I'd like to know how far should I go with regard to the effect? For example, we know that bisoprolol reduce the heart rate, so, lets assume this is the only known effect that has been shown through studies. So, based on this piece of info, should I conclude other parameters to assume safety of this medication, like I may conclude it will affect the blood pressure, etc..? Or only this piece of info, along with adverse reactions sufficient for safety? I'm interested to know this, because natural products aren't subjected to many studies, so the only available data are just few pieces of info. So, when considering safety for any natural product, will I have to conclude other facts based on the known effect? or the only known piece of info.along with the adverse reactions are sufficient for safety?
I think, it depends an intended biological activity and side effects of the substance. If the side effect will prevent to the effectiveness of the main biological activity it should be studied at the same time. Side effects can be cytotoxic, antithrombotic effects and etc.
Dr.Nodirali, may you explain in more details? So, How can I translate what you have said into practice? What steps should I follow?
Dear Mustafa,
As you know, all drugs have to pass preclinical studies before clinical trials. In these studies, both in vitro and in vivo tests will be performed. Studies of a drug's toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction.
According to the dose-dependence main biological activity of your compound you should check other related effect ("side effect") in these doses (in concentration). If your compounds main activity is much higher than the side effect, it means the drug has good therapeutic effectiveness.
Please, search and see the steps to follow in pre-clinical development of drugs
https://en.wikipedia.org/wiki/Pre-clinical_development
Dr.Nodirali, I'm interested in Daflon product in the meantime. And there are new studies that are suggestive of another therapeutic activity, but therapeutic activity can be harmful, and this is according to the context. Like in the case of Bisoprolol, it slows heart rate, so those with tachycardia would benefit, but those who have bradycardia will be subjected to Harm. So, my point is, how can I be certain of the safety of the product given that there are new beneficial effects (could be harmful) that are discovered continuously?
Dear Mustafa,
Of course, the drug developers should be avoided from not all but at least that opposite effects (although that effect will beneficial in the special case) related to that organ or system and show them in the drug safety instruction. In your example, it have to be studied Bisoprolol effects in both tachycardia and bradycardia models and on basis of this studies show that Bisoprolol is not recommended for patients with bradycardia. Yes, you are right, the drugs should be studied for the another side effects continuously, may be not by developers but by others (by clinicians and so on). That is why, there are so many examples, that the drugs were terminated in the final clinic trial stages.
So Dr.Nodirali, to put this into practice with regard to Daflon (Natural product), I have to just check the side effects, and contraindications and this will be sufficient with regard to safety? Right?
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