h******e
发帖数: 1791 | |
E***n
发帖数: 308 | 2 pk and pd, even efficacy.
【在 h******e 的大作中提到】
: 学习。
|
h*******o
发帖数: 4884 | 3 that's wrong
Phase I is all about toxicity, or more specifically to find the maximal
tolerable dose with some Pk, Pd data collection. Usually no efficacy is
tested in phase I unless it's something like anti-cancer drugs.
Phase II is more about pk, pd and some efficacy.
Phase III is the large scale efficacy test.
Phase IV is about post market pharmacovigilence
【在 E***n 的大作中提到】
: pk and pd, even efficacy.
|
t**n
发帖数: 4365 | 4 你的归类对于general medicine是没错，不过楼主问的是oncology的药啊
【在 h*******o 的大作中提到】
: that's wrong
: Phase I is all about toxicity, or more specifically to find the maximal
: tolerable dose with some Pk, Pd data collection. Usually no efficacy is
: tested in phase I unless it's something like anti-cancer drugs.
: Phase II is more about pk, pd and some efficacy.
: Phase III is the large scale efficacy test.
: Phase IV is about post market pharmacovigilence
|
E***n
发帖数: 308 | 5 cancer drug can skip phase II to go directly in phase III. Most of time sick
patients are enrolled instead of health subjects.
【在 h*******o 的大作中提到】
: that's wrong
: Phase I is all about toxicity, or more specifically to find the maximal
: tolerable dose with some Pk, Pd data collection. Usually no efficacy is
: tested in phase I unless it's something like anti-cancer drugs.
: Phase II is more about pk, pd and some efficacy.
: Phase III is the large scale efficacy test.
: Phase IV is about post market pharmacovigilence
|
h*******o
发帖数: 4884 | 6 The reason why canti-cancer trials recruit patients rather than healthy
subjects is that these compounds usually have severe side effect. It will be
hard to get IRB approval to enroll healthy subject. The other reason is
because cancer is life threatening disease. Directly enroll patients into
phase I may offer some marginal benefits.
That being said, oncology phase I still aims to identify MTD( Maximal
tolerable dose), and if lucky some PK/PD parameters. Generally, nobody aims
efficacy in phase
【在 E***n 的大作中提到】
: cancer drug can skip phase II to go directly in phase III. Most of time sick
: patients are enrolled instead of health subjects.
|
E***n
发帖数: 308 | 7 points taken.
be
aims
【在 h*******o 的大作中提到】
: The reason why canti-cancer trials recruit patients rather than healthy
: subjects is that these compounds usually have severe side effect. It will be
: hard to get IRB approval to enroll healthy subject. The other reason is
: because cancer is life threatening disease. Directly enroll patients into
: phase I may offer some marginal benefits.
: That being said, oncology phase I still aims to identify MTD( Maximal
: tolerable dose), and if lucky some PK/PD parameters. Generally, nobody aims
: efficacy in phase
|
t**n
发帖数: 4365 | 8 受教了。
be
aims
【在 h*******o 的大作中提到】
: The reason why canti-cancer trials recruit patients rather than healthy
: subjects is that these compounds usually have severe side effect. It will be
: hard to get IRB approval to enroll healthy subject. The other reason is
: because cancer is life threatening disease. Directly enroll patients into
: phase I may offer some marginal benefits.
: That being said, oncology phase I still aims to identify MTD( Maximal
: tolerable dose), and if lucky some PK/PD parameters. Generally, nobody aims
: efficacy in phase
|
a******8
发帖数: 4 | |
g**p
发帖数: 32 | 10 In this day and age, PK and PD are almost always looked at in Phase 1 onc
trials. Efficacy is also important in Phase 1, although usually a secondary
endpoint. An overwhelmingly positive efficacy signal (most often in an
expansion cohort) can often trigger the decision to move directly to pivotal
Phase 3 trial.
be
aims at
which
【在 h*******o 的大作中提到】
: The reason why canti-cancer trials recruit patients rather than healthy
: subjects is that these compounds usually have severe side effect. It will be
: hard to get IRB approval to enroll healthy subject. The other reason is
: because cancer is life threatening disease. Directly enroll patients into
: phase I may offer some marginal benefits.
: That being said, oncology phase I still aims to identify MTD( Maximal
: tolerable dose), and if lucky some PK/PD parameters. Generally, nobody aims
: efficacy in phase
|
