9 januari: lifecycle of a drug Flashcards

1
Q

What do you need to prove to obtain market authorisation application (3)

A

Safe
efficacious
clean and reproducible manufacturing

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2
Q

What makes drug development difficult (4)

A
  1. Complex (laws, multidisciplinary, technical)
  2. expensive
  3. full of risks
  4. short return of investment
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3
Q

What is the difference between medical device CTs and IP CTs? Provide reasons as to why it might be easier ánd more difficult.

A

Differences:
MDs are cheaper to develop and have greater success percentage, but endpoints are harder to measure, there is a smaller market, and standardization and blinding is more difficult.

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4
Q

Which phase?: A double-blind, dose-finding, randomised, placebo-controlled, multicentre study with drug A vs drug B in patients with moderate to severe disease

A

Phase II

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5
Q

An open label, randomised, cross-over, single-centre study to compare pharmacokinetics of drug A vs drug B in healthy volunteers

A

Phase I

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6
Q

an open label, randomised, parallel group, multicentre study to compare the eficacy and safety of Drug A vs drug B in patients with moderate to severe disease. This is a trial to investigate a new way of administration of 2 already known and marketed ashtma treatments (drug B) given together in one combination (drug a)

A

Phase III

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7
Q

Describe pre-clinical (processes, subjects, objectives)

A

Synthesis and purification. Within in silico, in-vivo, in-vitro. Objective: test safety and bio activity (e.g. toxicity, fertility, mutagenicity, carcinogenicity).

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8
Q

Describe phase I (objectives, subjects, design)

A

In-humano, w/ healthy volunteers, to test safety and tolerability. Open, single blinded, placebo controlled. Max Tolerable Dose is determined.

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9
Q

Describe Phase II (objectives, subjects, design)

A

Dose determination, check for efficacy and short term safety. Design: selected subjects, based on diseases. Open, double-blinded, placebo-controlled. Multiple sites.

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10
Q

Describe Phase IIIa en IIIb (objectives, subjects, design)

A

III = comparison to golden standard
IIIa: safety, efficacy, benefit analysis. Prior to submission. Use GS of CTs. n >
IIIb: Cost-effectiveness. Acquire data for MAA & publication. n»

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11
Q

Describe Phase IV (objectives, subjects, design)

A

(not mandatory). After MAA, check for long term safety and efficacy, cost effectiveness and market position.

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12
Q

What type of clinical trial is post marketing survellaince?

A

Observational

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