Questions related to Clinical Drug Development
Is a scenario possible wherein the drug exposure achieved in clinical studies surpass or exceed than the exposure achieved in nonclinical toxicity studies conducted of appropriate duration?
And if so, is the dose selection flawed in that particular clinical study?
And to address that kind of a situation, should more nonclinical toxicity studies be performed that test a higher exposure than what is expected in humans?
I want to test something after activation of glycolysis, therefore looking forward to drugs that can activate glycolysis easily. Will inhibition of mitochondria naturally activate glycolysis? If so, pls also provide me info about efficient drugs to do it. Thx a million in advance
Im currently working on writing up a report about the potential safety issues to be considered during the clinical drug development of an analgesic.
Any thoughts / papers / journals I could be referred to in this regards, would be of great help.
Many thanks in advance!
In order to put together an early Phase II study for a proposed anti-inflammatory analgesic (small molecule); where-in the non-clinical pharmacology data shows the compound works in a variety of pain and arthritis models, what are the possible indications that can be proposed for this study?
My thoughts are:
- Since non-clinical pharmacology data shows a positive effect in a variety of pain and arthritis models - would it be safer to propose somatic pain indications?
Would ankle sprain be a good proposal? (acute pain)
Or should I use Rheumatoid Arthritis itself as an indication (chronic pain).
For some indications, the primary outcomes are well-defined by the regulatory authorities, and so Im keen on going with the one for which it has already been defined. (not sure which one in this case).
Teneligliptin was launched in India in 2015. Theoretically, it is supposed to be more potent than other gliptins. However, clinical trials comparing its efficacy with other gliptins are not yet published.
I am trying to determine the type and number of animals which are typically used during the exploratory pre-clinical phases of drug development, particular in relation to the type and number of animals used for pre-clinical assessment of a single drug candidate.
Also are there any established regulatory guidelines as to how many animals are required for such pre-clinical work, perhaps as published by the FDA or EMEA?
Can anyone suggest Models that can reduce the product's cost in Europe (A vision shared recently by EMEA Executive director Prof G Riso)?
hi i wanted to ask, if i am developing a novel drug that targets a gene expressing a signalling protein in the mid brain, how can i test to establish how selective the drug is to binding to the gene?thanks
While selecting a drug and its dosage form for its in vitro dissolution method development and validation by HPLC, what are the things to kept in mind?
A new class of cholesterol drugs - the PCSK9 inhibitors - might reduce the risk of heart attacks and strokes, and some trials were recently presented demonstrating these evidences, but we do not have large populacional studies really showing it? What do you think? Is longer the time for regulatory agencies release this group of medications for regular use of the population?
Does your research promise a significant health-related breakthrough sometime in the future?
I’m trying to compose a timeline that projects new treatments and preventatives over the next century.
I’m interested in preventatives and treatments for all health problems including ones we don't yet suffer from.
The closer these events are, the better we can predict when and if they’ll make an impact, but I'm interested in the lot (and the fuzzy logic behind the predictions).
I've asked a similar question recently and I got a single good answer - but surely there's more than just one forward thinking researcher out there!
1. Have you heard of any health innovations that may become big next 100 years?
2. When are these expected to go 'mainstream' and why then?
3. Any predictions on impact size?
4. Do you have any references? They don’t need to be academic, but academic Is better.
5. Any other thoughts?
6. Do you want to receive this data once I’ve compiled it?
We are interested in an investigator-driven treatment study in children in Switzerland and would like to use amoxicillin versus placebo.
We have some problems finding the amoxicillin placebo (suspension and tablets or even better dispersible tablets). Does anyone have any idea?
Thanks for your help.
What are different chemicals (carcinogens) and its protocols to induce myeloid leukemia in animal model (rat/mouse)?
I am interested in seeing if anyone is aware of any specific testing methodologies or assays which might be used to detect specific side-effects in the early stage of drug development? Again does the FDA or EMEA have anything to say on the matter?
Drug induced Liver Injury is responsible for up to 30+ of project terminations in clinical development. Me and my team are developing a personalized cell model to investigate individual DILI.
Recent Terminations include Lilly's LY2886721 which caused Liver Enzyme Elevations.
Has anyone information on some more terminated candidates and their commercial availability?
While making dilutions of a drug from stock to working, I have been using cell culture media (which is without serum). I used to make the dilutions fresh, but I cited a protocol which says they made dilutions in complete cell medium, which means they added serum to the drug dilutions. I don't think this should be done, because the drug may get entrapped in serum proteins and interact. Moreover, such dilutions cannot be stored at -20 C. Is there anyone who can enlighten me as to whether the addition of serum is appropriate or not?
I think that analysis of particle size & shape using optical microscope should be included as one of the tests in the official monographs(e.g, BP & USP) for oral suspensions. I have seen during my work in drug quality control field that such test is important and can explain the physical characters of different oral suspensions & can help to confirm that the suspension passes or fails the pharmacopoeial requirements. What do you think ?
Seeing first hand all the different reactions patients have to medications and how these reactions can differ wildly when using the generic version of a medication. How can a medication be called a generic version if the adverse events experienced differ so much from the original medication? Could this be due to the other agents present in the medication and not the principal agent itself?