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2042

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

By: Jack McDonald
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Decks in this class (17)

weeks 1-3
Target product profile,
Sections of the tpa not contained...,
Efficacy component of tpp
22  cards
packaging
Types of glass,
Plastic,
Metals
6  cards
Pre-Clinical and Clinical PK models
In vitro pk characteristic determ...,
Physiological based pk models,
Allometric scaling
8  cards
drug approval process
Milestone 1,
Milestone 3,
Milestone 2
10  cards
Topic 3: Product specification and pharmacopiea
1 have an understanding of the pu...,
Structure of a product specification,
Interplay between a product speci...
3  cards
Topic 4: bioequivalence and biowaivers
Generic vs innovator getting to m...,
Biosimmilars
2  cards
Topic 5: Labelling and packaging
Parts 1 2 and 3 in important aspe...,
Issues which can arise from the i...,
Types of glass used in packaging
5  cards
TOPIC 6: Pre-clinical testing: safety
Ich guidelines,
Dose ranging study,
Order of exploratory studies
14  cards
Topic 7: Preclinical PK studies
Data needed to predict the likely...,
Design of a pre clinical trial,
Principles of allometry
3  cards
Topic 8: clinical trials
Phase 1 part 1 purpose,
Design of a phase 1 clinical tria...,
Phase 1 subject selection
11  cards
Topic 9: Clinical Trial considerations for different formulations
Clinical trial issues for biologi...,
Disposition characteristics,
Tmdd how to account for it and ef...
12  cards
product specifications
Specification,
Analytical procedures,
Validation of the analytical proc...
5  cards
Designing a phase 1 clinical trial
Determining pk linearity f and sa...,
Determining pk linearity f and sa...,
Determining pk linearity f and sa...
4  cards
Design a phase 2 clinical trial
Phase 2 define the control group ...,
Phase 2 define study design in te...,
Phase 3 patient populations
4  cards
special formulation clinical trials
Explain the shape of the mab curve,
Dosing intervaal,
What drives eliminaation
4  cards
Intellectual property and Marketing
Code of conduct,
Salient points of the code,
The pharmaceutical benefits scheme
11  cards
Salient points of boyd lectures
Nda components,
Nda purpose,
Pharmacopeia monograaphs
6  cards

More about
2042

  • Class purpose General learning

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