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Definitions of a Drug:
- Article intended for and having as their
main use the diagnosis, cure, mitigation,
treatment or prevention of disease in
man and other animals
- Article recognized by monograph in the
compendia
- Article (other than food) used to affect
the structure or any function of the body
of man and other animals
- Article used as a component of any of
the previously mentioned articles.
Active Ingredient
- any component that is intended to
furnish pharmacological activity or other
direct effect in the diagnosis, cure,
Pharmaceutical Product Development
mitigation, treatment or prevention of
● Drug Discovery
disease or to affect the structure or
- Determine target disease.
function of the body of man or other
- Develop hypothesis for a
animals
mechanism of treatment.
The Pharmaceutical Product Development
- Evaluate hypothesis.
Process
- Determine feasibility of producing
- Research activities directed to the
and evaluating the selected
creation of new drugs for new products
compound.
- New drugs may be intentionally or
● Screening
accidentally produced from natural
- Combination Chemistry
sources or by chemical synthesis
- Make many possible compounds
at one time.
- Focus on quantity of possible
compounds, not purity of each.
- High Throughput Screening
- Test hundreds at a time for
activity.
- Process requires serious technology.
- 1 in 10,000 makes it to the
market.
Two Main Stages of Drug Development
● Preclinical Research
- involves synthesis and purification
testing in the lab and animal testing
- thousands of compounds are tested
Sequence of Events in Pharmaceutical
in preclinical research before a
Product Development
handful are chosen to enter the
second stage, which requires filing
Perspectives in Pharmacy
of finding out years later in phase II or Phase 1 trial is not used to see if the
even phase III clinical trials that the drug drug is effective, only that it is mainly
doesn’t act as expected to based on lab safe for humans to use.
studies - Some of the questions researchers may
- If there are problems with the way the be looking to answer about a drug with a
drug is absorbed or acts in the body, this Phase 1 trial include:
should become clear very quickly in a • Does it cause any serious side
phase 0 clinical trial. effects?
- Not yet being used widely, and there are • Are patients able to tolerate the drug?
some drugs for which they wouldn’t be • What's the safest route of
helpful. administration (such as pill, injection,
- Studies are very small, often with fewer infusion)?
than 15 people, and the drug is given • How is it metabolized by the body?
only for a short time. • What's the highest dose that is
- They’re not a required part of testing a tolerable to patients?
new drug. ● Phase II
Phase I - Conducted on a larger group of people
- This phase consists of short-term to further evaluate the safety of the
clinical tests of the drug on 20 to 80 treatment and to determine how well it
healthy volunteers to determine basic works.
pharmacological and toxicological - Typically the drug is tested in 100 to 300
information in humans especially as patients.
regards safety. The FDA can stop - Dosage levels are experimented with to
clinical testing if they deem the drug find optimal dosage levels, and further
unsafe. information on safety is collected
- Studies that are usually conducted with - The main purpose of a Phase II clinical
healthy volunteers and that emphasize trial is to begin to assess whether a drug
safety. is effective while exposing as few people
- The goal is to find out what the drug's as possible to any unwanted side
most frequent and serious adverse effects.
events are and, often, how the drug is - All study participants will have been
metabolized and excreted. diagnosed with the condition that the
- The aims of this initial trial include: new medication has been designed to
- Determining that the drug is safe for treat.
humans ● Phase III
- Gaining information about proper - Designed to provide proof of the drug's
dosage amounts effectiveness in treating the target health
- Assessing side effects at different problem and to assess the risk vs.
dosage amounts benefits of using the drug
- Determining how the drug is - Drug is given to large groups of people
metabolized by the human body often numbering in the thousands (1,000
- Assessing the effect of the drug on to 3,000)
target symptoms - Data is gathered regarding side effects
- Phase I typically takes about one year, and optimal dosage amounts in order to
which is much shorter than other phases provide labeling and physician
of the trial period. prescription information
- The short time period is because a - Trials are tightly controlled and can take
Perspectives in Pharmacy
● Phase IV
- Generic Drug Product - Done in the post-marketing stages -
• Product that is comparable to after the Food and Drug
an innovator drug product in Administration (FDA) has approved
dosage form, strength, route of the product for general use
administration, quality, - Studies are conducted on hundreds
performance characteristics and to thousands of people
intended use. - Study answers the question "does it
• Generic drug applications are work over time and for purposes
termed "abbreviated" because other than what it was initially meant
they are generally not required to for?"
include preclinical (animal) and - done to continue monitoring the risks
clinical (human) data to establish and benefits of the drug
safety and effectiveness. - may look at the drug's effect on
• Instead, generic applicants are different subgroups of individuals
required to scientifically (such as different genders or ages)
demonstrate that their product is or to gather information about the
bioequivalent (i.e., performs in long-term effects of drug usage
the same manner as the - may be conducted in order to get
innovator drug). FDA approval for the drug to be
• Generic applicants are required used for a different purpose than the
to scientifically demonstrate that target symptoms it was originally
their product is bioequivalent approved for
(i.e., performs in the same
manner as the innovator drug).
• One way scientists
demonstrate bioequivalence is to
measure the time it takes the
generic drug to reach the
bloodstream in 24 to 36 healthy
volunteers.
• This gives them the rate of
absorption, or bioavailability, of
the generic drug, which they can
then compare to that of the
innovator drug.
• The generic version must
deliver the same amount of
active ingredients into a patient's
bloodstream in the same amount
of time as the innovator drug. -
bioequivalence
● Marketing Authorization (MA)
● Certificate of Product Registration
(CPR)
● Routine Commercial Production New
Product Launching Marketing