On December 20, the official website of the Drug Review Center (CDE) of the State Food and Drug Administration released the "Technical Guidelines for Clinical Pharmacology Research of Innovative Drugs" (hereinafter referred to as the "Guiding Principles"), which specifically elaborated on the research content and research methods of clinical pharmacology, and the document will be implemented from the date of promulgation.
With the continuous change of technology, the Guiding Principles mention that the clinical pharmacological research of innovative drugs is no longer limited to clinical pharmacokinetics (PK) studies, but will be combined with the dose, exposure, biomarkers, and clinical endpoints of innovative drugs (including efficacy and safety endpoints) for quantitative analysis. The first financial reporter learned that at present, Siemens Medical and Lianying Medical have launched large-scale medical equipment, which can clearly see the changes in the body of the drug, and broaden the research horizon of clinical pharmacology to a certain extent.
In fact, model-informed Drug Development (MIDD) can be used before drugs are ingested into the body.
"In the entire clinical research process before the launch of innovative drugs, the model-guided drug development model can be used, continuously accumulate research data, and timely analyze the dose-exposure-responserelationship (D-E-R relationship) and its key influencing factors to provide a basis for subsequent research and development and registration, including the selection of optimized target indications/subpopulations, dosage, etc." Referenced in the Guiding Principles.
Continuous refinement of the impact indicators of drug safety and effectiveness is the main manifestation of the standardized development of the field of new drug research and development. The Guiding Principles recommend that, in addition to studies in pediatric populations and patients with hepatic/renal insufficiency, clinical pharmacology studies of innovative drugs should also consider studies of the elderly, pregnant, lactated, other organ insufficiency, and sometimes genetic pharmacology studies.
When referring to the results of clinical pharmacology studies, the internal and external factors affecting the characteristics of drug PK should be comprehensively analyzed, including but not limited to age, sex, weight, race, drug interactions, etc.
As a result, modeling and simulation techniques will be used in drug development to demonstrate great advantages, simulating the interaction between multiple internal and external factors. Experts from the drug process research and development of innovative pharmaceutical companies told the first financial reporter that the company can set different parameters through modeling and simulation systems, and simulate the changes of drugs in different situations in multiple dimensions. For example, through the simulation of drug dosage, the equilibrium point or acceptable interval is found in it, and then specific experiments are carried out after simulation to verify. This operation greatly improves the efficiency of research and development.
The reason why clinical pharmacology research is important is because this link runs through the whole life cycle of innovative drug research and development, registration and listing, which helps to understand the process and mechanism of drug action in vivo, provides guidance for the design of subsequent clinical studies, and recommends dosage for the final drug instructions, thereby ultimately improving the research and development efficiency and success rate of innovative drugs.
!["1" in the past year: The number of approved innovative drugs in Chinese medicines reached double digits for the first time[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)