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512 Drug and Biologic

This class was created by Brainscape user Anuschka Merson. Visit their profile to learn more about the creator.

By: Anuschka Merson
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Decks in this class (13)

Biologics CMC
Increasing approvals of biologic ...,
First biosimilar approved in the ...,
Biological products include a wid...
52  cards
NDA Submission Process
New drug application nda 1,
Biological license application bla 2,
Both the nda and bla must provide...
62  cards
Label Regs Pharma
Primary purpose of labeling 1,
Critical role in drug safety and ...,
Importance of regulatory complian...
17  cards
Post Approval Activities
Life cycle management 1,
Quality 2,
Manufacturing 3
37  cards
Regulatory Pathways and Designation
Pure food and drug act 1906 1,
Definition of drugs 2,
Biologics act of 1902 3
32  cards
Generic Drugs
Definition generic drug 1,
Legal basis for generic drugs 2,
Basic generic drug requirements 3
18  cards
Chemistry Manufacturing and Controls
What is cmc 1,
Are there cmc sections in both in...,
What can be found in the cmc 3
11  cards
IND Studies
What does and ind seek 1,
What is the rugulation for and in...,
Whap applicaiton is 21 cfr 312 3
28  cards
PK/BD/BE/PD Studies
Pharmacokinetics 1,
Pharmacodynamics 2,
Absorption is 3
22  cards
IND Submission Process
What is the ind regulation number 1,
Ind s are exempt under 505 i from 2,
When is an ind required 3
36  cards
Combination Products
Definition of combination products 1,
Disruptive medicine innovation 2,
Future product strategy 3
27  cards
Pediatric Studies
First documented study in pediatr...,
When did systematic pediatric res...,
In the 19th centry what ids were ...
52  cards
Benefit Risk Assessment
Risk is related to 1,
Risk is 2,
Benefit is 3
8  cards

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512 Drug and Biologic

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