Clinical trials are a crucial part of medical science which deal with pre-clinical and clinical evaluation in real time experiment. These trial are designed to assess the safety, efficacy and quality of the new product(Pharmaceutical Product) on human being.
Pharmaceutical product such as Medical Devices, Medicine and other Biological products.
Clinical Trial is basically divided into two parts,
1. Pre-Clinical Evaluation: Is the phase where the newly identified or potential molecules tested on the animals under the control environment.
2. Clinical Evaluation: It is the progression of pre-clinical evaluation in which whatever the information gather from previous study they will conclude and apply it on clinical evaluation on human being under the control environment.
NOTE: Clinical Trial is strictly under the regulatory guideline whether it the pre-clinical or the Clinical. for Guideline refer the official website.
Stage of Clinical trial,
1. Phase 0: It is also Known as the Exploratory trial.
- 10-15 human being are involve in this phase
- It generally finish with the 7 to 10 days.
- Basically in this phase, very small dose of drug (1/100) is given to the healthy participant to assess the Pharmacokinetic* and Pharmacodynamic* of drug.
- Check for any immediate safety concern because not entirely study where directly apply on the human being for the safety concern .
2. Phase 1: It is also known as First in Human trial, Basically the continuation of phase 0, In this phase basically we evaluate the safety and side effects of the pharmaceutical product.
- Around 20 - 100 healthy volunteers.
- Duration of the study will up to several months
- To determine the safe dose range and identify the potential side effects along with PK and PD.
Further phase 1 has two parts,
2.1. Phase1A
- Focuses on single ascending dose (SAD) studies.
- Tests the safety of a single dose of the drug.
- Focuses on multiple ascending dose (MAD) studies.
- Tests the safety and tolerability of repeated doses over time.
3. Phase 2: It is also known as the Therapeutic Exploratory Phase, In this phase Efficacy is the major concern of the product also side effects.
- Around 100 - 300 volunteers who have the disease or condition.
- Duration of the study is around several months to 2 years.
- To determine the efficacy of the drug along with monitor short term side effects
Further phase 2 have two parts,
3.1. Phase 2A
- To explore the optimal dose range of the drug.
- Focuses on pharmacodynamics(how the drug affects the body)
- Around 100 - 150 Volunteers involve in this stage.
- Help in eliminating the ineffective doses and determine the best dose for the phase 2B
- To evaluate the drugs efficacy of selective doses.
- Focus on Pharmacokinetic(Absorption, Distributes, Metabolizes, and Excretes)
- Around 200 - 300 Volunteers involve in this stage.
- Confirm the Optimal Dose for the phase 3
Comparison: Phase 2A vs Phase 2B
| Aspect | Phase 2A | Phase 2B |
|---|---|---|
| Objective | Dose-ranging studies | Efficacy confirmation |
| Participants | 100-150 | 200-300 |
| Focus | Pharmacodynamics (PD) | Pharmacokinetics (PK) |
| Key Outcome | Identify dose range | Confirm drug efficacy and dose |
| Goal | Eliminate ineffective doses | Proceed to Phase 3 trials |
4. Phase 3: It is also known as the Therapeutic Confirmatory Trial, basically in this phase to confirm the effectiveness on the larger population.
- Around 1000 - 3000 volunteers involve in this stage
- Duration is about 1- 4 year
- In this stage comparison new drug with existing treatment, also they check with drug interaction such as drug-drug, drug with food, drug with alcohol and so on.
5. Phase 4: It is also known as the Post-Marketing Surveillance, basically in this phase drug finally comes in the market were the drug is given to the local population and to evaluate the further effectiveness, safety of the product.
- In this stage the pharmaceutical company collect the information about ADR and based on that they will make changes in their product or might withdraw from the market due to the regulatory guideline
- Generally evaluating the long term effects of the drugs
- Continuous surveillance on product
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