BPS 2110 - Final Exam Questions With
Correct Answers
What |is |the |goal |of |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Dose |Finding
How |many |patients |are |involved |in |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Small |
number |(<100)
What |type |of |patients |are |involved |in |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-
Healthy |volunteers
What |is |the |average |time |taken |for |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-< |1 |year
What |is |the |drug |failure |rate |of |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-30%
What |is |the |goal |of |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Safety |and |efficacy
How |many |patients |are |involved |in |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Medium
|number |(~200-300)
What |type |of |patients |are |involved |in |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-
Patients
What |is |the |average |time |taken |for |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~1 |year
What |is |the |drug |failure |rate |of |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~70%
,What |is |the |goal |of |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Find |rare |side |effects
How |many |patients |are |involved |in |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Large |
number |(~1000)
What |is |the |average |time |taken |for |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~1 |year
What |type |of |patients |are |involved |in |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-
Patients
What |is |the |drug |failure |rate |of |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~70%
What |are |the |two |general |types |of |large |pharmaceutical |companies? |- |CORRECT |ANSWER✔✔-
Ethical |pharmaceutical |companies |and |generic |pharmaceutical |companies
What |are |ethical |pharmaceutical |companies? |- |CORRECT |ANSWER✔✔-Companies |that |invest |
heavily |in |research. |They |discover |and |develop |new |molecular |entities.
What |are |generic |pharmaceutical |companies? |- |CORRECT |ANSWER✔✔-They |focus |on |
breaking/ |adapting |patents |and |manufacturing |methods |and |formulation.
What |are |drug |products? |- |CORRECT |ANSWER✔✔-Licensed |products |that |contain |the |same |
molecular |entities |in |different |forms.
What |are |molecular |entities? |- |CORRECT |ANSWER✔✔-The |active |ingredient |in |drugs.
,What |is |a |drug |candidate? |- |CORRECT |ANSWER✔✔-The |structure |and |all |of |the |important |
information |regarding |the |chemical |compound.
What |is |an |IND? |- |CORRECT |ANSWER✔✔-Investigational |New |Drug. |An |application |made |to |
the |FDA |to |enter |development.
What |is |an |NDA? |- |CORRECT |ANSWER✔✔-New |Drug |Application. |An |application |made |to |the |
FDA |to |the |enter |the |market.
What |is |an |ANDA? |- |CORRECT |ANSWER✔✔-Abbreviated |New |Drug |Application. |An |application |
made |to |the |FDA |to |enter |the |market |for |generic |drugs.
Why |do |drug |companies |prefer |to |treat |chronic |conditions |rather |than |acute |ones? |- |CORRECT
|ANSWER✔✔-They |are |targeting |the |market |rather |than |the |disease. |With |chronic |conditions, |
the |customer |will |need |to |purchase |the |drug |for |much |longer |than |acute |conditions. |This |
brings |more |money |to |the |drug |company.
What |are |the |three |most |common |methods |of |lead |identification |in |the |pharmaceutical |
industry? |- |CORRECT |ANSWER✔✔--High |throughput |screening.
-Rational |drug |design.
-Natural |products
What |characteristics |make |a |good |lead |compound? |- |CORRECT |ANSWER✔✔--Proven |biological
|activity. |
-Some |specificity
-"Drug-like" |properties
-Patent |opportunity
, What |are |two |key |difficulties |associated |with |natural |products |in |terms |of |drug |development?
|- |CORRECT |ANSWER✔✔--Chemical |synthesis |of |related |compounds |is |difficult. |
-Limited |to |chemical |modifications |of |the |natural |product.
Describe |how |drug |companies |perform |safety |testing |during |drug |development. |- |CORRECT |
ANSWER✔✔--In-vitro |testing, |using |biochemical |assays, |and |looking |for |a |"clean" |profile.
-Animal |testing
List |4 |different |types |of |excipients |and |briefly |explain |their |importance |for |formulation. |- |
CORRECT |ANSWER✔✔--Preservatives: |Prevent |mold |and |bacterial |growth.
-Disintegrants: |"Blows" |the |pill |apart |in |the |stomach. |
-Binders: |Hold |ingredients |together. |
-Stabilizers: |Protect |from |chemical |degradation |due |to |oxygen.
List |4 |different |types |of |formulation |and |provide |a |key |advantage |and |disadvantage |of |each. |- |
CORRECT |ANSWER✔✔--Pills: |Most |convenient, |does |not |by-pass |the |liver. |
-Suppositories: |Least |convenient, |by-passes |the |lier. |
-Capsules: |Convenient, |does |not |by-pass |the |liver.
-Topical |cream: |Not |convenient, |by-passes |the |liver.
What |are |the |key |parts |of |the |Nuremburg |code |for |research |on |humans? |Why |is |it |important |
to |adopt |and |follow |such |a |code? |- |CORRECT |ANSWER✔✔-Key |parts:
-Voluntary |participation
-Informed |consent
-No |suffering
-Previous |animal |tests. |
This |keeps |humans |safe |and |research |ethical.
Correct Answers
What |is |the |goal |of |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Dose |Finding
How |many |patients |are |involved |in |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Small |
number |(<100)
What |type |of |patients |are |involved |in |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-
Healthy |volunteers
What |is |the |average |time |taken |for |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-< |1 |year
What |is |the |drug |failure |rate |of |Phase |1 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-30%
What |is |the |goal |of |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Safety |and |efficacy
How |many |patients |are |involved |in |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Medium
|number |(~200-300)
What |type |of |patients |are |involved |in |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-
Patients
What |is |the |average |time |taken |for |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~1 |year
What |is |the |drug |failure |rate |of |Phase |2 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~70%
,What |is |the |goal |of |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Find |rare |side |effects
How |many |patients |are |involved |in |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-Large |
number |(~1000)
What |is |the |average |time |taken |for |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~1 |year
What |type |of |patients |are |involved |in |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-
Patients
What |is |the |drug |failure |rate |of |Phase |3 |of |Clinical |Trials? |- |CORRECT |ANSWER✔✔-~70%
What |are |the |two |general |types |of |large |pharmaceutical |companies? |- |CORRECT |ANSWER✔✔-
Ethical |pharmaceutical |companies |and |generic |pharmaceutical |companies
What |are |ethical |pharmaceutical |companies? |- |CORRECT |ANSWER✔✔-Companies |that |invest |
heavily |in |research. |They |discover |and |develop |new |molecular |entities.
What |are |generic |pharmaceutical |companies? |- |CORRECT |ANSWER✔✔-They |focus |on |
breaking/ |adapting |patents |and |manufacturing |methods |and |formulation.
What |are |drug |products? |- |CORRECT |ANSWER✔✔-Licensed |products |that |contain |the |same |
molecular |entities |in |different |forms.
What |are |molecular |entities? |- |CORRECT |ANSWER✔✔-The |active |ingredient |in |drugs.
,What |is |a |drug |candidate? |- |CORRECT |ANSWER✔✔-The |structure |and |all |of |the |important |
information |regarding |the |chemical |compound.
What |is |an |IND? |- |CORRECT |ANSWER✔✔-Investigational |New |Drug. |An |application |made |to |
the |FDA |to |enter |development.
What |is |an |NDA? |- |CORRECT |ANSWER✔✔-New |Drug |Application. |An |application |made |to |the |
FDA |to |the |enter |the |market.
What |is |an |ANDA? |- |CORRECT |ANSWER✔✔-Abbreviated |New |Drug |Application. |An |application |
made |to |the |FDA |to |enter |the |market |for |generic |drugs.
Why |do |drug |companies |prefer |to |treat |chronic |conditions |rather |than |acute |ones? |- |CORRECT
|ANSWER✔✔-They |are |targeting |the |market |rather |than |the |disease. |With |chronic |conditions, |
the |customer |will |need |to |purchase |the |drug |for |much |longer |than |acute |conditions. |This |
brings |more |money |to |the |drug |company.
What |are |the |three |most |common |methods |of |lead |identification |in |the |pharmaceutical |
industry? |- |CORRECT |ANSWER✔✔--High |throughput |screening.
-Rational |drug |design.
-Natural |products
What |characteristics |make |a |good |lead |compound? |- |CORRECT |ANSWER✔✔--Proven |biological
|activity. |
-Some |specificity
-"Drug-like" |properties
-Patent |opportunity
, What |are |two |key |difficulties |associated |with |natural |products |in |terms |of |drug |development?
|- |CORRECT |ANSWER✔✔--Chemical |synthesis |of |related |compounds |is |difficult. |
-Limited |to |chemical |modifications |of |the |natural |product.
Describe |how |drug |companies |perform |safety |testing |during |drug |development. |- |CORRECT |
ANSWER✔✔--In-vitro |testing, |using |biochemical |assays, |and |looking |for |a |"clean" |profile.
-Animal |testing
List |4 |different |types |of |excipients |and |briefly |explain |their |importance |for |formulation. |- |
CORRECT |ANSWER✔✔--Preservatives: |Prevent |mold |and |bacterial |growth.
-Disintegrants: |"Blows" |the |pill |apart |in |the |stomach. |
-Binders: |Hold |ingredients |together. |
-Stabilizers: |Protect |from |chemical |degradation |due |to |oxygen.
List |4 |different |types |of |formulation |and |provide |a |key |advantage |and |disadvantage |of |each. |- |
CORRECT |ANSWER✔✔--Pills: |Most |convenient, |does |not |by-pass |the |liver. |
-Suppositories: |Least |convenient, |by-passes |the |lier. |
-Capsules: |Convenient, |does |not |by-pass |the |liver.
-Topical |cream: |Not |convenient, |by-passes |the |liver.
What |are |the |key |parts |of |the |Nuremburg |code |for |research |on |humans? |Why |is |it |important |
to |adopt |and |follow |such |a |code? |- |CORRECT |ANSWER✔✔-Key |parts:
-Voluntary |participation
-Informed |consent
-No |suffering
-Previous |animal |tests. |
This |keeps |humans |safe |and |research |ethical.
