7). Clinical safety data management definitions and standards
Ans: ICH E2A
8). Safety pharmacology studies for human pharmaceuticals
Ans: ICH S7A
9). Electronic records, electronic signatures
PaperStoc.com Page 1 of 27
, Ans: 21 CFR Part 11
10). Informed consent
Ans: 21 CFR Part 50
11). Financial disclosures
Ans: 21 CFR Part 54
12). Institutional review board
Ans: 21 CFR Part 56
13). Ind application
Ans: 21 CFR 312
14). New drug application
Ans: 21 CFR 314
15). Investigational device exemption
Ans: 21 CFR 812
16). 21 cfr part 814
Ans: pre market approval of medical devices
17). 45 cfr part 46
Ans: Federal Research
18). Studies that investigate the potential undesirable pd effects of a substance on
physiological functions in relation to exposure in the therapeutic range or above
Ans: Safety Pharmacology Studies (Pre-Clinical)
PaperStoc.com Page 2 of 27
, 19). 1) to identify undesirable pd properties of a substance that may have relevance to its
human safety.
2) to evaluate adverse pd and/or pathophysio effects of a substance observed in
toxicology studies
3)to investigate the mechanism of the adverse pd effects observed and/or suspected
Ans: Drug Development Safety Pharmacology Study Objectives (3)
20). 1) cardiovascular
2)respiratory
3)cns
Ans: Three vital organ considered highest priority
21). 1) pk and toxicokinetic
2) single dose toxicity
3) repeated dose toxicity
4) local tolerance
5) genotoxicity
6) carcinogenicity
7) reproduction toxicity
8) supplemental studies if needed
Ans: Types of Non-Clinical Studies (Animal Trials)
22). Study that investigates the mode of action and/or effects of a drug substance in relation
to its desired therapeutic target
Ans: Primary Pharmacodynamic Studies
23). Studies that investigate the mode of action and/or effects of a drug substance not related
to its desire therapeutic target
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Academik001. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $14.99. You're not tied to anything after your purchase.
