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Prospek Riset Toksisitas dalam Menunjang Pengawasan Obat dan Makanan

Prospek Riset Toksisitas dalam Menunjang Pengawasan Obat dan Makanan. Frans D. Suyatna Departemen Farmakologi dan Terapeutik FKUI. Toxicology. All subtances are poisons, there is none which is not poison (Paracelsus) The right dose and timing differentiates a poison from a remedy.

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Prospek Riset Toksisitas dalam Menunjang Pengawasan Obat dan Makanan

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  1. ProspekRisetToksisitasdalamMenunjangPengawasanObatdanMakanan Frans D. Suyatna DepartemenFarmakologidanTerapeutik FKUI

  2. Toxicology All subtances are poisons, there is none which is not poison (Paracelsus) The right dose and timing differentiates a poison from a remedy

  3. RISK = HAZARD X EXPOSURE Risk : The probability of harm Hazard : The potential to harm Exposure : The contact of a chemical, physical, or biological substance with the boundary of an organism

  4. RISK ASSESSMENT Hazard identification Dose – response Exposure assessment (without exposure no risk) Risk characterisation

  5. RISK MANAGEMENT The process of identifying, evaluating, selecting and implementing actions to reduce risk to human health and to ecosystems

  6. Risk Assessment / Risk Management Technical Dose-response Assessment Socieconomic Hazard Identification Dose-response Management Regulatory Decission Political Exposure Assessment Other

  7. SumberinformasiuntukBadanRegulasi • Epidemiology • Human Studies • Animal toxicology

  8. 1. RisetToksikologi • IntegrasidanresponsifuntukRegulatori • Independen & berkualitas

  9. 2. Research Characteristic • - Open - Transparent - Peer-review research planning 2) Competitive 3) Independent 4) Rigorous peer review research lab

  10. Riset yang berkualitas • Penyusunanstrategirisetdanrencanamengenaimasalah yang menyebabkanresikotinggiuntukkesehatandanlingkungan • Evaluasirencanadanstrategisecaraperiodikdanmenyesuaikannyadenganhasilriset yang diperolehdenganmengubahprioritasatauadanyamasalahbaru • Adanyaaktivitas peer review untukrencanadanstrategi • BekerjasamadenganBadan lain

  11. AktivitasRiset • Problem-driven research (untukmemecahkanmasalahlingkunganberisikotinggidantidakjelas) • Core research (memperbaikidasarilmiahuntukpemahamandanproteksikesehatandanlingkungan)

  12. Fungsirisettoksikologi • DitentukanolehinformasiilmiahdankeselarasandenganBadanRegulasi • Sainstidakmengaturstrategidan policy BadanRegulasi, tetapibersamadenganfaktor lain yang berkaitanmemberikaninformasidanmenunjangkebijakanBadanRegulasi

  13. EPA • Computational Toxicology Research • Drinking water research • Ecosystem Service Research • Global change • Human health • Human Health Risk Assessment • Land research • Nanotechnology • Pesticide & Toxic Substances Research • Water Quality

  14. NCTR Research • Annual Report • Centers of Excellence • Research Divisions • Research Focus Area • Research Publication • NCTR Strategic Plan

  15. Deskripsi • MelakukanrisetsesuaimisiBadanRegulasi, peer-reviewed untukkebijaksanaan regulatory danmengurangirisikountukmelindungidanmeningkatkandankesehatan • Meliputirisetdasardanterapanuntukmemahamimekanismetoksisitas, menilaiobatbarudanmembuatpedomanuntukpengembangan standard Badan Regulatory dan product risk surveillance

  16. RancanganStrategik Mengembangkan Melakukanvalidasimetodebaru Melaksanakanrisetinovatif 1. Untukmeningkatkanprosesregulasi yang efisiendanpengambilankeputusan Untuk design study dilakukan peer-review dengan expert dariakademia, industridll 2. Termasuk media cetak, publikasi, televisi 3. Keamanan premarket danpreklinikmeliputimakanan, kosmetik, suplemen, obat untukmanusiadanhewandanalatkesehatan Mengembangkan material, metodedanproseskomunikasibarudaninovatif yang digunakansecara internal daneksternaluntukmasyarakat Memperkuatdanmemperbaharuimanajemenadministrasiuntukmenunjang Tujuan, Badan Regulatory Ketersediaandana, pakardanjaringan

  17. Toxicology test • Existing chemical (EPA : Toxic Substance Control Act Chemical Substance Inventory)

  18. 2. PermintaandariBadan lain

  19. Test types • Health Effects Testing: general toxicity, exposure assessment, specific organ / tissue toxicity, neurotoxicity and / or metabolism • Environmental Effects Testing: aquatic and terrestrial toxicity testing • Chemical Fate Testing: determination of physical & chemical properties, transport processes etc

  20. Pesticides • Household (insecticides, rodenticides) • Agriculture (herbicides, rodenticides)

  21. Toxicology test New Drug Application FDA Guidelines • Drug identification • Animal (mouse, rat, hamster, other rodents, rabbit, dog, monkey, other non rodent mammals) • Route & mode of administration. Oral-IV-IM-IP-SQ-inhalation-topical , other in vivo, in vitro • Dose Untreated control, vehicle control, low dose, middle dose, high dose, positive / comparative control • Order of Presentation of Studies Pharmacologic Studies Acute Toxicity Studies Multidose Toxicity Studies (subchronic / chronic, carcinogenicity) Special Toxicity Studies (Irritation, Sensitization, Antigenicity, etc) Reproduction Studies Mutagenicity Studies ADME Studies

  22. Investigational New Drug Preclinical Acute : 2 species Subchronic : 2 species Chronic : 2 species Carcinogenicity : 2 rodents Reproductive Toxicity

  23. Segment I : rats II : rats, rabbits III : rats Specialty studies (mutagenicity, antigenicity, dermal/ocular irritation, mucosal irritation, etc) Duration of animal studies depends on duration of clinical usage

  24. Segment I: Reproductive and Fertility Studies in rats • All reproductive parameters from exposure of gametes to F2 generation • Dosing: males and females before mating: females through end of lactation • Segment II: Teratology • Pregnant females dosed during period of organogenesis • Rats: gestational days 6-15 of 21 • Rabbits: gestational days 6-18 of 31 • Evaluate teratogenic effects on soft tissue and skeletal tissues of fetus

  25. 3. Segment III: Peri-postnatal • Pregnant females dosed on gestational days 15 through postpartum day 21 • Examines late gestational, parturition and lactation effects

  26. GRAS • Medical Devices

  27. New Drug Application Toxicology Testing Investigational New Drug Toxicology Handbook / Guidelines Method Validation Core Research

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