Federal Regulations
Drug Manufacturing
Biochemistry
Laboratory Tech
Study Design
100

What does the FDA stand for?

Food and Drug Administration

100

This demonstrates product quality via materials, components, and controlled spaces

Quality Control

100

These enzymes used in gene editing were originally evolved by bacteria to defend against viruses

Restriction Enzymes

100

Process by which bacteria intake foreign DNA from their environment

Transformation

100
This part of experiment does not change to provide a means of comparison

Control

200

What is the purpose of a IND?

To prove safety for testing in humans
200
During manufacturing, this department is involved in maintaining workspaces such as warehousing, transport, and large equipment maintenance.

Facilities

200

2 DNA strands in a double helix move in which direction?

Antiparallel

5'3 or 3'5 direction

200

Bacteria can form bridges to share DNA via direct cell to cell contact.

Conjugation
200

What is the term used to refer to an experiment or research performed through artificial or computer test models?

In Silico

300
This document acts as non-governmental guidance for appropriate interpretation of CFR regulations.

GFI (Guidance for Industry)

300

What laboratory device spins micro-volumes at high speed to separate components by density?

Microcentrifuge

300

What is the section of DNA where translation/replication of a gene is initiated?

promoter

300

Gel Electrophoresis primarily separates DNA fragments based on what?

Size, number of base pairs

300

This type of experimental trial involves both the researcher and subjects being unaware of who is receiving a treatment

Double Blind

400

After scientists in the 1970s were caught faking lab safety data, what rules were created to make sure lab test on animals are honest & reliable before any medicine can be tested in people?

CGLPs
400

What is the proper protocol for making a correction on an error in a formal laboratory notebook?

Cross through the mistake and initial

400

Which restriction enzyme shares an identical restriction site sequence with another restriction enzyme?

Isoschizomer

400

What does CRISPR stand for?

Clustered Regularly Interspaced Palindromic Repeats

400

This refers to a process where a scientific study is reviewed by other researchers and potentially repeated to ensure its validity before publication.

Peer Review

500

Which division of the FDA is responsible for regulating prescriptions, generic drugs, over-the-counter medications?

CDER 

Center for Drug Evaluation and Research

500

Phase 4 clinical trials are primarily responsible for which types of studies?

Long term outcomes

500

The strand of DNA during replication that forms in small fragments in the 5'3 direction is known as what.

Lagging Strand

500
This form of dna transfer via physical means is used primarily in Eukaryotic Cells

Transfection

500

A study that follows a large group of patients after administering a drug treatment to monitor effects would be considered what type of study? (3 Words)

Prospective Experimental Cohort

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