Question

please type your answer, I have trouble reading some of the people's handwrtiting.

1. Compare the various stages of drug development from in vitro studies to animal studies to human studies

2. Summarize at least two key pieces of legislation that govern the pharmaceutical industry.

3. Discuss how regulatory agencies such as the FDA work with pharmaceutical companies to ensure medications are both safe and effective for the public.

4. Summarize a recent current event where a drug manufacturer was sued by a state or federal agency. Focus on the nature of the allegations and outcomes of the lawsuit

Answer 1

1-) IN VITRO STUDY

Before drug development comes drug discovery, the process by which new candidate drugs are identified. Modern science helps researchers to understand how disease and infections are controlled at the molecular and physiological levels and to use that knowledge to create compounds that will be effective against the chosen targets (e.g., certain disease or infection).

The purpose of drug discovery is to identify a drug candidate: a molecule that targets the chosen disease selectively and effectively, and has favorable medicine-like properties. To find such a drug candidate, pharmaceutical researchers screen large libraries of chemicals for molecules with the necessary properties. Usually, a pool of potentially useful compounds (“hits”) is identified and narrowed down to identify more promising compounds (“leads”).

The next stage is called lead optimization, where the most promising molecules undergo further screening. At this stage, in vitro pharmacology assays are used to extensively optimize the biological activity and properties of the leads. In vitro pharmacology at the lead optimization stage of drug discovery generates high-quality data in a precise and timely manner, allowing researchers to identify the best compound for their chosen purpose. That compound will be the drug candidate that will go on to pre-clinical trials.

2-) IN ANIMAL STUDY

Animal testing is a vital part of drug development. A candidate drug is initially tested in isolated cells, tissue slices or organs. Studies in living animals show whether the drug works the same way inside the body as it did in the artificial environment of the laboratory. They also indicate how the drug effects the interactions between different cells and organs of the body. If a potential drug appears to be effective in animals, and passes initial safety screening, then it can be studied in human trials.

3-) IN HUMAN STUDY

Below, NorthEast BioLab attempts to put together a quick, easy-to-follow version of the FDA and U.S. government’s step-by-step process for new drug approval.

Phases & Stages

Step 1: Discovery & Development

Step 2: Preclinical Research

Step 3: Clinical Development

Step 4: FDA Review

Step 5: Post-market Monitoring

US Drug Development - Process Overview

The complexity in drug development has increased manifolds over the past 40 years, requiring preclinical testing, investigational new drug (IND) applications, and completed clinical testing before marketing approval from the FDA. Generally, new drug applications (NDAs) or biologics license applications (BLA) are reviewed comprehensively before approval, and then drug performance is resubmitted to regulatory agencies for post-marketing studies. The overarching goal is to bring more efficient and safer treatments to the patients as quickly as possible after a thorough medical evaluation.

Drug Development - Phases & Stages

There are five critical steps in the U.S. drug development process, including many phases and stages within each of them. We will discuss these different phases and stages to develop an in-depth understanding of the entire process. The five steps are –

Step 1: Discovery and Development

Step 2: Preclinical Research

Step 3: Clinical Development

Step 4: FDA Review

Step 5: FDA Post-market Safety Monitoring