Day 1 :
- Pharmaceutical Sciences
Location: London,UK
Chair
Jun Guo
Shanghai Institute for Biomedical and Pharmaceutical Technologies, China
Session Introduction
Jun Guo
Shanghai Institute for Biomedical and Pharmaceutical Technologies, China
Title: Exploring the relevance and considerations of implementing alternative approaches to the assessment of reproductive and developmental toxicity of pharmaceuticals under ICH S5(R3)
Time : 10:40-11:00
Biography:
Jun Guo, MD, PhD is Director and FM of the National Evaluation Centre for Toxicology of Fertility Regulating Drug at the Shanghai Institute for Biomedical and Pharmaceutical Technologies. Her extensive expertise focuses on pharmacological and toxicological research as well as non-clinical safety evaluation of drugs. Present she is working as a Council Member of the Chinese Society of Toxicology (CSOT). She is also the Executive Member and Secretary General of the Special Committee on Reproductive Toxicology within the CSOT. With over a decade of leadership experience, she has led and contributed to numerous national, provincial and ministerial research initiatives. Her contributions extend to more than 30 published papers and 5 books, either as sole editor or co-editor, reinforcing his prominent position in the field.
Abstract:
The 3Rs principle (Replace, Reduce and Refine) and the ICH S5 (R3) guideline have globally advanced alternative methods for reproductive and developmental toxicity assessment. These developments bring about stringent requirements and challenges. Reproductive and developmental toxicity assessment is complex, and current alternatives don't fully replicate in vivo drug actions, impacting sexual maturation, fertilization, gametogenesis, syncytial development, postnatal maturation and sexual functionality.
ICH S5 (R3) promotes reducing animal use without compromising risk assessment quality, emphasizing justification for including alternative tests in the strategy, adherence to Good Laboratory Practice (GLP), and evaluation of drug metabolite effects following ICH M3 guidelines. The guideline doesn't prescribe specific methods but demands rigorous method validation and lists 29 reference compounds causing maternal embryofetal lethality (MEFL) in non-clinical or human studies with minimal maternal toxicity. Test endpoints should align with objectives and predictive capabilities.
Zuyue Sun
Shanghai Institute for Biomedical and Pharmaceutical Technologies, China
Title: Advances in prostate pharmacology and toxicology and cutting-edge developments in drug research
Biography:
Zuyue Sun, MD, PhD, a distinguished research fellow and PhD supervisor at Fudan University, serves as Chief Scientist of the Shanghai Research Institute of Biomedical Technology (SRIBT). He has been awarded the title of a national excellent scientific and technological worker for his remarkable contributions to science, and he also enjoys the privilege of receiving the State Council's Special Allowance. In addition, He serves as the Honorary Chairman of the Reproductive Toxicology Committee within the Chinese Society of Toxicology. He is further acknowledged for his leadership as the Editor-in-Chief of esteemed monographs, Prostate Pharmacology and Prostate Toxicology. His extensive qualifications and influential positions highlight his important contributions to the field of toxicology.
Abstract:
Prostate pharmacology is a specialized area that explores the complex interrelationship between pharmaceuticals and the prostate gland. This discipline includes drug mechanisms, pharmacokinetics, and urofluid dynamics. These components collectively illuminate drug interactions, principles, drug behavior within the body (absorption, distribution, biotransformation, excretion), and how drug effects evolve over time. Furthermore, they encompass processes such as urine flow, urinary flow rate, and bladder pressure.
Conversely, prostate toxicology investigates the effect of external factors, consisting of chemicals, physical elements and biological agents, on the prostate gland. This scientific field examines the severity and frequency of damage, as well as the generation of toxic reactions and the mechanisms that cause toxicity. In addition, it entails both qualitative and quantitative evaluations of the prostate's response to toxic agents.
Testosterone is enzymatically converted into dihydrotestosterone by the action of 5α-reductase. Dihydrotestosterone, exerts a direct stimulatory effect on the proliferation of prostate epithelial cells. This proliferative response results in the enlargement of the prostate gland, which subsequently leads to symptoms such as increased urinary frequency, urgency and retention.