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Overview of Drug Development Process

A drug is a substance that produces physiological effects in the body, while a medicine is a drug that provides therapeutic benefits for diseases. The drug development process typically takes around 14 years and costs about $2 billion, involving phases such as target identification, validation, preclinical evaluation, and clinical trials. Ethical considerations and adherence to Good Clinical Practice (GCP) are essential throughout the clinical trial phases.

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15 views2 pages

Overview of Drug Development Process

A drug is a substance that produces physiological effects in the body, while a medicine is a drug that provides therapeutic benefits for diseases. The drug development process typically takes around 14 years and costs about $2 billion, involving phases such as target identification, validation, preclinical evaluation, and clinical trials. Ethical considerations and adherence to Good Clinical Practice (GCP) are essential throughout the clinical trial phases.

Uploaded by

adipgtr3
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd

What is a drug?

 A drug is a substance that has physiological effect when introduced


to the body
 A medicine is a drug that provides a therapeutic benefit for a
disease

Typical drug development timeline

 Takes around 14 years and costs around $2 billion to develop a


potential drug candidate from the laboratory to the pharmacy.

Choosing a disease target

 How common is the disease?


 How well do we understand the disease?
 Is there unmet need? Do people need a new medicine?
 Are other groups already working on this
 Can we make a new medicine?

Target identification- earliest phase of drug development

 Consideration of the disease context


 Identify targets which could be used to develop a pharmaceutical

Target validation

Target validation endpoint

 Tractable
 Valid

Hit qualification and lead discovery

 Assays that show the drug affects a disease process by interacting


with the target.
 Hit qualification is employed to rule out false positives and validate
hits that interact with the target in a productive way

Lead optimisation

 When a hut becomes a lead more information about mode of action


is desired
 Often involves solving protein structures usually in complex with
lead compounds to locate binding sites

Preclinical evaluation

 When a compound show promise in in vitro studies a researcher


submits a proposal for in vivo studies
 Animal models are important in aiding scientists translate findings
to humans as animals and humans are similar.

Choosing the right model

 Mice are often used since their entire genome is well known
 Different animals are translatable in different disease areas:

- E.g. Zebrafish -model for embryonic development

- E.g. Turquoise killifish-model for aging

 Genetic alterations can make animal models more reliable


- E.g. Engineering a mouse with a human immune system
 It’s important that models are accurate so we can minimise animal
use.

Preclinical evaluation

 Replacement
 Reduction
 Refinement

Clinical trials and their various phases

Phase I – First test in humans

 10-50 patients
 Primary focus is if the drug is tolerable

Phase II – First test in humans with a disease

 100s of patients
 Primary focus is if the drug causes beneficial effects

Phase III – Can take years

 1000s of patients
 Primary focus is if the drug is better than the current gold standard
(will it be useful to what we have now)

Ethical clinical trials

 All clinical trials must follow Good Clinical Practice (GCP)

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