Chapter 2 Lec Flashcards
Differentiate the effect and potency of the test agent from those of control
Bioassaya
Ability of cells w the potential to produce a desired antibody
Monoclonal antibody
Body’s means of transforming nonpolar molecules to polar compounds
Biochemical transformation
Useful in treatment of diabetes mellitus
Also has anti tumor capabilities
Periwinkle or vinca rosea
Chemical alteration
Molecular modification
Basic techniques that has the ability to manipulate and produce proteins
Recombinant DNA and monoclonal antibody
Has the potential to produce any protein
Genetic material can be transplanted from higher species to a lowly bacteriun
Recombinant dna
Medical intervention based on the modification of the genetic material
Human gene therapy
Molecular modification to design a drig that interferes with the known biochemical pathway
Mechanism based drug design
Produce the specifically desired effect
No side effects
Goal drug
Undertaken to reveal any effect of an active ingredient on mammalian reprod
Reproduction studies
Clinical trial materials
New drug, placebo and the drug product which the new prof is to be compared
Prototype chemical compound that had a fundamental desired biologic or pharmacologic activity
Lead compound
Involves testingg of large numbers of synthetic organic compounds
Random or un targeted screening
A compound that requires metabolic biotransformatiin after administration to produce the desired pharmacologically active compound
Prodrug
Allows vets to prescribe extra label uses or animal drugs and human drugs for animals
Animal medicinal drug use of clarification act of 1994
2 animal species for drug metabolism
Rodent and dog
Special care of the prescriber and patient in the use of the drug
Precautions
First pass effect
Drugs thru liver and exposure to hepatic enzymes
45% sucess
Phase 2
20-100 subjects
Phase I- healthy subjects
Controlled in which atleast one of the parties does not know which producy is being administered
Blind studies
Quantitative range or amount of drug that may be prescribed safely
Usual dosage rangr
2 weeks at 3 dosage lvls to 2 animals
Subacute or subchronic studies
Used to gather supplemental info that may contain support certain labeling requests
Phase 3b studied
To test if the comp can affect gene mutation
Genotoxicity
Speed at which a drug substance dissolves in a medium
Dissolution rate
Undertake when the comp has shown sufficient promise as a drug to enter human clinical trials
Carried out in rats and mouse strains
18-24 months
Carcinogenic studies
Orphan drug act of 1983
Rare diseases that affects lower than 200,000 people
Objective is to make promising drugs available to desperately ill patients
Treatment IND
67% success
Phase I
Controlled clinical studied to evaluate effectiveness of a drug in patients with the condition for which the drug is intended for
Phase 2- unhealthy subjects
100-1000 patients
Last for 1-4 trs
Safety effectiveness and sosge
5-10%
Phase 3
Fda approved indication prevention or diagnosis
Indication and usage
May influence a drugs action by altering its pharmacokinetic profile
Genetic polymorphism
Amount that is enough to achieve the drugs optimum therapeutic effect
Dose of drug
Nonclinical lab studied may be omitted
Duplicates or generic copies
Abbreviated new drug application
Predictable and unpredictable undesired effects
Adverse rxns
Descriptjon of the adverse reactions and safety hazards
Warnings
Summary of all actions of drugs
Clinical pharmacology
A tranquilizer and a hypotensive agent
Reserpine
First human gene therapy
Adenosine deaminase deficiency
Risk of use clearly outweighs any beneficial effecy
Contraindication
Biochemical transformation results in..?
Production of metabolites
Ability to endure the influence of the drug
Tolerance
Rectal buccal administration
Drugs are absorbed into the systemic circularion through blood vessels
Initial intro
Purpose of assessing safety
Phase I - healthy subjects
deals w the adverse or undesired effects of drugs
Toxicology
Capable of examining 15,000 chem compounds a week using 10-20 biologic assays
High throughout screening
Determine the toxic effects over a short period of time
Acute toxicity studies
