HOW A NEW DRUG IS DEVELOPED?
DRUG DVELOPMENT PHASE – Drug development is necessary as every year new disease epidemic occurs and without development of new drug we cannot fight with new situation related to disease.
Pre Clinical (non clinical) phase – this phase of drug occur in animals or in laboratory to see effectiveness of drug or medicine.
PHASE 1- This is first study of drug on human after seeing no side effect on animal, in this 20-80 healthy individual or with particular disease.
–To establish Pharmacokinetic (PK) and Pharmacodynamic (PD).
PHASE 2- This phase is for short term safety of using drug and determine dose, well define eligible criteria for participant and comparison of drug with Placebo drug.
PHASE 3- In this large group is taken for trial and result is use in the marketing and product labeling.
PHASE 4- After approval of drug from the FDA deal with post marketing strategies and studies.
Now we talk about phase of clinical trials, i.e how to check medicine effect on human.
PHASE OF CLINICAL TRIALS –
Phase 1 – in phase 1 we determine human pharmacology
-pharmacokinetics(PK) Like Absorption, Distribution, Metabolism, Excretion.
– Establish initial safety (pharmacovigilance)
– Determine safe dose range.
– In this study 20-80 healthy or patient individual are selected.
PHASE 2 – It is divided in 2 phase –
Phase 2a –important features are Therapeutic Efficacy.
-Up to 100 subject with narrow eligibility criteria.
– Dose tolerance maximum limit.
– Effect of concomitant medication.
Phase 2b – additional study methods like blinding, placebo, crossover, multicentric.
PHASE 3 – divided into 2 phases –
Phase 3a – Dose type, regime, interaction with food and alcohol are check.
-100 – 1000 subject are taken and analyses primary and secondary efficacy, safety.
Phase 3b – Pre approval study.
-Long term doseing, quality of life, compare the drug with other established drug.
Phase 4 – this post marketing study. compare a drug with other drug and it’s Pharmaco-economic value.
Just it’s that simple , see you soon with new topic. Bye