U4.2: DRG DEVELOPMENT & REGULATION Flashcards
4 components of Drug Discovery
- Chemical modification
- Random screening of the biological products
- Rational drug design
- Biotechnology and cloning using gene
3 components of Drug Screening
- Biologic products
- Chemical synthesis
- Lead compound
The amount of animal testing required before human studies begin is a function of the propsoed use and the urgency of the application
Preclinical Safety & Testing
Preclinical Safety & Testing
Administration of single dose to the lethal doses in at least 2 species
Acute Toxicity
Preclinical Safety & Testing
manifests about 2 to 4 weeks
Subacute Toxicity
Preclinical Safety & Testing
Test wherein it will be conducted between 6 to 24 months exposure to the drug
Chronic Toxicity
Preclinical Safety & Testing
2 and 3 tests are conducted for at least the length of time proposed for human
Chronic Toxicity
Preclinical Safety & Testing
Induction of developmental defects in somatic tissues of the fetus
Teratogenicity
Preclinical Safety & Testing
Induction of changes in the genetic material of animals of any age inducing heritable abnormalities
Mutagenicity
Mutagenicity
Standard in vitro test for mutagenicity
Ames Test
Mutagenicity
Uses a special strain of salmonella bacteria that naturally depends on specific nutrients in the culture medium
Ames Test
Mutagenicity
Loss of this dependence during exposure to the test drug signals mutation
Ames Test
Evaluation in Humans
Usually last for 4 to 6 years before completion and approval
Clinical Trials
T/F Clinical trials are natural variable history of the disease
T
T/F Clinical trials use a cross-over design
T
T/F Clinical trials two groups is given the standard
F; 2 groups of patient, 1 group given the standard
T/F Presence of other disease and risk factors should be considered with clinical trials
T
T/F You have to critically select the patients that conduct clinical trials
T
Clinical Trials
Careful evaluation of the dose-response relationship in a small number of normal human volunteers (20 to 30)
Phase I
Clinical Trials
Except for trials of chemotherapeutic drugs and other highly toxic drugs carried by administering to patients with target disease
Phase I
Clinical Trials
Evaluation of a drug in a moderate number of patients (100 to 300) with the target disease
Phase 2
Clinical Trials
Placebo or posiitve control is included in a single-blind or double-blind study
Phase 2
Clinical Trials
Carefully controlled conditions and very closely monitored
Phase 2
Clinical Trials
Determines if the drug has the therapeutic effects
Phase 2
Clinical Trials
Large design involving many patients (1,000 to 5,000) or more in many centers and many clinicians who are using the drug in the manner proposed for its general use
Phase 3
Clinical Trials
Placebo, double-blind crossover trial
Phase 3
Clinical Trials
Explore the spectrum of beneficial actions of the new drug, compare with older/ standard therapies
Phase 3
Clinical Trials
Discover toxicities
Phase 3
Clinical Trials
Toxicities that occur very infrequently will be detected and reported early enough to prevent major therapeutic disasters
Phase 4
Clinical Trials
Postmarketing surveillance
Phase 4
Clinical Trials
Not rigidly regulated by the Bureau of Food and Drugs
(BFAD)
Phase 4
