Innovative drug development process

This is a mind map about the process of innovative drug research and development, and its main contents include: marketing, new drug application, clinical research, clinical trial registration and application for IND, preclinical research, drug discovery and preliminary research.

Edited at 2025-02-07 10:09:16

Gavinnblake

Recent works View more works>>

Innovative drug development process

Gavinnblake

Recent works View more works>>

Recommended to you
Outline

Innovative drug development process

Drug discovery and previous research

Seriously found: Penicillin, propranolol

The active ingredients of natural compounds are obtained: artemisinin, paclitaxel

Existing breakthrough drugs as a pioneer

Endogenous active substances in the body are used as the guide

Finding drug metabolites

Discovered in drug synthesis intermediates

New use of old medicines: new indications

Combination chemistry and high-throughput screening

Obtained based on biomacromolecule structure design

Preclinical research

The process research and development department provides batches of raw materials for preclinical toxicology research, and the preparation department completes toxicological research in the simplest form of drug delivery

The process R&D department designs a more perfect synthetic route to meet the needs of phase I-III clinical medicine and commercialization

The preparation department optimizes the prescription process design, and conducts pharmacokinetics, safety pharmacology, and toxicology research during this period

Clinical trial registration application IND

IND: Application for clinical trials of new drugs

1. Drug development: drug discovery and screening, carrying out a series of synthesis processes, preparation processes, and quality research

2. Pre-IND meeting: inform the FDA in advance of basic information on drugs, preliminary research plans, including the current research status of the drug, preliminary research plans, preclinical toxicology and pharmacology, CMC, and review data on clinical trial plans outlines

3. Write IND declaration file package

4. IND review, the review results include three types: allowed clinical initiation, partial clinical restrictions, and clinical restrictions

Clinical research

1. Phase I clinical trials

Subject: Healthy volunteers

Number of test cases: 20-30 cases

Main purpose: to study the human body's tolerance to drugs, to understand the laws of absorption, distribution and elimination of drugs in the human body through drug metabolic kinetics research, and to provide data support for the formulation of drug delivery plans.

2. Phase II clinical trials

Subject: Patient

Number of test cases: ≥100 cases

Main objective: To study the safety and effectiveness of drugs. Placebo can be used as a control drug to evaluate the efficacy of new drugs. In this process, the impact of the disease development process on the efficacy of drugs is studied, and the dosage and regimen of Phase III clinical trials can be determined to obtain more drug safety. material

3. Phase III clinical trial

Subject: Patient

Number of test cases: ≥300

Main purpose: On the one hand, we should increase the number of subjects, and on the other hand, we should increase the time for subjects to take medication. Determine the ideal dosage regimen for different patient populations to further verify the effectiveness and safety of the drug

Note: After entering Phase III clinical trials, the production process of raw materials and preparations has been basically completely determined. If they change compared with Phase I/II clinical samples, such as dosage form, prescription, process, specifications, etc., it may affect product quality characteristics. Major changes

4. Phase IV clinical trials

Subject: conducted in multiple hospitals

Number of test cases: no less than 2,000 cases

Main objective: Strengthen monitoring during the actual application of new drugs after they are launched, and continue to examine the efficacy and adverse reactions in a wider and longer-term practical application.

New drug application

After completing the first three phases of clinical research, the safety and effectiveness of the drug are proven, and companies can submit new drug applications to the FDA.

Go on sale

It is not the end of the study, but another beginning, and its efficacy and adverse reactions need to be monitored continuously. The drug supervision department requires the modification of the drug instruction manual based on the test results of this stage.

It is necessary to study the compatibility and use of drugs and contraindications for drug use. If serious adverse reactions are found after the drug is launched, it will face the risk of being removed from the shelves.