5 Stepped-Protocol for the Drug Development | Clinical Research Courses

Veena Dimak

The drug development process still remains one of the prominent areas that requires intensive research for creating effective pharmaceutical products. This pharmaceutical industry needs to be constantly upgraded with time to help human bodies adapt for novel diseases. Here are 5 steps that are followed to create the medicine or drugs following a set of protocols:

Step I: Discovery & development

New medications are typically discovered by experts/researchers. Thousands of chemicals may be suitable for advancement as a medical treatment at this point in the process. When a potential molecule is chosen for development, researchers do tests to learn more about:

·       Its prospective advantages and methods of operation.

·       The ideal dosage for the medication (such as by mouth or injection).

·       Toxicology is the term used to describe side effects or unfavorable outcomes.

·       How it differs depending on the gender, race, or ethnicity of a group of individuals.

·       How it interacts with different and similar medications and therapies.

Step II: Preclinical Research

Before testing a medicine on humans, scientists must determine if it has the potential to cause significant damage, often known as toxicity. There are two categories of preclinical research:

·       In Vivo

·       In Vitro

For preclinical laboratory investigations, the FDA requires researchers to follow good laboratory practices (GLP), as described in medical product development rules. Preclinical investigations are often small in size and they contain information on toxicity levels and dosage range.



Step III: Clinical Research

While preclinical research provides answers to fundamental issues regarding a medicine's safety, it is not a replacement for studies of how the drug will interact with the human body. The term "clinical research" refers to research that involves human investigations or trials. As the developers construct the clinical trial, they will evaluate what they aim to achieve for each of the Clinical Research Phases and initiate the Investigational New Drug Process (IND), which must be completed before clinical research can proceed.

A developer must have sufficient evidence from two major controlled clinical studies before filing a marketing application to end this procedure. Clinical research industry possesses great opportunities to potential professionals. Various professional courses are offered that help students become professionals in this field.

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Step IV: FDA Drug Evaluation

If a drug developer has proof from early testing, preclinical and clinical studies that a medicine is safe and effective for its intended purpose, the business can file a marketing application for the drug. The FDA review team extensively reviews every submitted medication data before deciding whether or not to approve it.


Step V: Post-Market Drug Safety Monitoring by the FDA

Despite the fact that clinical trials give valuable information regarding a drug's efficiency and safety, the drugs’ safety would still be unknown at the time of approval. As a result, the real picture of a product's safety changes during the months and even years that a product spends on the market.

Veena Dimak
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