Drug Development

Front 1

Preclinical Investigation

Back 1

Oftern begin IN VITRO with studies in cell cultures and/or binding affinties in isolated tissue
IN VIVO reserach on various animal models is perofrmed if potential pharmacological activity seen

Front 2

Investigaton New Drug (IND) Approval

Back 2

If preclinical investigation shows degree of pharmacological activity AND low toxicity the IND is submitted to FDA to begin clinical trials

Front 3

Clinical Trials
Careful Planning

Back 3

Done to obtain MAXIMUM useful data with MINIMUM harm to pt.
Protocol CANNOT be altered while study is in progress unless dangerous condition arises

Front 4

Clinical Trials
Control Groups

Back 4

Placebo group must be included where possible
Must be identical in look to active and often times given older establish drug for comparison

Front 5

Clinical Trials
Double Blind Format

Back 5

Where possible NEITHER pt. nor Dr. should know whathe pt. is receiving.
Does NOT mean pt. should be unaware involved in a drug test
Consent form MUST be signed by pt. and SHOULD be sighned my witness and Dr.

Front 6

Clinical Trials
Randomization

Back 6

Before first pt. enrolled random #'s employed for a pre-determined list of sequence for drug and placebo

Front 7

Offical Phases
Phase I

Back 7

FIRST time himans receive investigational drug
Most are healthy young and VOLUNTEERS
Non-blinded phase to collect pharmokinetic data
Highly toxic drugs may be used on actual pt's

Front 8

Official Phases
Phase II

Back 8

Most drugs FIRST time new drug given to PT. with target disease
SAFETY and EFFICACY examined here
Final dosage form should be established here

Front 9

Official Phases
Phase III

Back 9

Depending on results from II can be limited or extensive
Several 100's to 1000's tested

Front 10

When are animal testing stopped during clinical trials?

Back 10

Animal testing is continued with emphasis on
Chronic Toxicity
Teratogenicity
ADR on fertility

Front 11

New Drug Aplication (NDA) Approval

Back 11

Both clinical and preclinical data submitted to FDA if approved marketing of new drug begins

Front 12

Phase IV
Post Marketing Surveillance

Back 12

Health professionals submit ADR to FDA
Some toxic rxn's may be seen now not seen before so EXTREMELY IMPORTANT in determining safety

Front 13

Resaons why drug may produce effects not seen in Phases I-III

Back 13

Patients: Before; Homogeneous After; Heterogeneous
Doctors: Before; Specialists After; Non-specialists
Dose: Before; Monitored After; Not Monitored
Use of Other Drugs: Before; Usually none After; Often