Any product used to diagnose, cure, treat, mitigate or prevent a disease
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What is the medicinal form?
The presentation of a drug in a dosage form suitable for administration to the public, i.e. a formulation
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Drug
aka the API
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Excipient
All the other components of a formulation other than the active drug
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Formulation
The process in which APIs and excipients are combined to produce a medicinal product
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Every branded medication has two names:
- the brand name
- the chemical name
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Brand name
Is given by the pharmaceutical R&D company and is a registered name
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Chemical name
Name for the API, which is decided by an expert committee
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Do both the chemical and brand name appear on the medication label and product literature?
Yes
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Trademark
Any word, name, symbol or design, or any combination thereof, used in commerce to identify and distinguish the goods of one manufacturer or seller from another and to indicate the source of goods
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How long does a trademark usually last for?
A trademark generally lasts as long as the trademark is used in commerce and is defended against infringement
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How long does a standard patent last for?
20 years but can be extended for another 5
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What is the objective of pharmaceutical R&D?
To convert synthesised chemical compounds into candidate drugs for development
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What does product development involve?
Converting candidate drugs into dosage forms for registration and sale
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What do pharmaceutical companies need?
A 'pipeline' of NCEs (New Chemical Entities)
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What is a blockbuster drug?
Where sales reach over US $1 billion per annum
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Models for blockbuster drugs need to change with...
Advances in pharmacogenomics/ personalised medicines
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Why might blockbuster drugs fracture the market?
As companies may focus on specific ailments/ therapies
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When does generic business kick in?
When a drug loses its patent
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Are profits for generic drugs much lower?
Yes
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Can generics also become blockbusters?
Yes
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Why have pharma R&D introduced lifecycle management?
To increase patent protection (through patenting of isomers of original drug etc)
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Are generic drugs more affordable for the patient?
Yes
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What is a generic drug?
A drug which is bioequivalent (in terms of its PK and PD properties) to a leading brand name
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Generic drugs must be identical (w respect to the 'innovator') in terms of:
- dose
- route of administration
-safety
-efficacy
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Generic drugs use a generic name, typically
the chemical name
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Are prescribers encouraged to prescribe using generic names?
Yes
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Why is this?
Generic medicines are equally effective and a lot cheaper. They also allow the pharmacist the widest choice of product to dispense (which is particularly important if there is a shortage of a certain product)
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However, there are some cases where a patient may need to stay on a branded medication
slight differences in rate of absorption may cause a big difference in therapeutic effect
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Modified- release preparations
Generic equivalents may absorb differently
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Lithium
Diff brands may vary widely in absorbtion and how the medicine becomes active
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Biological medicines
Copies of these complex medicines (called biosimilars) may not be automatically used as a substitute
Doctors need to reference to the specific manufacturer
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Other cards in this set
Card 2
Front
The presentation of a drug in a dosage form suitable for administration to the public, i.e. a formulation
Back
What is the medicinal form?
Card 3
Front
aka the API
Back
Card 4
Front
All the other components of a formulation other than the active drug
Back
Card 5
Front
The process in which APIs and excipients are combined to produce a medicinal product
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