical claims about their products without obtaining a drug licence through expensive and time-consuming clinical trials. But in a move is likely to blur lines between cosmetics and pharmaceuticals even further, both P&G and L'Oreal are now carrying out clinical trials on products that could allow them to make medical claims about their effects. L'Oreal has been carrying out trials on an anti-cellulite lotion, while P&G has been testing a cream that counters the effects of ageing from sun exposure.

    Newby Hands, beauty director of Harper's Bazaar , believes that cosmetics companies need to cut through the smokescreen of pseudo-scientific babble and present their products to an increasingly savvy audience in an honest way. "These days, people are not going to use products unless they actually work, so cosmetics firms need the credibility that science gives them. The science being used by cosmetics companies is impressive, but the way that is then twisted by marketing people is mischievous.

    "Increasingly, we are seeing products that do more than the cosmetics companies are permitted to say, because they cannot make medical claims about their products." "
    Chester
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  38. #37  
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    Quote Originally Posted by Chester
    Would anyone know the difference between a normal claim and a 'medical claim'?
    http://www.fda.gov/food/labelingnutr...ms/default.htm
    http://www.fda.gov/Food/LabelingNutr.../ucm073992.htm


    http://en.wikipedia.org/wiki/Health_...on_food_labels


    See here for a page where they actually list several examples: http://www.fda.gov/MedicalDevices/Re.../ucm111124.htm
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  39. #38  
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    Quote Originally Posted by inow
    Quote Originally Posted by Chester
    Would anyone know the difference between a normal claim and a 'medical claim'?
    http://www.fda.gov/food/labelingnutr...ms/default.htm
    http://www.fda.gov/Food/LabelingNutr.../ucm073992.htm


    http://en.wikipedia.org/wiki/Health_...on_food_labels


    See here for a page where they actually list several examples: http://www.fda.gov/MedicalDevices/Re.../ucm111124.htm
    Thanks very much for the info inow. Looks like my product would be a drug since it changes the structure of the body. Luckily, I found out that if I use FDA approved non-drug ingredients it would probably be seen as a supplement/cosmetic like the other products in the industry.
    Chester
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