Question

12. Describe the timeline for preclinical and clinical activities (phases of clinical trial). In your description please include the objectives and population that is usually studied. For example, Pre-clinical time 1-2 years objectives are to establish pharmacology and toxicology profiles, develop drug formulation and secure authorization to test in humans, population is on animals.

Answer 1

SOLUTION;

PHASES OF CLINICAL TRIAL

There are preclinical and clinical phases are there.

Preclinical phase;In the drug development,also named preclinical studies and non clinical studies is a stage ofresearch that begins before clinical trial (testing in humans) can beginand during which important feasibility,iterative testing and drug safety data are collected.Preclinical study is a study is to test a drug ,a procedure or another medical treatment in animals.The aim of a preclinical study is to collect data in support of the safety of new treatment.

PHASES OF CLINICAL TRIAL;

PHASE 0;Phase 0 trials are the first clinical trials done among people.They aim to learn how a drug is processed in the body and how it affects the body.In this phase a very small dose of a drug is given to about 10-15 people.

PHASE 1;

Phase 1 trials aim to find the best dose of a new drug with fewest side effects.The drug will be tested in a small group of 15-30 patients.In this phase very low doses are administerd to patients.usually 100 healthy subjects enrolled in this phase.time period is about 1-1.5 years.

PHASE 2;Phase 2 trials further assess safety as well as if a drug works.The drug is often tested among patients with a specific type of cancer.Phase 2 trials are done in larger groups of patients compared to phase 1 trial.Usually 100-1000 patients are usually enrolled in the study.Time period is about 1.5-3 years.

PHASE 3;Phase 3 trials compare a new drug to the standard of care drug.These trials asses the side effects of each drug and which works better.Phase 3 trials usually enrolled 1000-3000 patients.

phase 4;Phase 4 TRIALS OR POST MARKETING STUDIES are usually used to test the new drugs approved by FDA.This allows for better research on short lived and long lasting side effects and safety.Usually large population above 3000 are usually enrolled in the study.Time period is larger than PHASE 3.