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Decks in this class (35)
Reg Intro 1
What does medicine regulation cov...,
What is medicine regulation def 2,
Guidelines positions and concept ...
38
cards
QSAR & High Output Screening
Chemical space outline 1,
Hit compound def 2,
Hit series def 3
29
cards
Reg Intro 2
Blank 1
1
cards
Innovation & Entrepreneurship
Entrepreneurship def 1,
Invention def 2,
Innovation def 3
25
cards
Drug Discovery History
What supports an innate understan...,
What supports innate understandin...,
Ancient medicine overview 3
27
cards
Drug Targets
4 stages of drug life cycle 1,
3 stages on in vitro and in vivo ...,
Human testing 3
30
cards
Pre-Clinical Studies
Pre clinical developments stages 1,
Purpose of preclinical development 2,
Regulatory agencies outline 3
37
cards
Rational Drug Design (TEL Intro)
Primary protein 1,
Secondary proteins 2,
Tertiary protein 3
12
cards
Chemistry Manufacturing Controls (CMC)
Clinical trial def 1,
How to get approval for clinical ...,
Clinical trial ethics considerati...
33
cards
Physicochemical Properties of Drugs
Physicochemical properties outline 1,
Pharmacuetical phase phase 1 outl...,
Pharmacokinetic phase phase 2 out...
27
cards
UV, IR & Mass Spectrometry
Electromagnetic spectrum decreasi...,
Spectroscopy outline 2,
Uv vis spectroscopy advantages 3
32
cards
Regulatory Life Cycle Management
Who is responsible for a medicina...,
Components of mah pharmacovigilan...,
What happens when unexpected even...
28
cards
Drug Delivery Polymers 1
Polymer outline 1,
Polymers in dosage forms 2,
Bioresorbable polymer 3
37
cards
Drug Delivery Polymers 2
Polymerisation classes 1,
Polymerisation mechanisms how pol...,
Polymerisation techniques polymer...
27
cards
Nuclear Magnetic Resonance (NMR) Principles & App.s
Nuclear magnetic resonance outline 1,
Nmr principle 2,
How are magnets kept cold in nmr 3
25
cards
Polymer Characterisation
Different drug deliver polymers c...,
Polymeric drugs outline 2,
Glatiramer acetate outline 2
26
cards
Chromatography Principles & Applications
Chromatography outline 1,
Homogenous mixture 2,
Preparative chromatography 3
28
cards
Preformulation 1
Preformulation def 1,
Examples of physical properties 2,
Examples of chemical properties 3
44
cards
Preformulation 2
Solid state property 1,
Surface area of a sphere 2,
Methods of analysing particle size 3
32
cards
Chemical Stability 1
Dosage form stability def 1,
What is stability dependent on 2,
Degradation results in 3
55
cards
Chemical Stability 2
Importance of stability testing 1,
Stability testing outline 2,
Stability testing types 3
37
cards
Manufacturing Regulation 1
Decision def 1,
Recommendation def 2,
3 registration procedures in ema 3
44
cards
Manufacturing Regulation 2
Root cause analysis rca outline 1,
Rca process 2,
Quality risk management qrm 3
12
cards
Authorisation & HTA Process Link
Efficacy def 1,
Effectiveness def 2,
Ideal conditions outline 3
23
cards
Clinical Trial Design
NOT FINISHED (Why are protocold required)
23
cards
Process Development
What dictates quality by design 1,
Quality by design principle 2,
Quality by design cycle steps 3
29
cards
Technology Transfer
Technology transfer def 1,
Successful relocation def 2,
Sending unit def 3
17
cards
Process Validation
Fda process validation def 1,
Ema process validation def 2,
Purpose of process validation 3
24
cards
Process Control
Continuous fda on going ema proce...,
Fda continued process verification 2,
Data collected in fda continued p...
29
cards
QP Roles & Responsibilities
Qualified person outline 1,
People the qp are responsible for 2,
Qp european pharmacopeia 3
21
cards
Bioavailability and Bioequivalence
Bioavailability f outline 1,
Area under curve auc outline 2,
Max bioavailability calc 3
27
cards
Generics Intro
Patent vs data protection 1,
Types of patent 2,
Composition patent outline 3
37
cards
Getting Drugs To Market
NOT FINISHED
33
cards
Health Technology Assessment
Examples of healthcare costs 1,
Driving healthcare costs 2,
Gain share outline 3
49
cards
IVIV
In vitro def 1,
In vivo def 2,
Iviv outline 3
30
cards
More about
Drug Life Cycle
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- Program type Unspecified
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- Instructor Unspecified
- Standards Unspecified
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