Drug development process by bioequivalence studies and by using other steps.
Bioequivalence studies refer to the rate at which the active drug ingredients or active moiety are absorbed from the drug products at the time of drug action. In bioequivalence studies are done by comparing the applicant with systemic exposure of a test drug to that of the reference drug product. Two products in bioequivalence are assessed through Vitro experiments, clinical or pharmacodynamics, and pharmacokinetic profiles. Drugs are developed by progressing bioequivalence studies and after the approval from those studies, it is taken to the next step of the developing process.
Drug discovery and validation
Discovery work is the first step in the drug development process. In the discovery process, the company first chooses a molecule such as protein or gene, to get a targeted drug. A rigorous screening process is undergone to find an appropriate drug. Up to 5,000 to 12,000 molecules are given to potential drug candidates. The validate the target by checking the disease condition versus activity of molecules finally the drugs are developed.
Preclinical testing is the next step in the drug development process, the process is divided into two subcomponents such as in vitro and in vivo testing. in vitro testing, it progresses the drug molecules through the test tubes and also within the lab setting. Vivo testing examines the drug molecules on animals’ models as well as on other living cells. Safety is required so the FDA doesn’t allow the preclinical studies on human trials. Preclinical testing analyses the safety, bioactivity, and efficacy of the formulated drugs. At the time of studies, the investigation of New drugs and plans for clinical trial application is prepared.
Clinical trials in drug development
Phase 1 clinical studies involve mainly on drug absorption and elimination process from the body. This stage mainly focuses on safety and maximum doses are established. Phase 2 clinical studies evaluate the drug’s preliminary efficiency and profile regarding side effects that are noted down at this stage. Additionally, clinical pharmacology studies and safety are also included in this category. Phase 3 studies are the larger-scale clinical trials, for the safety and efficiency of the drug. Major preparation of drugs is made in the clinical study of 3 phases.
New drug application filling and PDUFA
In drug development procedure the seventh step is the simplest one, it is just filling a New drug application with the FDA. This is the most peculiar stage why because the FDA decides to approve or deny the drugs. It sometimes postpones the decision or makes the drug move to the next stage of development. FDA has two choices either approve the drug or it can request additional information required for the drug or cancel the drugs. A CRL states the drug insufficiency and exaggerate which place it lacks. They also offer suggestions on how to remedy the situation
The drugs are given approval according to the bioequivalence studies. This is done by measuring the concentration of the active ingredient in plasma, serum, and other biological fluids. These components are known for both generic and innovator products that are called by reference and test drugs.