국가임상시험지원재단

● Translation of Non-Clinical Studies to Clinical Trials

Dong Hwan Kim(Konyang University)

Translational research or translational medicine is used for various circumstances such as benchside to bedside, early clinical to late clinical, bedside to community, community to benchside etc.
The safety factor is determined by comparing the pharmacokinetic exposure value at the effective dose with the toxicokinetic exposure value at the toxicity studies. The risk- Benefit analysis can be used to establish clinical entry and methods of clinical trials. In the case of drugs which are positive in genotoxicity, carcinogenicity and/or reproductive toxicity studies, human safety can be secured through risk assessment.
Non-clinical studies consist of pharmacology, pharmacokinetics and toxicology. Pharmacology includes primary pharmacodynamics, secondary pharmacodynamics and safety pharmacology. Pharmacokinetics involves absorption, distribution, metabolism and excretion. Toxicology consists of acute toxicity, repeated-dose toxicity, genotoxicity, carcinogenicity, reproductive toxicity, local tolerance and other toxicity studies.
For the clinical trials, these pharmacological, pharmacokinetic and toxicological studies should be comprehensively evaluated to establish the planning and direction of clinical trials, to estimate an initial safe starting dose and dose range for the human trials and to identify parameters for clinical monitoring for potential adverse effects.
The safety factor is determined by comparing the pharmacokinetic exposure value at the effective dose with the toxicokinetic exposure value at the toxicity studies. The risk- Benefit analysis can be used to establish clinical entry and methods of clinical trials. In the case of drugs which are positive in genotoxicity, carcinogenicity and/or reproductive toxicity studies, human safety can be secured through risk assessment.?

● Accelerating Clinical Development Using Cutting Edge Preclinical Technologies and E-data Submission

Takayuki Anzai(Showa University School of Medicine)

Modern new drug development demands an integrative approach, using many different screening tests during nonclinical phase, once a target for discovery has been chosen, a pharmaceutical company works on the efficacy profiling using nonclinical research models.
In addition to this, the latest US FDA’s requirement for electronic data submission will be a key for cutting time to the market. Speaker also introduces how you can shorten the time period for IND and NDA process.
In addition to this, the latest US FDA’s requirement for electronic data submission will be a key for cutting time to the market. Speaker also introduces how you can shorten the time period for IND and NDA process.?

2. Takayuki Anzai(Showa University School of Medicine) 

상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

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