Lecture 1 Flashcards
what is the focus/aim of academia writing
-record of new knowledge
what is the focus/aim of pharmaceutical writing
record of new/better drug for indicated disease
name the 4 types of science documentation
-lab notebooks
-patents applications
-peer reviews
-regulatory submission
true or false: lab notebooks are super restricted in pharmaceutical
true
what are regulatory submission
technical reports and clinical trials reports for each of the different sections IND (investigational new drug app) , or NDA (new drug app)
what do docs look at
the highlights of prescribing information
what is the indication
specific disease state, targeted patient population
what are the adverse reactions
side effects and immununogenicity
what are the drug interaction
PK effects on other drugs
what are pharmacodynamics
what does the drug do to the body
what are pharmacokinetics
what does the body to the drug
what is single blind
author don’t know who is the reviewer
what is double blind
the author nor the reviewer know each other
what are open reviewers
anyone can know who is the reviewer
what is post pub review
review after the atricle has been published