Drug Discovery Flow

Drug discovery is said to take more than 10 years before practical application, requiring long-term research and significant investment. In the processresource shortageand ...,Lack of advanced and specialized technology and appropriate assay systemsand furthermoreCumbersome application procedures for commercializationNumerous challenges must be overcome, including This article will explain the drug discovery process in an easy-to-understand manner.

Drug Discovery Flow and Research and Testing Details

Drug discovery is a long-term process that progresses in stages from basic research to non-clinical testing, clinical testing, and post-approval and post-marketing. At each stage, efficacy, safety, and quality are rigorously verified while developing candidate compounds into pharmaceuticals. This section provides an organized description of the flow and major research and testing activities.

basic research

Initial evaluation of pharmacopharmacology and ADME

First in basic research,Evaluate whether a candidate compound acts on its target in a pharmacodynamic studyThe drug is then tested for efficacy and safety. At the same time, the absorption, distribution, metabolism, and excretion (ADME) of the drug in the body are confirmed to establish efficacy and safety prospects. Appropriate evaluation at an early stage greatly influences the success rate of subsequent development.

Lead Optimization

Based on promising lead compounds,Improvement of activity, selectivity, safety, and pharmacokinetics through repeated structural modificationsWe will continue to synthesize and evaluate the compounds one by one. Through repeated synthesis and evaluation, we will overcome challenges one by one and refine the compounds to the optimum balance as drug candidates.

nonclinical study

ADME Evaluation

About the candidate compounds for development,Detailed assessment of absorption, distribution, metabolism, and excretion (ADME)to predict human pharmacokinetics. Repeated-dose behavior and potential drug interactions will also be examined to establish a final profile that will determine whether to proceed to clinical trials.

prescription of the efficacy of a drug

Using in vitro and in vivo models that mimic human disease statesThe data obtained in the non-clinical phase will be used to validate the efficacy and mechanism of action of the drug. Data obtained in the non-clinical phase are also important for dose setting and biomarker discovery, and provide the basis for predicting efficacy in the clinical setting.

Toxicity and safety testing

Single and repeated dose toxicity, reproductive and developmental toxicity, and safety pharmacology studies.Conducted under GLP standardsand evaluate the safety zone. Data must be obtained scientifically and in accordance with regulatory requirements to minimize risk when administered to humans for the first time.

IND/FIH Application

Compilation of non-clinical data,IND (Notification of Clinical Trial) is filed to start the clinical trial.The first human dose (FIH study) will be administered to the patient. The process then proceeds to the first-in-human administration (FIH study). Comprehensive documentation of quality, safety, and efficacy must be submitted, and close coordination with regulatory authorities in each country is essential.

clinical study

Phase 1

This is an initial clinical study to confirm the safety, tolerability and pharmacokinetics of the drug, mainly in healthy adults.Increasing doses in small and gradual stepsOften conducted as a FIH study, it is the starting point for clinical development.

Phase 2

For a small number of patients,Exploration of efficacy and ongoing evaluation of safetyThe following is a brief overview of the process. Appropriate dosing and administration methods are discussed to determine if the treatment is effective. This is an important step in determining whether to proceed to later stage development.

Phase 3

Large-scale validation of efficacy and safety in a larger number of patientsWe will Through comparative studies with standard treatments and placebos, we scientifically demonstrate the usefulness of the drug as a pharmaceutical product. This is the stage in which the final data that will serve as the basis for application for approval is obtained.

Application for Approval and Review

Clinical trial results and quality/non-clinical data are compiled and submitted to regulatory authorities for approval. Submissions are rigorously reviewed,Efficacy, safety, and quality are comprehensively evaluatedThe product will be approved by the FDA in the next fiscal year. Continuous safety measures, including post-marketing surveillance, are required even after approval.

Approval and sales start

Approval and NHI drug price standard listing

Once the product has undergone regulatory review and obtained manufacturing and marketing approval, it can be used in the medical field. In additionListed in the NHI drug price standards and priced under the public medical insuranceAfter that, prescribing and distribution at medical institutions will begin in earnest.

Post-marketing surveillance and testing

Even after the start of sales,Safety and efficacy continue to be confirmedThe company will be Post-marketing surveillance (PMS) to collect information on adverse drug reactions under real clinical conditions and additional studies will be conducted to ensure risk management. Long-term use and identification of rare adverse reactions will play an important role.