Shared Flashcard Set

Details

Ethical Aspects of Drug R&D Medical Drug Use
Ethics Final
14
Science
Undergraduate 1
12/13/2015

Additional Science Flashcards

 


 

Cards

Term




Who is interested? 

Definition
  • Pharmaceutical companies
  • physicians 
  • patent holders
  • insurance companies
  • politicans
  • profits
  • hospitals 
  • society
  • scientists
Term

 

 

Who are the players?

Definition
  • pharmaceutical industry
  • patients
  • physicans
  • health insurance
  • politicians 
  • society 
Term
What do the players want?
Definition
  1. Effective treatment ALL 
  2. Safe treatment ALL
  3. Low risk ALL
  4. Cheap Treatment ALL EXCEPT MANUFACTURERS
  5. HIGH PROFIT 
Term

 

 

 

8 Steps of Drug Review

Definition
  1. Preclinical (Animal Testing)
  2. IND- Investigational New Drug application: outlines what the sponder of a new drug proposes for human testing in clincial trails 
  3. Phase 1 studies 
  4. Phase 2 Studies
  5. Phase 3 Studies 
  6. NDA- Submission of new drug application: the formal step asking the FDA to consider a drug for marketing approval 
  7. FDA reviewers will approve the application or find it either approvable or "not apporvable"
  8. Phase 4 studies 
Term

 

 

 

Clinlical Drug Development Phase 

Definition

1. Preclinical Data

2. Investigational New Drug Filing

3. IND approval

4. Phase I

5. Phase II

6. Phase III

7. New Drug Application Filed

8. NDA Approval

9. Marketing Permission

10. Phase IV 

Term

 

 

 

What is the aprox. average of months from initial synthesis approval of New Drug Application? (NDA)

Definition

 

 

 

100 Months! 

Term

 

 

 

What is the next step after one's extensive stages are successful? 

Definition

 

the sponsor then provides this data to the FDA--> requests approval to begin testing in humans --> this is called an IND( Invenstigational New Drug) 

 

Approved by the FDA? then testing in humans begins 

Term

 

 

What are the major areas of Preclinical Studies? 

 

Definition
  • Pharmacodynamic studies in vivo in animals, in vitro prepparpation 
  • absorption, distribution, elimination studies (pharmacokinetics) 
  • acute, sub acute, chronic toxicity studies ( toxicity profile) 
  • therapeutic index (saftey & efficacy evaluation) 
Term

 

 

PHASES OF CLINICAL TRAILS 

Phase 0 

Definition

- Study/microdosing

- from work bench to humans, is the agent hitting the target? 

- Objective: to obtain preliminary pharmacokinetic data 


- study of new drug in microdoses to derive PK info in human before undertaking phase I studies is called PHASE O 

 

Term

 

 

 

What is a microdose?

 

 

 

Definition

 

 

less than 1/100 of the dose of a test substance calculated to produce pharmacological effect with a max dose less than or equal to 100 micograms 

Term

 

 

 

What is Priclinical Data?

 

 

 

Definition

 

 

 

 

Subacute toxicity sutyd in ones species by two routes of administration 

Term

 

 

 

PHASES OF CLINICAL TRAITS

Phase 1 

Definition

- First stage of testing in human subjects

- deciding on a dose, considering DLT and MTD 

- Deisgned to assess the saftey, tolerability, PK, and PD of a drug 

- 20-25 healthy volunteers

- Patients: Anticancer drugs, AIDS therapy 

- Duration: 6-12 months

- no blinding/ open labelled 

Term

 

 

PHASES OF CLINICAL TRAILS

Phase II 

Definition

- Therapeutic Exploratory Trial 

- Drug activity, saftey, and feasibility evaluation 

- 20-300 subjects

- to confim effectiveness, monitor side effects, and further evaluate saftey 

- first in patients ( who have the disease that the drug is expected to treat) 

- Duration: 6 months to several years 

Term

 

Whats are the objectives of Phase II? 

Definition

Primary Objective: Efficacy in patients

 

Secondary Objective: Saftey  issues 

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