DRUG DEVELOPMENT PROCESS

DRUG DEVELOPMENT PROCESS:

Drug development starts at R&D and ends at chemist. The process time are 12-15 years and cost around 10 thousand corers. At the starting of trial we start up with 30000 compounds and ends up with 10 compounds. On resultant compounds clinical trial begins.

Clinical trials:

PHASE-0 STUDIES: The first stage of clinical trial is Preclinical trials or phase 0 studies or animal testing (1.5-2 yrs.)- To find out toxicity of compound. Single ascending dose and multiple ascending doses are given to animals to know toxicity. This data is submitted to FDA to obtain IND (Navigational New Drug).

After IND approval we are eligible test drug on human this process will conducted in 3 phases.

PHASE-1: We will find out pharmacokinetic properties around 20-80 healthy volunteers. These studies are done to know the safety of drug.

PHASE 2: These are exploratory studies done on around 100-300 subjects. We will know the efficacy reconsidering the safety. These is done on target study population.

PHASE 3: these are large clinical trials on populations number in 100 to thousands of patients .these are done to show that new drug is both safe and efficacious n target study population if these are successful we will get NDA (new drug application) approval. This means the drug is ready for marketing.

PHASE 4: these are post marketing trials conducted to monitor long term safety of new drug after drug is already in market. 

CLINICAL DATA MANAGEMENT:

The sponsor and investigator and statistician will prepare the protocol or sponsor will handle the investigation to the CRO. Where CRO appoints the investigator and statistician .the investigator conduct the study as per protocol and collects the laboratory values of study subjects and the statistician designs the statistical plan as per protocol. The investigator will fill the CRF sends back filled CRF to data management team. Mean while the DM team will design the data base and data entry will done by 2 different people .2 people will enter the same information and third person will check the consistency of data the non CRF data like lab data will be loaded in to data base by data base loading or data loading. After data entered in to data base batch validation will be performed on data at regular intervals in order to find any miss matches or errors.

After data base is completely validated we lock and freeze the database so that we can prevent any further modification. After database is locked and freeze biostatic team will extract the database in to sas datasets.

BIOSTASTIC TEAM (BST):

BST comprises of 2 teams one is sas programmers other statistician . statisticians is responsible to analyze reports created by SAS programmer and draw conclusions based on the data. Sas programmer is responsible to create reports like TLF (tables,listings,graphs) which are created from derived datasets.