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Cell

07 Virus. Cell. virus. Virus. 構造 DNA or RNA Protein 病毒的區分 依外觀區分 依遺傳物質區分. Types of genetic material in different virus. Double-stranded DNA Single-stranded DNA Double-stranded RNA Single-stranded RNA (+)sense RNA (-)non-sense RNA. Types of genetic material in different virus.

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Cell

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  1. 07 Virus Cell virus

  2. Virus • 構造 • DNA or RNA • Protein • 病毒的區分 • 依外觀區分 • 依遺傳物質區分

  3. Types of genetic material in different virus • Double-stranded DNA • Single-stranded DNA • Double-stranded RNA • Single-stranded RNA • (+)sense RNA • (-)non-sense RNA

  4. Types of genetic material in different virus

  5. Bacterial virus

  6. Bacteriophage lambda

  7. Influenza virus

  8. How are virus get into cells ?

  9. Baculovirus • 對特定寄主有極高的致病力與專一性，其宿主侷限於昆蟲及部分甲殼類動物 • 桿狀病毒包括 • 核多角病毒（nuclear polyhedrosis virus，NPV） • 顆粒體病毒（granulosis virus，GV）

  10. Baculovirus (續) • Double-stranded ,circular DNA • 80-200kb size • Accommodate an additional 100kb or more of foreign DNA • Two types of virions • Polyhedra –derived virion (PDV) • Budded virion (BV)

  11. Baculovirus (續)

  12. Baculovirus 的感染機制

  13. HIV

  14. HIV之葯物設計 • Zidovudine or azidothymidine (AZT) (also called ZDV) is a nucleoside analog reverse transcriptase inhibitor (NRTI), a type of antiretroviral drug. NRTIs:Zidovudine(AZT)Didanosine(ddI)Zalcitabine(ddC)Lamivudine(3TC)Stavudine(d4T)

  15. HIV之葯物設計 protease inhibitor: Saqunavir(invirase)Ritonavir(norvir)Indinavir(crixivan)

  16. 雞尾酒療法 • Combinations of antiretrovirals create multiple obstacles to HIV replication to keep the number of offspring low and reduce the possibility of a superior mutation.

  17. Food and Drug Administration（FDA，美國食品藥物檢驗局） • The drug advertising regulation contains two key requirements. Under most circumstances, a company may only advertise a drug for the specific indication or medical use for which it was approved. Also, an advertisement must contain "fair balance" between the benefits and risks of a drug.

  18. Clinical trial • Pre-clinical studies in vitro (test tube) and in vivo (animal) experiments preliminary efficacy, toxicity and pharmacokinetic information • Phase 0 • Phase I • Phase II • Phase III approved • Phase IV: Post Marketing Surveillance Trial

  19. Clinical trial • Pre-clinical studies • Phase 0 2006 Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body).

  20. Clinical trial • Pre-clinical studies • Phase 0 • Phase I Normally, a small (20-50) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. • Phase II • Phase III

  21. Clinical trial • Pre-clinical studies • Phase 0 • Phase I • Phase II Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. • Phase III

  22. Clinical trial • Pre-clinical studies • Phase 0 • Phase I • Phase II • Phase III Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run. approved • Phase IV: Post Marketing Surveillance Trial

  23. Polioviurs • Naked virion • (+)single-strand RNA • Producing an RNA replicase • Polyprotein

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