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Clinical Research Courses

The drug development process still remains one of theprominent areas that requires intensive research for creating effectivepharmaceutical products. This pharmaceutical industry needs to be constantlyupgraded with time to help human bodies adapt for novel diseases.


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Veena Dimak

2 years ago | 2 min read

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

Step I: Discovery & development

New medications are typicallydiscovered by experts/researchers. Thousands of chemicals may be suitable foradvancement as a medical treatment at this point in the process. When apotential molecule is chosen for development, researchers do tests to learn moreabout:

·Its prospective advantages and methods of operation.

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

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

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

·How it interacts with different and similar medications andtherapies.

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 laboratoryinvestigations, the FDA requires researchers to follow good laboratorypractices (GLP), as described in medical product development rules. Preclinicalinvestigations are often small in size and they contain information on toxicitylevels and dosage range.

Step III: Clinical Research

While preclinical research providesanswers to fundamental issues regarding a medicine's safety, it is not areplacement for studies of how the drug will interact with the human body. Theterm "clinical research" refers to research that involves humaninvestigations or trials. As the developers construct the clinical trial, theywill evaluate what they aim to achieve for each of the Clinical Research Phasesand initiate the Investigational New Drug Process (IND), which must becompleted before clinical research can proceed.

A developer must have sufficientevidence from two major controlled clinical studies before filing a marketingapplication to end this procedure. Clinical research industry possesses greatopportunities to potential professionals. Various professional courses areoffered that help students become professionals in this field.

Refer to Clinical research courses with guaranteed placementoffered by TechnoBridge

Step IV: FDA Drug Evaluation

If a drug developer has proof fromearly testing, preclinical and clinical studies that a medicine is safe andeffective for its intended purpose, the business can file a marketingapplication for the drug. The FDA review team extensively reviews everysubmitted medication data before deciding whetheror not to approve it.

Step V: Post-Market Drug SafetyMonitoring by the FDA

Despite the fact that clinical trialsgive 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 realpicture of a product's safety changes during the months and even years that aproduct spends on the market.

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