What is Clinical Drug Development?

1. What is Clinical Drug Development? Clinical Drug Development defines the entire process of bringing new pharmaceutical drug into the market after the discovery. It involves the drug discovery, pre-clinical research (microorganisms/animals) product development, and clinical trials on humans. medical research involving people to study clinical trials and detail information about drugs and its uses. is Clinical Research Courses The drug development involves 5 steps which are: 1.Discovery and Development 2.Preclinical Research 3.Clinical Research 4.FDA Review 5.FDA Post-Market Safety Monitoring Step 1: Discovery New drugs are discovered through: New technologies, provide new ways to target medical products to precise sites within the body or to operate genetic material. New visions into a disease process that allow researchers to project a product to stop or reverse the effects of the disease. Existing treatments that have unanticipated effects. Tests of molecular compounds to find valuable effects against any of a huge number of diseases. Development When researchers find a compound for development, experiments are conducted to gather information on: How it is distributed, absorbed, metabolized, and excreted. The finest dosage. Its benefits and mechanisms of action. Good way to give the drug in mouth or injection. How it effects on people (different groups such as gender, race, or ethnicity). Side effects that can often be referred to as toxicity. How it intermingles with other drugs and treatments.

2. Its effectiveness in comparison to the similar drugs. Step 2: Preclinical Research Before a drug testing on people, researchers find out the potential to cause serious harm, which is also known as toxicity. Preclinical research are of 2 types which include: In Vitro In Vivo FDA (Food and Drug Administration) needs researchers to use good laboratory practices (GLP), defined in medical product development regulations, for preclinical laboratory studies. These regulations set the minimum basic requirements for: study conduct facilities personnel written protocols study reports equipment operating procedures system of quality assurance for each study to help assure the safety of FDA- regulated product Preclinical studies are not very large but are provided with detailed information on dosing and toxicity levels. After the preclinical testing, researchers review the findings and come to conclusion whether the drug should be tested in people. Step 3: Clinical Research Clinical research orClinical Trials Course, are done on people. As the developers design the clinical study, they will deliberate what they want to achieve for each of the different Clinical Research Phases and initiate the Investigational New Drug Process (IND), a process must go through before clinical research begins.

3. Clinical research steps includes of Designing of a Clinical Trials Phase Studies in Clinical Research Investigational New Drug Process FDA Assistance FDA IND (Investigational New Drug) Review Team Approval Step 4: FDA (Food and Drug Administration) Drug Review If a drug developer has preclinical and clinical research evidence that a drug is safe and effective for use, the company can file a drug application to market. The FDA review team examines thoroughly all submitted data on the drug and makes an approval decision. FDA Review When FDA receives an NDA (New Drug Application), the review team decides if it is complete. The review team can refuse to file the NDA, if it is not complete. In case if it is complete, the review team has the duration of 6 to 10 months to make a decision for the approval of drug. The process includes the following: Review team members conducts a full review of the application. For instance, the statistician review clinical data and the medical officer, while a pharmacologist evaluations the data from animal studies. There is also a supervisory review, within each technical discipline represented on Clinical Research Institute and the team. FDA inspectors travel to clinical study sites to conduct a routine inspection. The Agency looks for evidence of manipulation, fabrication, or withholding of data. The project manager collects all individual reviews and other documents, such as the inspection report. This document becomes the record for FDA review. The review team issues a recommendation, then a senior FDA official makes a decision. Step 5: FDA Post-Market Drug Safety Monitoring

4. Clinical trials provide important information on a drug’s safety and efficacy, at the time of approval it is impossible to have complete information about the safety of a drug. Despite the severe steps in the process of drug development, limitations exist. Hence, the true picture of a product’s safety actually evolves over the months and even years. FDA reviews reports of problems with prescription and over-the-counter drugs, can decide to add cautions to the usage information and dosage of a drug, with the other measures for more serious issues.