When you get ill, the chances are you will be prescribed or recommended some sort of medicine, drug or cream as treatment. This is the natural course of action in 21st-century medical care, but have you ever paid thought to how those medicines came into being?
Clinical trial manufacturing is a key part of the pharmaceutical creation process and is key to identifying flaws and issues with a drug so that it can be perfected before it is placed on the market. Here’s what you need to know about the process:
What is CTM?
When drugs are being manufactured, their properties and effects on humans must be assessed in order to ensure they are market safe. After initial preclinical research, which does not involve humans, clinical trials have five phases to pass through before a medicine is made widely available:
- Phase 0 – Drug is given to 10 to 15 people to assess how the body processes it
- Phase I – Drug is given to 15 to 30 people to assess what the best dose is, and what dose causes the fewest side effects
- Phase II – Drug is given to a larger group of people, often including cancer patients, to see if it works
- Phase III – Drug is given to 100 or more people to test its effects against the current, standard drug. This phase is needed for FDA approval
- Phase IV – Newly FDA approved drug is tested on potentially thousands of people to better understand benefits and rare side effects
With these trials in mind, it is clear to see why using experts in pharmaceutical product manufacturing is key to producing a quality and controlled new medicine.
What problems might arise?
It may become apparent that the dosage needed for a new drug to work is so high that it begins to cause side effects, or that rare side effects only found when the drug is tested on thousands of patients are so severe that safety related questions are asked.
These trials provide a number of challenges that a company must overcome, such as ethical questions, the time it takes to complete the trials and the high costs related to the process.
Who are the experts?
For a pharmaceuticals company to test and analyze their product, they require the assistance of experts in clinical trial manufacturing. With Avomeen, companies can assure that the formulation and manufacturing of a new drug goes smoothly and that problems are identified early in the CTM analysis and testing lab. By using such experts, they will also receive packaging and labeling support.
What products are manufactured in this way?
All new drugs should be tested to determine whether the treatment works, whether it is better than other treatments and whether it has side effects and is safe.
Generally, a drug without Phase III testing will not be approved by the FDA, although in certain places drugs without FDA approval are legally sold over the counter. It is always worth checking on the label or online to find out if a drug you are intending to use or that has been recommended to you has been approved in this way.