The litmus test of every drug development lies in its performance during the clinical trials. These performances are scrutinized by the FDA, US, before providing the drug license. Devised below is a comprehensive guide on clinical bioanalysis, Contract Research Organization (CRO), and the phases for New Drug Application (NDA) Submission.
Clinical Trials and NDA
Clinical trials are conducted to study the effect of drugs on humans to cure, manage, or prevent certain medical conditions. However, there are specific protocols that necessitate the initiation of a clinical trial only after a preclinical check or drug results on an animal is clearly understood.
Depending on the drug or device, drug developers should submit an IND or Investigation New Drug Application to health authorities such as FDA or EDA before beginning clinical research. The developers can initiate trials once the approval is granted.
Phases of Clinical Trial
It begins Phase 1 and proceeds through 2 and 3. If Phase 1 gives negative outputs, then steps 2 and 3 are not conducted. During positive and promising results in Phase 3, the drugs can be marketed through a New Drug Application.
More information on the phases are listed below:
|1||Pharmacology||Verifies Pharmacokinetic and Pharmacodynamic parameters|
|2||Exploratory||Safety and Efficacy of the drug|
|3||Confirmatory||Confirms the safety and efficacy of the drug|
|4||Post Marketing/ Surveillance||Observed after marketing of the drug|
A new concept of Phase 0 was introduced by the US Food Drug Administration (FDA), where a subtherapeutic dose is administered to 10 -15 subjects. The dosage is too low to cause any therapeutic effects. Though this phase is not mandatory, this new idea helps with understanding the success rate of the new medicine.
Every NDA application is submitted by the drug developer to obtain a drug license from the FDA. It is also necessitated by the FDA to ensure that :
- The new drug is safe and effective
- Benefits outweigh the known risks
Hence every application for NDA Submission should include:
- The details of the happenings during the clinical trial
- Ingredients of the product
- Results in animal studies
- Product behavior in the human body
- Aspects of its manufacture, processing, and packaging
Clinical Bioanalysis and Clinical Trials CRO
During the different phases of clinical trials, it is essential to monitor the drug levels in real-time subjects and adjust the dosage accordingly. It becomes crucial, especially while administering to non-healthy volunteers, where precision and accuracy form vital factors. Hence these clinical bioanalysis methods require central laboratory and logistics support. A Contract Research organization supports the new drug developers in the form of research services on a contractual basis. The Clinical CRO services such as NorthEast Bio Lab also help reduce costs incurred for companies while devising new drugs. These Clinical trials conducted in CRO with skilled and experienced scientists, managers, and technicians also help accelerate the trial timeline.