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Perspectives in Pharmacy

Scope and Fields of Pharmaceutical ● Pharmacists in Education - responsible for


Services the nature and quality of pharmaceutical
education
PHARMACY - art and science of preparing, - “Shapes the course of profession”
dispensing and proper utilization of medications ● Wholesaling - products of hundred
and provision of drug related information to the manufacturers can be obtained from a single
public. agency.
- Preparing from natural and synthetic ● Pharmaceutical Journalism - offers rewarding
sources. experience for a limited number of pharmacists
- “The profession responsible for the with writing and editing skills.
appropriate use of medications, devices ● Government Services - Law Enforcers, Board
and services to achieve optimal Examiners, Food and Drug Analyst.
therapeutic outcomes” - Organization Management - offers an
-American opportunity for pharmacists who want to
Pharmaceutical Association be officers of national and provincial
PHARMACEUTICAL CARE - responsible associations.
provision of drug therapy for the purpose of - Philippine Pharmacists
achieving definite outcomes that improve a Association (PPhA)
patient’s quality of life. ● Medical Communication - embraces many
PHARMACIST - “educated and licensed to activities including computer handling of
dispense drugs and provide drug information.” medical data, creation of reference materials,
- Drug experts and research, evaluate, assemble and package
- Most accessible member of today’s information specifically for the end user.
healthcare team. ● Nuclear Pharmacy - applies principles and
DRUGS - articles intended for use in diagnosis, practices of pharmacy and nuclear chemistry to
cure, mitigation, treatment or prevention of produce radioactive drugs used for diagnosis
diseases. and therapy.
Pharmaceutical Services PPhA and its Affiliate Organizations:
PAPPI - Philippine Association of Pharmacist in
● Community Pharmacy - “Retail Pharmacy” the Pharmaceutical Industry
- This is the area of service mostly PACOP - Philippine Association of Colleges of
strongly identified with the word Pharmacy
pharmacy PSHP - Philippine Society of Hospital
● Industrial Pharmacy - Research, Production, Pharmacy
Quality Control, Distribution/Marketing CPAP - Community Pharmacist Association of
- Research: formulation of the the Philippines.
most suitable dosage forms. PAPVI - Philippine Association of Pharmacists
- Production: raw materials to in Veterinary Industry
finished product. DOH-LP - Department of Health-League of
● Hospital Pharmacy - Pharmacists dispense Pharmacists
medications, prepare sterile solutions, advice other IPAP - Industrial Pharmacists Association of
professionals and patients on the use of drugs, Philippines
monitor drug regimens and evaluate drug use. DSAP - Drugstore Association of the
● Clinical Pharmacy - said to be the saving grace to Philippines
the commercialism pervading the profession. FJCPPhA - Federation of Junior Chapter-
Philippine Pharmacist’s Association
YPG - Young Pharmacist Group Philippine.
Perspectives in Pharmacy

Pharmaceutical Product Development

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
Pharmaceutical Product Development
direct effect in the diagnosis, cure,
● Drug Discovery
mitigation, treatment or prevention of
- Determine target disease.
disease or to affect the structure or
- Develop hypothesis for a
function of the body of man or other
mechanism of treatment.
animals
- Evaluate hypothesis.
The Pharmaceutical Product Development
- Determine feasibility of producing
Process
and evaluating the selected
- Research activities directed to the
compound.
creation of new drugs for new products
● Screening
- New drugs may be intentionally or
- Combination Chemistry
accidentally produced from natural
- Make many possible compounds
sources or by chemical synthesis
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
Perspectives in Pharmacy

second stage, which requires filing - Objective 3: Recommended Dose


of an IND - Safe starting dose for clinical
- Pre-Clinical Testing trials
- Evaluate acute and short term - Objective 4: Physicochemical
toxicity in animals (one rodent, properties
one non-rodent). - Structural characterization
- Dose at increasingly high - Impurity identification
levels to induce toxicity. - Solubility assessment
- Determine lethal dose. - Stability
- Dose at normal levels for - Output – Raw Material
short and long term. Specifications
- Assess how drug is absorbed, ● Pharmaceutical Manufacturing Research
distributed, metabolized, and - The aim of pharmaceutical
excreted in animals. manufacturing development is to
- Primary goals of early preclinical design a quality product and its
development manufacturing process to
- to determine if the product is consistently deliver the intended
reasonably safe for initial use in performance of the product.
humans - The information and knowledge
- to determine if the compound gained from pharmaceutical
exhibits pharmacological activity manufacturing development studies
that justifies commercial and manufacturing experience
development. provide scientific understanding to
- to determine recommended dose support the establishment of the
for initial use in humans design space*, specifications, and
- to establish the physicochemical manufacturing controls.
properties of the drug: its ● Investigational New Drug (IND)
chemical makeup, stability, - Application filed by a sponsor to get
solubility FDA approval to conduct clinical
- Objective 1: Safety studies of an IND on human subjects
- Toxicity Studies - done on - Investigational new drug means a
experimental animals: murine new drug or biological drug that is
(rats or mice), canines (dogs), used in a clinical investigation. The
primates (monkeys), porcine terms ‘‘investigational drug’’ and
(pigs) ‘‘investigational new drug’’ are
- Dose at increasingly high levels deemed to be synonymous for this
to induce toxicity purpose.
- Determine lethal dose - Clinical investigation (or trial) means
- Dose at normal levels for short any experiment in which a drug is
and long term administered or dispensed to, or
- Objective 2: Pharmacologic activity used involving, one or more human
- Pharmacodynamics – what the subjects.
drug does to the body - Sponsor means a person who takes
- Pharmacokinetics – what the responsibility for and initiates a
body does to the drug ADME – clinical investigation.
absorption, distribution, - Contract research organization
metabolism excretion means a person that assumes, as
Perspectives in Pharmacy

an independent contractor with the evaluated extensively in the lab


sponsor, one or more of the and/or in animal studies.
obligations of a sponsor, e.g., design - Participating in a clinical trial can
of a protocol, selection or monitoring provide researchers with valuable
of investigations, evaluation of information on new treatments; in
reports, and preparation of materials some cases, it may also offer the
to be submitted to the Food and chance for a cure or improvement in
Drug Administration. a patient's quality of life that's not
- Investigator means an individual provided by standard therapy.
who actually conducts a clinical - Participation in clinical trials is
investigation (i.e., under whose voluntary, and individuals are
immediate direction the drug is allowed to discontinue the treatment
administered or dispensed to a at any time .
subject). - The purpose of clinical trials is to
- Sponsor-Investigator means an decide if a new medication or
individual who both initiates and treatment is safe and effective.
conducts an investigation, and under - Clinical trials are research studies
whose immediate direction the that are conducted on human
investigational drug is administered subjects to find more effective ways
or dispensed. to treat, prevent, or diagnose
- Subject means a human who disease.
participates in an investigation, - They may also be done to find
either as a recipient of the treatments with fewer side effects, or
investigational new drug or as a treatments that are easier for
control. patients to tolerate.
● Institutional Review Board (IRB) Phase 0
- Reviews, approves, and monitors - A recent designation for exploratory,
research involving human subjects first-inhuman trials conducted in
in order to evaluate the ethical accordance with the US FDA’s 2006
acceptability and the scientific Guidance on Exploratory IND Studies.
validity of any such studies. - They are exploratory studies that often
- An IRB is formally designated by an use only a few small doses of a new
institution in which research takes drug in a few patients
place, such as a hospital or - Also known as human microdosing
university. studies
- Research cannot begin until the - Designed to speed up the development
IRB approves. of promising drugs by establishing very
early on whether the drug behaves in
human subjects as was expected from
● Clinical Studies preclinical studies.
- Clinical trials are research studies - Involves the administration of single
done to evaluate whether a drug or subtherapeutic doses of the study drug
treatment is both safe and effective to a small number of subjects (10 to 15)
for people. to gather preliminary data on the agent's
- Prior to being used in clinical trials, pharmacokinetics (what the body does
drugs or procedures are first to the drug).
Perspectives in Pharmacy

- Help researchers find out whether the - Phase I typically takes about one year,
drugs do what they are expected to do. which is much shorter than other phases
- May help avoid the delay and expense of the trial period.
of finding out years later in phase II or - The short time period is because a
even phase III clinical trials that the drug Phase 1 trial is not used to see if the
doesn’t act as expected to based on lab drug is effective, only that it is mainly
studies safe for humans to use.
- If there are problems with the way the - Some of the questions researchers may
drug is absorbed or acts in the body, be looking to answer about a drug with a
this should become clear very quickly in Phase 1 trial include:
a phase 0 clinical trial. • Does it cause any serious side
- Not yet being used widely, and there are effects?
some drugs for which they wouldn’t be • Are patients able to tolerate the drug?
helpful. • What's the safest route of
- Studies are very small, often with fewer administration (such as pill, injection,
than 15 people, and the drug is given infusion)?
only for a short time. • How is it metabolized by the body?
- They’re not a required part of testing a • What's the highest dose that is
new drug. tolerable to patients?
Phase I ● Phase II
- This phase consists of short-term - Conducted on a larger group of people
clinical tests of the drug on 20 to 80 to further evaluate the safety of the
healthy volunteers to determine basic treatment and to determine how well it
pharmacological and toxicological works.
information in humans especially as - Typically the drug is tested in 100 to 300
regards safety. The FDA can stop patients.
clinical testing if they deem the drug - Dosage levels are experimented with to
unsafe. find optimal dosage levels, and further
- Studies that are usually conducted with information on safety is collected
healthy volunteers and that emphasize - The main purpose of a Phase II clinical
safety. trial is to begin to assess whether a drug
- The goal is to find out what the drug's is effective while exposing as few
most frequent and serious adverse people as possible to any unwanted
events are and, often, how the drug is side effects.
metabolized and excreted. - All study participants will have been
- The aims of this initial trial include: diagnosed with the condition that the
- Determining that the drug is safe for new medication has been designed to
humans treat.
- Gaining information about proper ● Phase III
dosage amounts - Designed to provide proof of the drug's
- Assessing side effects at different effectiveness in treating the target
dosage amounts health problem and to assess the risk
- Determining how the drug is vs. benefits of using the drug
metabolized by the human body - Drug is given to large groups of people
- Assessing the effect of the drug on often numbering in the thousands (1,000
target symptoms to 3,000)
Perspectives in Pharmacy

- Data is gathered regarding side effects - Double-blind studies are conducted to


and optimal dosage amounts in order to prevent bias on the part of the
provide labeling and physician researchers and the participants.
prescription information - Any effects seen as a result of taking
- Trials are tightly controlled and can take the placebo are usually attributed to the
several months to several years to expectations of the patient is known as
complete the "placebo effect."
- Done to determine if the new treatment ● New Drug Application (NDA)
is more effective, or has less side - The NDA application is the vehicle
effects, than the standard (currently through which drug sponsors formally
approved) method. propose that the FDA approve a new
- This phase answers the question "does pharmaceutical product for sale and
it work better than the standard marketing.
treatment?" - The data gathered during the animal
- Controlled clinical trial is a type of studies (preclinical) and human clinical
treatment research study in which a trials of an Investigational New Drug
treatment is compared to a control become part of the NDA.
group. This control group may be either - The goals of the NDA are to provide
another active treatment (e.g., another enough information to permit the FDA
medication), a non-active treatment reviewer to reach the following key
(e.g., a placebo), or some other type of decisions:
control group. • Whether the drug is safe and effective
- In some forms of research, a control in its proposed use(s), and whether the
group is used to provide a basis of benefits of the drug outweigh the risks.
comparison to the group of individuals • Whether the drug's proposed labeling
who are being studied in support of the (package insert) is appropriate, and
research theory what it should contain.
- A placebo is a substance given to a • Whether the methods used in
study participant that has no known manufacturing the drug and the controls
treatment value. used to maintain the drug's quality are
- Placebos are made as similar to the adequate to preserve the drug's identity,
actual treatment as possible. If the new strength, quality, and purity.
medication being studied is in the form - The documentation required in an NDA
of an injection, the placebo will be an is supposed to tell the drug's whole
injection. The idea is that the study story, including
participants and the researchers do not • what happened during the clinical
know who is getting the real treatment tests,
and who is getting a placebo. • what the ingredients of the drug are,
- Trials are typically conducted in a • the results of the animal studies,
"double-blind" manner, where neither • how the drug behaves in the body,
the researchers nor the participants • how it is manufactured, processed and
know who received the placebo and packaged
who received the medication. ● Abbreviated New Drug Application
- In this study, half of the participants (ANDA)
usually receive a placebo and the other - Contains data which when submitted
half get the actual medication of interest. to the provides for the review and
Perspectives in Pharmacy

ultimate approval of a generic drug of time as the innovator drug. -


product. bioequivalence
- Once approved, an applicant may ● Marketing Authorization (MA)
manufacture and market the generic ● Certificate of Product Registration
drug product to provide a safe, (CPR)
effective, low cost alternative to the ● Routine Commercial Production New
public. Product Launching Marketing
● 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