Lecture 2 Flashcards
The process through which (potential new medicines) are identified called ?
Drug discovery
Drug discovery involves a wide range of scientific disciplines , mention them :
1- biology
2- chemistry
3- pharmacology
The process of developing a new drug that effectively targets a specific weakness in a cell called ?
Drug development
Drug development involves pre-clinical development and testing, followed by _______ , to ______ .
1- trials in humans ,
2- determine the efficacy of the drug .
There are 3 disadvantages when development of new drugs , mention them ?
1- complex
2- costly
3- risky
The science and activities relating to the detection, assessment, understanding and prevention of adverse ——>(ضارة) effects or any other possible drug-related problems is ?
Pharmacovigilance
Give me the steps that we need to investigational drug succes :
• Discovery/Screening: 5000-10,000
• Enter Preclinical Testing: 250
• Enter Clinical Testing: 5
• Approved by Regulatory Bodies: 1
The process which implies the ability to predict the chemical structure of drug molecule on basis of (3-dimensional )structure of its receptor, employing at present suitable computer programs callled ?
Rational drug design
Many drugs in clinical use at present were developed in the rational way! (T/F)
F
(Only few drugs in clinical use at present were developed in this rational way) .
Most drugs were in the past developed through two method , mention them: 😊
1- random testing of chemicals
2- modified molecules of known drugs that are known to have some other pharmacological effect.
rational drug design with aid of computers will become more feasible , give me the reason
As more would become known about detailed structure of receptors.
Phase 1,2,3 consider as ?
Clinical testing
Give me the Steps of drug development :
A. In vitro studies
B. Animal testing
C. Clinical testing
D. Marketing
Pre-clinical Testing divided to three parts , mention them:
1- Determine pharmacokinetic parameters ( Absorption, distribution, metabolism…etc)
2- Determine pharmacodynamics (MOA)
3- Assessment of drug toxicity=safety
We can assessment of drug toxicity=safety be several studies , mention them:
1- Acute toxicity studies
(Determination of LD50; Margin of safety…etc)
2- Sub-acute and chronic toxicity studies
3- Repeated dose studies.
To correctly define the limiting toxicities of drugs and the therapeutic (((index))) comparing benefits and risks of a new drug is ?
Pre-clinical safety and toxicity testing .
Mention the parameters measured during pre-clinical phase
1- “no-adverse effect” dose
2- The minimum lethal
3-The median lethal dose (LD50).
The most essential part of the new drug development process is ?
Pre-clinical safety and toxicity testing
the smallest dose that is observed to kill any experimental animal is ?
The minimum lethal
the dose that kills approximately 50% of the animals is ?
The median lethal dose (LD50)
the maximum dose at which a specified toxic effect is not seen is ?
“no-adverse effect”dose
Example in slide 13 is ?
Very very very very important bro 🔥.
Mention the ethics of the use of drugs in humans ?
• Full detailed protocol has to be approved by the ethical committee, the institutional review board (IRB)
• All subjects should sign an informed agreement form
• All subjects should be insured for life and damage
Give me overview about Clinical trials’s phases :😊
A. Phase 1 – normal volunteers: safety, pharmacokinetics
B. Phase 2 – selected patients: therapeutic efficacy, dose range
C. Phase 3 – large populations of selected patients: therapeutic efficacy, safety in double blind studies
Give me two features of phase 1:
- Observes the effect of drug as a function of dosage
- Small number of ((healthy volunteers)) (25-50)
The Goal of phase 1 is ?
To find maximum tolerated dose .
Mention the condition in which patients with disease are used rather than normal volunteers :
(cancer, AIDS, i.e. drugs with significant toxicity) .
Phase I Detect safety & pharmacokinetics (T/!F)
T 😱
Give me the features of Phase II :
- Drug studied in patients with the target disease to determine efficacy
- Number of patients is 100-200
- Single-blind design with a placebo & positive control
- Detects broader range of toxicities
Now , give me the features of Phase III ? 😊
- Larger number of patients (e.g. Thousands)
- Conducted to ((minimize errors)) caused by placebo effects, variable cause of the disease etc
- Further study of safety & efficacy
FDA means?
Food and Drug administration
For what the FDA may permit extensive but controlled marketing of a new drug ((before phase 3 studies are completed )).
For serious diseases
FDA may permit controlled marketing even before phase 2 studies have been completed for ?
For life threatening disease.
What happens Once approval to market the drug has been obtained
phase 4 begins🔥
What is the function of phase 4 ?
monitoring the safety of the new drug under actual conditions of use in large numbers of patients
Phase 4 has no fixed duration (F/T) ?
T 😉
Some rare toxicities are unrevealed ? (T/F)
F
(Some rare toxicities are revealed (low incidence)
)
After all these clinical drug trials the drug is usually approved by national or International regulatory authorities and is licensed for General prescribing
Love u all 💕
Overdose midterm selected questions:
*In which drug discovery phase the acute toxicity level is determined?
a) Phase I
b) Phase II
c) Phase II
d) Preclinical testing
D
Vagus midterm selected questions:
- Regarding the drug development process, which one of the following combinations is correct?
Phase ꓲꓲꓲ+ involves crossover techniques
phase 0 “ or “ first in human “ trials were approved by the FDA in 2006. which one of the following statements is correct regarding these trials during drug development process?
these studies enable go / no go decisions to be based on relevant human models instead of relying on sometimes inconsistent animals’ data.
*During drug development process and before testing drugs on human, a full detailed protocol has to be approved by the ethical committee. which of the following is considered as an ethical committee?
Answer:
IRB (institutional review board)
