CLINICAL TRIALS PHASE 3

 

INTRODUCTION: Efficacy and adverse drug reactions monitoring:  Researchers plan Phase 3 studies to prove whether a product deals an action benefit to a specific people or not. Sometimes known as pivotal studies, these studies comprise 300 to 3,000 volunteers. Phase 3 studies deliver most of the safety data. The previous study might not be able to detect less common side effects. But phase 3 studies are conducted on large number of volunteers and longer in duration, the results are more probable to detect long-term or uncommon side effects. Around 25-30% of drugs travel to the next phase of clinical research. If a drug developer has data from its previous tests, preclinical and clinical trials that a drug is safe and effective for its intended use, then the industry can file an application to market the medicine. The FDA review team comprehensively inspects all submitted data on the drug and makes a conclusion to approve or not to approve it.

NEW DRUG APPLICATION: A New Drug Application (NDA) expresses the full story of a drug molecule. Its purpose is to verify that a drug is safe and effective for its proposed use in the people studied. A drug developer must include all about a drug starting from preclinical data to Phase 3 trial detain the NDA. Developers must include reports on all studies, data, and analysis. Beside with clinical trial outcomes, developers must include Proposed labeling, Safety updates, Drug abuse information, Patent information, Institutional review board compliance information, Directions for use.

FDA Review: Once FDA obtains a complete NDA then FDA team of review may require about 6 to 10 months to take a pronouncement on whether to approve the NDA. If FDA governs that a drug has been revealed to be safe and effective for its proposed use, it is then essential to work with the developer for upgrade prescribing information. This is denoted as labeling. Labeling precisely defines the basis for approval and direction how to use the drug. Although, remaining issues required to be fixed before the drug to be approved for marketing. In other cases, FDA have need of additional studies. At this situation, the developer can choose whether to continue further development or not. If a developer distresses with an FDA decision, there are tools for official appeal.

RELATED;

1.  CLINICAL TRIALS PHASE I

2.  CLINICAL TRIALS PHASE II

3.  CLINICAL TRIALS PHASE 4  

4.  STUDY DESIGNS  

REFERENCES

CLINICAL TRIALS PHASE 4

 

INTRODUCTION: Post-Market Drug Safety Monitoring: Phase 4 trials are conducted when the drug or device has been approved by FDA. These trials are also recognized as post-marketing surveillance involving pharmacovigilance and continuing technical support after approval. There are numerous observational strategies and assessment patterns used in Phase 4 trials to evaluate the efficacy, cost effectiveness, and safety of an involvement in real-world settings. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive purposes or other reasons. Therefore, the true illustration of a drug‘s safety essentially requires over the months and even years that mark up a drug‘s lifespan in the market. FDA reviews reports of complications with prescription and OTC drugs, and can decide to add precautions to the dosage or practice information, as well as other events for more serious adverse drug reactions.

REFERENCES

DRUG DISCOVERY AND DEVELOPMENT

INTRODUCTION:  Most new drugs or drug products are discovered or developed through the following approaches:

1.  Identification or elucidation of a new drug target 

2.  Rational design of a new molecule based on an understanding of biologic mechanisms and drug receptor structure

3.  Screening for biologic activity of large numbers of natural products, banks of previously discovered chemical entities, or large libraries of peptides, nucleic acids, and other organic molecules; and

4.  Chemical modification of a known active molecule, resulting in a me-too analog.

MODULATION OF STEPS:  Steps (1) and (2) are often carried out in academic research laboratories, but the costs of steps (3) and (4) usually ensure that industry carries them out. Once a new drug target or promising molecule has been identified, the process of moving from the basic science laboratory to the clinic begins. This translational research involves the preclinical and clinical steps.

DRUG SCREENING:  Regardless of the source or the key idea leading to a drug candidate molecule, testing it involves a sequence of experimentation and characterization called drug screening. A variety of assays at the molecular, cellular, organ system, and whole animal levels are used to define the activity and selectivity of the drug. The type and number of initial screening tests depend on the pharmacologic and therapeutic goal. For example, anti-infective drugs may be tested against a variety of infectious organisms, some of which are resistant to standard agents; hypoglycemic drugs may be tested for their ability to lower blood sugar, among others.

The molecule will also be studied for a broad array of other actions to determine the mechanism of action and selectivity of the drug. This can reveal both expected and unexpected toxic effects. The selection of compounds for development is most efficiently conducted in animal models of human disease. Where good predictive preclinical models exist, we generally have good or excellent drugs.

Studies are performed during drug screening to define the pharmacologic profile of the drug at the molecular, cellular, organ, system, and organism levels. The value of these tests is highly dependent on the reproducibility and reliability of the assays. For example, a broad range of tests would be performed on a drug designed to act as an antagonist for a new vascular target for the treatment of hypertension.

At the molecular level, the compound would be screened for activity on the target, for example, receptor binding affinity to cell membranes containing the homologous animal receptors (or if possible, on the cloned human receptors). Early studies would be done to predict effects that might later cause undesired drug metabolism or toxicologic complications. For example, studies on liver cytochrome P450 enzymes would be performed to determine whether the molecule of interest is likely to be a substrate or inhibitor of these enzymes or to interfere with the metabolism of other drugs. Effects on cardiac ion channels such as the hERG

RELATED;

1.  STEPS OF CLINICAL TRIALS

2.  EXPERIMENTAL STUDY DESIGNS

REFERENCES