1Biopharmacology
Branch of pharmacology that studies the use of biologically engineered drugs
3Biologics
A group of varied medicinal products such as vaccines, blood products, allergenics and proteins.
4Biopharmaceuticals
Derived from life forms existing in nature, substances created using biotechnology.
5Biopharmaceuticals sources?
Plants and animals
6Recombinant therapuetic proteins:
Artificial forms of recombinant DNA that have been created by combining or inserting one or more DNA strands into a single molecule
7Earliest example of biopharma.:
Louis Pasteur’s work - Penicillin in 1857
8Cerezyme indication
Gaucher's disease
9Hyalgan indication
Rheumatoid Arthritis
10Leukine indication
Neutropenia
11Humira (adalimumab) indication
Rheumatoid Arthritis
12Epogen (erythropoietin)
Anemia from cancer therapy, chronic renal failure
13Remicade (infliximab) indication?
Chrons disease
14Herceptin (Trastuzumab) indication?
Breast cancer
15Orencia (Abatacept) indication?
Rheumatoid arthritis
16Stelara (Ustekinumab) indication?
psoriasis treatment
17FDA approval timeframe?
Approximately 12 years to move a drug from the experimental sage to the pharmacy
18pre-clinical phase
The new drug is tested against a targeted disease through laboratory and animal study
19Next step IND
(Investigational New Drug) Shows the results of the animal pharmacology and toxicology studies that have already been done, along with detailed information and protocol for future clinical studies, also includes the chemical structure of the compound and the company’s plan for manufacture
21NDA
New Drug application) Can be filed after the IND phases are complete, can take up to 30 months for approval, one the FDA gives approval the drug becomes available for physicians to prescribe (
22First Genetically engineered drug approved:
rHI aka Humulin Insulin
23Hepatitis B vaccine made when?
1986
24Pulmozyme indication
Cystic Fibrosis
25Alferon N Indication
Genital warts
26Steps in genetically engineering drugs
1. Isolate the desirable gene
272nd step in genetically engineering drugs
2. GEne is inserted into a vector
283rd step in genetically engineering drugs
3. Scientsts use the vector to transform the cells of another organism
29fourth step in genetically engineering drug
4. The GMO is isolated from cells that did not take up the vectoe
30Stem cells when first time?
1998
31Patent :
Gives a company the sole and exclusive rights to manufacture and sell a drug (
32Allergenic:
Having the capacity to induce and allergy
33Vector:
An organism that does not itself cause disease but spreads it by distributing pathogens from one host to another.
34Drug info insert purpose
is to educate the pt on the medication they are taking
38Erythopoietin indication
Anemia from cancer, therapt, chronic renal failure
39Entanercept indication
Rheumatoid artheitis and psoriasis
40Alefacept indication
Psoriasis
42Trastuzmab bx:
Herceptin