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1
Biopharmacology
Branch of pharmacology that studies the use of biologically engineered drugs
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insulin 1982
lily
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Biologics
A group of varied medicinal products such as vaccines, blood products, allergenics and proteins.
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Biopharmaceuticals
Derived from life forms existing in nature, substances created using biotechnology.
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Biopharmaceuticals sources?
Plants and animals
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Recombinant therapuetic proteins:
Artificial forms of recombinant DNA that have been created by combining or inserting one or more DNA strands into a single molecule
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Earliest example of biopharma.:
Louis Pasteur’s work - Penicillin in 1857
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Cerezyme indication
Gaucher's disease
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Hyalgan indication
Rheumatoid Arthritis
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Leukine indication
Neutropenia
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Humira (adalimumab) indication
Rheumatoid Arthritis
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Epogen (erythropoietin)
Anemia from cancer therapy, chronic renal failure
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Remicade (infliximab) indication?
Chrons disease
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Herceptin (Trastuzumab) indication?
Breast cancer
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Orencia (Abatacept) indication?
Rheumatoid arthritis
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Stelara (Ustekinumab) indication?
psoriasis treatment
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FDA approval timeframe?
Approximately 12 years to move a drug from the experimental sage to the pharmacy
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pre-clinical phase
The new drug is tested against a targeted disease through laboratory and animal study
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Next 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
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Time frame IND
7 years
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NDA
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 (
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First Genetically engineered drug approved:
rHI aka Humulin Insulin
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Hepatitis B vaccine made when?
1986
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Pulmozyme indication
Cystic Fibrosis
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Alferon N Indication
Genital warts
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Steps in genetically engineering drugs
1. Isolate the desirable gene
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2nd step in genetically engineering drugs
2. GEne is inserted into a vector
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3rd step in genetically engineering drugs
3. Scientsts use the vector to transform the cells of another organism
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fourth step in genetically engineering drug
4. The GMO is isolated from cells that did not take up the vectoe
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Stem cells when first time?
1998
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Patent :
Gives a company the sole and exclusive rights to manufacture and sell a drug (
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Allergenic:
Having the capacity to induce and allergy
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Vector:
An organism that does not itself cause disease but spreads it by distributing pathogens from one host to another.
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Drug info insert purpose
is to educate the pt on the medication they are taking
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Orencia Gx
Abatacept
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Stelara
Ustekinumab
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Remicade
Infliximab
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Erythopoietin indication
Anemia from cancer, therapt, chronic renal failure
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Entanercept indication
Rheumatoid artheitis and psoriasis
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Alefacept indication
Psoriasis
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Adalimumab bx:
Humira
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Trastuzmab bx:
Herceptin
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Alefacept bx:
Amevive
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