Transcript Ch 09

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
Bacterial virus
Bacteriophage lambda
Influenza virus
How are virus get into cells ?
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）
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)
Baculovirus (續)
Baculovirus 的感染機制
HIV
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)
HIV之葯物設計
protease inhibitor:
Saqunavir(invirase)
Ritonavir(norvir)
Indinavir(crixivan)
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）
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 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
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).
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
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
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
Polioviurs
Naked virion
(+)single-strand RNA
Producing an RNA replicase
Polyprotein