Question

f 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 please don't answer

1 What is the most difficult part of drug development?

2 What step in the drug development is most costly?

Answer 1

1) Ans)Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery
Drug target and candidate selection are two of the key decision points within the drug discovery process, and all firms use certain selection criteria for decisions on which targets to accept into their discovery pipelines and which compounds will proceed to the development stage

The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population.

Clinical research can be one of the most important steps in a drug’s development. If a drug is cleared from preclinical trials, it moves on to clinical testing which involves human trials. Drug companies and the FDA have specific standards for clinical trials which include the professionals involved in the scientific testing, the selection criteria of the humans being tested, the setting in which the clinical tests take place, and more. Clinical trial registration is also required and heavily followed by pharma professionals across the sector.

2) Ans)Drug Development Phases

Phase 1: Discovery and Development.

Phase 2: Preclinical Research.

Phase 3: Clinical Research.

Phase 4: FDA Review.

Phase 5: FDA Post-Market Safety Monitoring

Phase 1: Discovery and Development

Each drug begins with discovery and development in a lab. Pharma companies spend millions of dollars on research and development that includes scientific study and development of drugs for new innovation.

Phase 2: Preclinical Research

Once a drug discovery has been made it must go through both preclinical and clinical research with supporting reports tied to its review process. Preclinical research is a basic preliminary phase that involves testing the drug on animals and basic testing for safety flags.
Phase 3: Clinical Research

Clinical research can be one of the most important steps in a drug’s development. If a drug is cleared from preclinical trials, it moves on to clinical testing which involves human trials. Drug companies and the FDA have specific standards for clinical trials which include the professionals involved in the scientific testing, the selection criteria of the humans being tested, the setting in which the clinical tests take place, and more.

Phase 4: FDA Review

The Food and Drug Administration is one of the primary regulators involved in all aspects of the drug market.

Phase 5: FDA Post-Market Safety Monitoring

There are several aspects of post-approval safety monitoring for a marketed drug. The FDA monitors all types of drug advertising for accuracy. It also monitors complaints and problems associated with a drug. As such it has the power to limit drug sales and/or offer warnings. In general, the FDA also does routine manufacturing inspections. Furthermore, the FDA is involved in the patent protections and generic drug transitions of all drugs.

According to the Tufts Center for the Study of Drug Development, the cost of developing just one drug — from preclinical testing to market approval — stands at an estimated $2.6bn, with clinical trials being by far the most expensive factor.

Clinical trials form a vital part of drug development. Throughout the process, physicians test new drugs on carefully selected patient cohorts to establish the safety, efficacy and clinical benefits of these drugs.

Pharmaceutical innovation has never been healthier. Thanks to rapid advances in science and technology, researchers and clinicians are able to harness tools to capture vast amounts of data at near-zero cost, all while gleaning crucial new insights into previously unreachable areas of disease and disease variants

Clinical trials are research studies involving human volunteers. Most clinical trials are conducted to test novel pharmaceutical treatments and are undertaken in a series of steps called ‘phases’. If a new treatment is successful in one phase, the trial moves onto the next phase. There are three main phases of clinical trials: safety, efficacy,clinicalbenefit