Question

If you are a Director R&D Clinical Studies

Please answer the following questions No Plagiarism please

Try to use approximately 100 words each question

Please type

Please do no plagiarize. If you don't know dint answer.

4.       What were the challenges in your past and present company?

5.       Can you describe the drug development process?

6.       What step is more promising/ challenging during drug development?

7.       Which step has more ethical issues and how have you overcome them?

8.       What do you suggest to people who want to pursue a career in clinical trials?

9.       How do we approach/ what aspect do we need to consider at the first step?

10.   What is the most difficult part of drug development?

11.   What step in the drug development is most costly?

Answer 1

4, There is low cost and less technology improvement increases high cost from out of pocket for this project. low technology improvement increase the timeline and lower the success rate for drug design, drug discovery for better clinical infrastructure. there was more burden in approval and reimbursement for approved drugs. society and regulations facing low-risk tolerance and there are financial issues of drug R&D. it needs more and complex research for new drugs target, so financial and technology issues main barriers to strengthen the innovation. there were problems strategic changes that cause less efficiency in research bases drug companies. poor government funding and less collaboration and partnership cause low access to project research targets, growth objectives by product innovation. licensing activity, growing clinical trial continuity regulatory burden, new trail difficulty remain unchanged challenges.
5, The Drug development process includes discovery and development for new drugs. focus on new disease process researchers make research to stop the effect of the disease makes more treatment option without adverse effects. using technology they target medical products development including research on mechanism of action, dosage, way of drug administration, side effects, effectiveness and interaction. Preclinical research make research with potential harm, toxicity before it reaches to people, .clinical research ensures drug safety, this trial was done in people it includes investigating new drug process with studies and get help from FDA guidance. FDA team review the new drugs and make approval, the clinical trial provides more information on drug efficacy and safety. generic drugs should be comparable to brand name drugs, it will not include a clinical trials for safety purposes.
6, The Drug development process is a more complex and costly process. The most challenging step in drug development process is preclinical research. researchers will not make direct research into patient populations before that they need to confirm to the toxicity and check whether biology animal study applied to healthy people. many tests conducted in the preclinical research process to ensure safety in animals and address the effect potential of the drug in development. it is a cost-effective process to ensure safety and efficacy.
7, when the preclinical trial supported a well-grounded hypothesis it show a high probability of success. it should address the concern with standards policy to protect vulnerable patients and increase success. ethical dilemmas arise when making experiment with humans when testing the safety of the drug that is ineffective in clinical trials. these regulatory models need ethical safe and ethical oversight, there may be ethical obligations fir sharing data and research results if it is failed. potential benefits to be ethical it should outweigh the harm. research needs adequate knowledge to make the ethical principles valuable. ethical consideration in a clinical trial when people with terminal and vulnerability should be out of desperation. it should target the patient to gain for minimum tested drugs or even untested and determine in which condition it will be appropriate to test.