BIOTECH PHARMA

The biotech pharma industry has hundreds of new drugs that are being tested to fight many different illnesses and diseases. A drug must go through a clinical trial before the Federal Drug Administration (FDA) will approve it for commercial distribution. In the biotech pharma industry, the clinical testing occurs in three phases most of the time.

The first phase (Phase I) of testing focuses on safety and there are three things that scientists need to learn: the best way the drug should be administered, what is a safe dosage level of the drug, and what is the targeted population who can show the best statistical significance in order for the drug to be approved. This is the initial phase of testing and most drugs usually pass this stage.

Phase II is the more difficult phase and most clinical trials fail here. In this phase, the targeted illness and patients are tested with the drug. The dosage is tested along with learning what the side effects of the drug are. Usually, a group of what could be hundreds of people are tested, some given placebos while others are actually receiving the drug. The results are compared, and if they show that with the optimal dosage the patient population benefits in a significant way, then the company will move on to the next phase. The drug’s side effects must also be presented.

In the final phase (Phase III) of a clinical trial in the biotech pharma industry, the drug is then experimented on thousands of people and tested against the standard treatment, if there is one already exists. It is compared to the current standard treatment to see if it outperforms that treatment. If no standard exists, then a baseline is measured. Phase III takes a few years before it is complete.

In the biotech pharma industry, after successful testing on thousands of patients, a Biologic License Application for the biotech drug must be filed. An advisory committee will then make a recommendation and it will be followed up by the Food and Drug Administration as being approved or denied.

The process of biotech pharma clinical trials happens in three distinct phases and the whole process can take many years before completion.

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