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

Someone plagiarized this question and chegg is investigating

1 What is the most difficult part of drug development?

2 What step in the drug development is most costly?

Answer 1

1. The development of a new drug involves various steps and phases. The phases of drug development are as follows :

- phase l : This phase is related to discovery of a molecule that will target appropriate pathogen and destroy it.
- phase ll : This phase is related to preclinical trials on model organisms.
- Phase lll : clinical trial including testing of the drug on patient groups.

- phase lV : approval of drug by FDA

- phase V : monitoring of the effects of drug post marketing.
According to me the most difficult phase of drug development is the drug discovery phase. It is very difficult to develop a molecule that will target the disease component within the body and provide therapeutic benefits.
Various types pf biochemical reactions takes place within the body. These reactions are ery complex and involves interaction between various molecules such as protein protein interaction, oxidative phosphorylation, electron transport and ATP synthesis which are difficult to study and understand completely. With only limited amount of knowledge about various biochemicsl reaction discovery of a new molecule which help treat a disease becomes very difficult and time taking.
2. The most expensive phase of drug development is phase IV : clinical trial. This phase involves randomized trial on different patient population. The target group that participates in the clinical trial is very large ad consumes lot of financial budget. Providing medical care and drug delivery to target group rewuires huge sum of money. Also development of drug for these patients requires funds.