Cell

virus

07 Virus07 Virus

VirusVirus

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 virusTypes of genetic material in different virus

Double-stranded DNA

Single-stranded DNA

Double-stranded RNA

Single-stranded RNA(+)sense RNA

(-)non-sense RNA

Bacterial virusBacterial virus

Bacteriophage lambdaBacteriophage lambda

Influenza virusInfluenza virus

How are virus get into cells ?How are virus get into cells ?

BaculovirusBaculovirus

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 ）

Baculovirus ( 續 )Baculovirus ( 續 )

Double-stranded ,circular DNA

80-200kb size

Accommodate an additional 100kb or more of foreign DNA

Two types of virionsPolyhedra –derived virion (PDV)

Budded virion (BV)

Baculovirus ( 續 )Baculovirus ( 續 )

Baculovirus 的感染機制Baculovirus 的感染機制

HIVHIV

HIV 之葯物設計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)

protease inhibitor:

HIV 之葯物設計HIV 之葯物設計

Saqunavir(invirase)

Ritonavir(norvir)

Indinavir(crixivan)

雞尾酒療法 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.

Food and Drug Administration（ FDA ，美國食品藥物檢驗局） 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.

Clinical trialClinical trial

Pre-clinical studies in vitro (test tube) and in vivo (animal) experiments preliminary efficacy, toxicity and pharmacokinetic information

Phase 0Phase I Phase II Phase III

approved Phase IV: Post Marketing Surveillance Trial

Clinical trialClinical 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).

Clinical trialClinical trial

Pre-clinical studiesPhase 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

Clinical trialClinical trial

Pre-clinical studiesPhase 0Phase 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

Clinical trialClinical trialPre-clinical studiesPhase 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.

approvedPhase IV: Post Marketing Surveillance Trial

PolioviursPolioviurs

Naked virion

(+)single-strand RNA

Producing an RNA replicase

Polyprotein