Experimental Design
The part of an experiment that remains unchanged to provide a standard of comparison
Control
Clinical trials involve human testing
This federal agency is responsible for the regulation of the production of pharmaceuticals in the United States
FDA - Food and Drug Administration
These circular extrachromosomal DNA fragments found in bacteria are useful in engineering specific traits to be expressed.
Plasmids
A cell that has its cell membrane made permeable either through heat or via a bacteriophage has undergone this process.
Lysis
In an experimental study, how many variables would be ideal to change in order to ensure the most accurate results
1
Preclinical trials primarily test for what aspect of a new drug/product?
Safety
All CGMPs are derived from this federal regulatory code.
CFR - Code of Federal Regulations
These end products of translation allow for traits in organisms to be expressed.
This method of transformation involves using bacteriophages to transfer genetic material
Transduction
A study that involves following a cohort and recording their health outcomes related to smoking habits is what type of study?
Observational Cohort
The application of items such as SOPs, Safety Documentation, and laboratory notebook documentation are most applicable at this stage of drug development.
Preclinical trials
These best practices regulate stages of drug development such as lab procedures, manufacturing, and documentation
CGXPs
Current Good Practices
The direction of movement within electrophoresis occurs because of this specific trait of DNA
Negative Charge
37 Celsius
This part of a research study communicates the raw data and findings of an experimental or observational study
Results
Individuals within this team/department are responsible for seeing that all other departments are compliant with federal regulations
Quality Assurance (QA)
This document must be submitted to the FDA for new synthetic pharmaceutical products.
NDA - New Drug Application
These short DNA strands are formed while synthesizing DNA in the lagging strands.
Okazaki Fragments
Transfection is a form of DNA transformation used to transform which types of cells
Eukaryotic
This value in a statistical analysis is meant to determine the chance of whether the outcome of your data occurred by random chance
P-Value
Phase 3 Clinical Trials are meant to test which element of a drug
Efficacy
Translate the following sentence.
According thee outlined CGMPs, current SOPs dictate that calibrations should be corrected according to GDP guidelines. IND applications should also be recorded in our Pre market approval application
Current Good Manufacturing Practices
Standard Operating Procedures
Good Documentation Practices
Investigational New Drug Application
This enzyme unwinds DNA during replication
Helicase
This method of bacterial transformation involves using small jolts of electricity to create small pores in bacterial cell membranes
Electroporation