Midterm (Modules 2-7) Flashcards
What are some differences between small molecules and biologics
biologics are large, unstable, usually injected, and made from living things, resulting sometimes in a heterogeneity
What are the steps of making recombinant DNA
I really like fucking people
Isolate
Restrict and ligage
fermentation
purification
What is the difference between biotechnology and biosciences
biotechnology is creating a product using living things and biology where as biosciences is the study of biology
What form of DNA is patentable
cDNA
What is cDNA
using reverse transcriptase, you can make a complementary stand of DNA that does not have any introns. This is considered not natural
Name 3 mechanisms of therapeutic action for mABs
- alter immune response
- trigger cell death
- disrupt signaling proteins
What are the two requirements from researchers before beginning a clinical trial
review and approval from IRB and file a IND with the FDA
How long is a typical patent for
6-10 years
What is pharmacogenetics
how someones genetics influences how they respond to drugs
what is pharmacokinetics
what the body does to the drug
what is pharmacodynamics
what the drug does to the body, think pharmaco-D what the DRUG DOES
What types of actions could drugs have?
work directly on the receptor, block mechanism of action, stablize action, direct harmful chemical to destroy cell, directly beneficial chemical
What is the largest group of biologics sales
monoclonal antibodies
what are some ways recombinant DNA can be uses
crops and GMOs, therapeutics,
What are some advantages of making proteins
can be produced in large amounts in a short amount of time,
What are some disadvantages of making proteins
multiple proteins can form aggregates, unstable, physical nature of some proteins can change theraputic nature
What is clinical research
research conducted with human subjects for which the investigator directly interacts with the subject
what are the critical issues with a cross over study
- the order in which treatments are administered
- the carry-over between treatments/wash out period
what is the IRB
the guardian of clinical research, reviews, protocols, informed consent, and the risk benefit ratio
what things are exempt from the IRB
Emergency use, anything with taste and food
What needs to be submitted to the FDA?
clinical research investigator, conditions of study, purpose, contact information
What is the process to initiate clinical trials?
- submit investigation of new drug application
- product must have potential benefit and be proven safe in preclinical models
What is -omics
a holistic approach to looking at what is going on in the cells
what is systems biology
the integration of different -omics to understand what is happening
define genomics
a persons genome
define metagenomics
genetic material directly from environment
define pharmacogenomics
study of genetic variation effect on drug response
define pharmacogenomics
define proteomics
define bioinformatics
What 3 groups make up proteins
the r-group, the carb
what form of structure in a protein offers its function
secondary structure
what happens in the primary structure
sequence of amino acids
what happens at the secondary structure
disulfide bonds forming alpha helices and beta sheets
what happens at the tertiary level
three dimensional folding
what happens at the quaternary level
what happens to proteins as you increase temperature or effect pH
Denaturing,