Who is interested? 

Who are the players?

• pharmaceutical industry
• patients
• physicans
• health insurance
• politicians 
• society 

1. Effective treatment ALL 
2. Safe treatment ALL
3. Low risk ALL
4. Cheap Treatment ALL EXCEPT MANUFACTURERS
5. HIGH PROFIT 

8 Steps of Drug Review

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 

Clinlical Drug Development Phase 

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 

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

100 Months! 

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

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 

What are the major areas of Preclinical Studies? 

• 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) 

PHASES OF CLINICAL TRAILS 

Phase 0 

- 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 

What is a microdose?

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 

What is Priclinical Data?

Subacute toxicity sutyd in ones species by two routes of administration 

PHASES OF CLINICAL TRAITS

Phase 1 

- 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 

PHASES OF CLINICAL TRAILS

Phase II 

- 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 

Whats are the objectives of Phase II? 

Primary Objective: Efficacy in patients

Secondary Objective: Saftey  issues