美迪西展位#43

第46屆韓國(guó)非臨床試驗(yàn)研討會(huì) (The Korean Society of Nonclinical Study, KSNS) 將于2024年10月17-18日在韓國(guó)慶尚南道舉行。本次大會(huì)由韓國(guó)非臨床試驗(yàn)研究協(xié)會(huì)（KSNS）組織，是韓國(guó)最負(fù)盛名和最具影響力的非臨床研究會(huì)議之一。屆時(shí)來自生物醫(yī)藥技術(shù)領(lǐng)域研發(fā)公司的領(lǐng)導(dǎo)者和決策者，及眾多非臨床研究專家們都將參加此次活動(dòng)。TFM of Medicilon Chuansha Site鄒漢軍博士DABT將帶領(lǐng)美迪西美國(guó)團(tuán)隊(duì)出席此次大會(huì)，我們?cè)谡刮?43，期待與您的交流！

時(shí)間 | October 17-18, 2024
地點(diǎn) | Gyeongju, South Gyeongsang Province
美迪西展位  | 43，不見不散！

作為國(guó)內(nèi)較早為客戶提供臨床前動(dòng)物實(shí)驗(yàn)的CRO公司之一，美迪西具備全面的臨床前研究服務(wù)能力，能夠提供系統(tǒng)的體內(nèi)藥效學(xué)和GLP條件下的藥代動(dòng)力學(xué)、安全性評(píng)價(jià)研究服務(wù)。目前美迪西已擁有多種穩(wěn)定的藥效評(píng)價(jià)模型，可對(duì)細(xì)胞毒及靶向類小分子、單抗及雙特異抗體等大分子藥物、ADC、CAR-T/CAR-NK細(xì)胞治療抗腫瘤新藥提供全面系統(tǒng)的評(píng)價(jià)。美迪西對(duì)大量化學(xué)藥物和生物藥物建立了系統(tǒng)分析方法和體內(nèi)外評(píng)價(jià)方法，包括小分子和大分子生物分析平臺(tái)、免疫分析工作站及放射性同位素藥代動(dòng)力學(xué)研究平臺(tái)等，支持早期篩選、成藥性評(píng)價(jià)和IND申報(bào)等。美迪西擁有經(jīng)中國(guó)NMPA認(rèn)證的GLP資質(zhì)，且通過了美國(guó)FDA的GLP現(xiàn)場(chǎng)檢查，具備符合國(guó)際標(biāo)準(zhǔn)的GLP體系，并且獲得AAALAC認(rèn)證，實(shí)驗(yàn)動(dòng)物管理質(zhì)量標(biāo)準(zhǔn)獲得國(guó)際認(rèn)可。至2024年6月底，美迪西已為全球超2000家客戶提供藥物研發(fā)服務(wù)，參與研發(fā)完成的新藥及仿制藥項(xiàng)目已有490件IND獲批臨床，與國(guó)內(nèi)外優(yōu)質(zhì)客戶共同成長(zhǎng)。

KSNS現(xiàn)場(chǎng)美迪西專家

鄒漢軍博士 TFM of Medicilon Chuansha Site

Dr. Hanjun Zou is currently the Testing Facility Management for Medicilon Chuansha site in Shanghai. Dr. Zou joined Medicilon in March 2023 as Senior Director in which he led the team or as the study director to be responsible for the overall planning and implementation of the nonclinical study programs, including but not limited to the IND/NDA package design, selection of species, dose determination, protocol design, results interpretation, report drafting and communication with regulatory agencies. The type of drugs he supported included small molecule chemicals, peptide, fusion protein, oligonucleotide, single/bispecific antibodies, ADC, CGT product etc. Before joining Medicilon, Dr. Zou has more than 16 years of experience in toxicity and preclinical safety assessment with most career working in multinational companies. Dr. Zou is also a certified toxicologist (DCST, ERT & DABT) in China, Europe and the United States.

美迪西非臨床研究服務(wù)

Medicilon's state-of-the-art preclinical facilities hold full AAALAC accreditation. With advanced platforms and experienced scientists, Medicilon guarantees the utmost professionalism in drug efficacy and safety assessments services, adhering to global regulatory standards. Offering services from stand-alone preclinical studies to comprehensive IND-enabling packages, Medicilon provides flexible solutions to efficiently support biotech and pharmaceutical clients in reaching their developmental milestones. Medicilon's Preclinical Research Division services include the following for small molecules, biologics and medicinal herbs: Pharmacology, Pharmacodynamics, ADME, DMPK, Bioanalysis, Drug Safety Evaluation. Medicilon maintains a large in-house library of animal disease models to meet the research demands in different therapeutic areas.  Medicilon can also assist clients in the preparation of a preclinical safety evaluation package.

Pharmacology 

?Tumor Animal Models (400+) 
?Non-tumor Animal Models (270+)

DMPK & Bioanalysis

?In Vitro ADMET 
?In Vivo PK & Tox

Preclinical Safety Assessment (GLP & non-GLP) 

?Single and repeated-dose toxicity studies
 ?Reproductive/developmental and juvenile toxicity studies
 ?Genotoxicity studies
 ?Toxicokinetic studies
 ?Safety pharmacology research
 ?Immunogenicity studies
 ?Local tolerance studies
 ?Carcinogenicity studies

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