PHARMA-PRELIM
How many percent of efficacy is an antagonist?
0%
The process by which a drug enters or passes through the natural body barriers such as the skin, intestines, stomach, and blood-brain barrier and enters the bloodstream.
Absorption
What is the life cycle of a drug?
Absorption Distribution Metabolism Excretion/Elimination
These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.
Accelerated Approval
The effect of two chemicals is equal to the sum of the effect of the two chemicals taken separately. E.g., aspirin and Motrin
Additive effects
propensity of a drug to bind with a receptor. It is the strength of the interaction between a drug and the binding site of the receptor.
Affinity
What determines bioavailablity?
Age Diet Gender Interaction with other drugs Disease state
Factors affecting half-life: (4)
Age Renal excretion Liver metabolism Protein binding
this is when a chemical bind to a receptor and activates the receptor to produce a biological response.
Agonism
Serious allergic reaction causing itchy rash
Anaphylaxis
inhibits an enzyme from doing its job or blocks the action of the agonist. It slows down an enzymatically catalyzed reaction.
Antagonism
when the combination of drugs decreases the effects
Antagonism
Is naloxone full agonist, antagonist, partial agonist.
Antagonist
The effect of two chemicals taken together is less than the sum of their separate effect at the same doses
Antagonistic effects
It is the degree to which or proportion of the drug that is available to the site of action or target tissue to produce the desired effect.
Bioavailability
Engineers in this department link basic research with the commercial production of biologically derived products, such as antibiotics, natural products, proteins and vaccines.
Bioprocess Research and Development
A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
Breakthrough Therapy
It is a medicine that opens the airways of the lungs and used as asthma treatment.
Bronchodilator
Here engineers produce bulk pharmaceutical compounds used in safety assessment and clinical trials.
Chemical Engineering Research and Development
Evaluates a drug's chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.
Chemist
refers to studies, or trials, that are done in people.
Clinical research
The condition in which repeated administration of a drug may produce effects that are more pronounced than those produced by the first dose
Cumulative effects
To advances in chemistry, scientists can also create molecules from scratch. They can use sophisticated computer modeling to predict what type/s of molecule/s may work.
De novo
Major disruptor of drug metabolism
Depot binding
reduces bioavailability, slows elimination, can increase drug detection window and depot-bound drugs can be released during sudden weight loss.
Depot binding
At this stage in the process, thousands of compounds may be potential candidates for development as a medical treatment.
Discovery
is the movement of drug molecules through the bloodstream to the site of action.
Distribution
amount of drug required to produce the specific desired effect in an adult; usually expressed by weight or measure and a time factor (number of times per day)
Dosage
Generic drugs are comparable to brand name drugs and must have the same: (7)
Dosage form Safety Strength Quality Performance characteristics Intended use
Depicts the relation between drug dose and magnitude of drug effect
Dose-response curve
Find a promising molecule (a ―lead compound‖) that could become a drug
Drug discovery
an iterative process.
Drug discovery
A substance that alters biologic activity in a living being.
Drugs
Strengthening the support mechanism for the Philippine Drug Enforcement Agency.
EO No. 218
dose at which 50% population shows response
Effective Dose 50
the concentration of an agonist needed to elicit half of the maximum biological response of the agonist
Effective concentration 50
ability to produce a desired or intended results.
Efficacy
- is the removal of the drug from the body is usually associated with urination,
Excretion
offers several ways to help you stay informed about the medical products you prescribe, administer, or dispense every day.
FDA MedWatch
process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Fast Track
A constant fraction of drug is eliminated per unit of time.
First Order Kinetics
(metabolism of a significant amount of drug in the gut wall and the liver, before it reaches the systemic circulation).
First pass effect
The drugs absorbed from GI tract pass into the blood stream and the blood travels immediately to the liver.
First pass effect
Drug metabolism can be affected by: (6)
First pass effect Hepatic blood flow Age Gender Diet Concurrent diseases
Regulates the production, labeling, distribution, and other aspects of drug control
Food and Drug administration
unique official simple name for a specific drug; considered easy to remember accurately and used in many circumstances
Generic name
It is the time required to reduce the plasma concentration of a drug to half of its original value and is usually measured in hours.
Half life
is the measure of the extent to which a drug is removed by the liver from incoming blood.
Hepatic extraction ratio
A most common way that leads are usually found. Advances in robotics and computational power allow researchers to test hundreds of thousands of compounds against the target to identify any that might be promising.
High-throughput screening
negative effects on the body due to: wherein "you get sicker after getting treatment" • Medication error • Drug overdose • Unusual response
Iatrogenic
Unusual or unexpected reactions to drugs • Ex: excessive excitement after taking a sedative
Idiosyncratic
it happens outside of a living organism.
In vitro
It refers to work that's performed in a whole, living organism.
In vivo
For respiratory diseases, this route deposits drug close to the target organ; when used for systemic administration (e.g., nicotine in cigarettes, inhaled general anesthetics) it provides rapid absorption because of the large surface area available in the lungs.
Inhalation
Directly into the brain. into brain tissue into brain ventricles
Intracerebral Intracerebroventricular
Absorption is sometimes faster and more complete than after oral administration. Large volumes (e.g. 5 - 10 mL) may be given. Requires an injection. Generally, more painful than subcutaneous injection. Vaccines are usually administered by this route.
Intramuscular
a way to administer therapeutics and drugs through a peritoneal route (body cavity).
Intraperitoneal
Instantaneous and complete absorption (by definition, 100%); potentially more dangerous because the systemic circulation is transiently exposed to high drug concentrations.
Intravenous
(a model to explain ligand-receptor binding).
Law of Mass Action
a chemical compound that shows promise as a treatment for a disease and may lead to the development of a new drug.
Lead compound
dose at which 50% population dies
Lethal Dose 50
are non- ionized (no electrical charge) and it crosses pores, cell membranes and blood-brain barrier.
Lipid soluble drug
- a large first dose or first dose by injection to reach effective drug levels quickly
Loading dosage
is a gateway for reporting problems with medical products (drugs and devices) and learning about new safety information.
MedWatch
Reviews all clinical study information and data before, during, and after the trial is complete.
Medical Officer
monitors the safety and effectiveness of medical devices.
Medical Product Safety Network
is the process of biochemical modification or degradation of a drug in the body.
Metabolism
Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.
Microbiologist
a life-saving medication that can reverse an overdose from opioids
Naloxone
tells the full story of a drug. Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied.
New drug application
is available as a transdermal patch for those who are trying to stop cigarette smoking.
Nicotine
is administered by this route in the treatment of angina.
Nitroglycerin
Maximum convenience but may be slower and less complete than parenteral (non- oral) routes. Dissolution of solid formulations (e.g. tablets) must occur first.
Oral
Drugs than an individual can purchase without a "note" from their doctor • Still recommended that a doctor be consulted when there are other medical conditions or prescriptions being taken
Over the counter
Route other than ingestion where intravenous, intramuscular, and subcutaneous are categorized.
Parenteral
Is tramadol full agonist, antagonist, partial agonist
Partial agonist
an exclusive right that allows the inventor to exclude others from making, using, or selling the product of his invention during the life of the
Patent
are responsible for the discovery, development, and manufacture of these drugs and medicines by public and private organizations.
Pharmaceutical Industries
Engineers develop formulations and drug delivery systems for new products.
Pharmaceutical Research and Development
It supports the Pharmaceutical Manufacturing. Engineers provide technical support to enable technology transfer and address technical issues with local manufacturing groups.
Pharmaceutical Technology and Development
are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, where they also are involved in the conception, design, scale-up, manufacturing, and labeling and packaging processes in the conversion of chemical and biological materials into valuable pharmaceuticals and pharmaceutical therapies.
Pharmaceutical engineers
are medicines and drugs used for treating medical conditions.
Pharmaceuticals
It is the interaction of a drug and the receptors responsible for its action in the body.
Pharmacodynamics
Relates to studying the pattern of expression of gene products involved in a drug response
Pharmacogenetics
The range of major tests undertaken (9)
Pharmacokinetic profile Pharmacodynamic profile Bioequivalence and Bioavailability Acute toxicity Chronic toxicity Reproductive toxicity and teratogenicity Mutagenicity Carcinogenicity Immunotoxicity
The process by which a drug is absorbed, distributed, metabolized and eliminated in the body.
Pharmacokinetics
Branches of pharmacology (2)
Pharmacokinetics and Pharmacodynamics
Reviews preclinical studies.
Pharmacologist
It is a branch of biology and medicine that is concerned with the study of drug action. (from Carrington edu).
Pharmacology
the study of how a drug affects a biological system and how the body responds to the drug.
Pharmacology
Focuses on the drug's absorption, distribution, metabolism, and excretion processes. Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
Pharmakineticist
What is the greek word of pharmacology
Pharmakon
predict functional relationships
Phylogenetic profiling
It is given to a control group which lacks the active ingredient being tested in the study
Placebo
Relative strength of response for a given dose
Potency
Understand the disease
Pre-discovery
the "note" that the doctor writes that details the dosage and instructions
Prescription
means FDA's goal is to take action on an application within 6 months.
Priority review designation
Coordinates the team's activities throughout the review process, and is the primary contact for the sponsor.
Project Manager
FDA IND Review team (7)
Project Manager Medical Officer Statistician Pharmacologist Pharmakineticist Chemist Microbiologist
Drugs may be prescribed to: (7)
Promote healing Cure disease Slow or control progression of disease Prevent disease Increase comfort level Reduce excessive activity into the body Decrease risk of complications
a trademark name assigned by a single manufacturer and to be used only by that manufacturer
Proprietary name or Brand name
An Act Institutionalizing the Philippine National Health Research System
RA 10532
Amending For The Purpose Section 21 Of Republic Act No. 9165, Otherwise Known As The "Comprehensive Dangerous Drugs Act Of 2002′′
RA 10640
An act promulgating a comprehensive policy in addressing the needs of person with rare disease.
RA 10747
The Medical Act of 1959.
RA 2382
An Act Regulating The Practice Of Pharmacy And Settings Standards Of Pharmaceutical Education In The Philippines And Of Other Purposes.
RA 5921
"The Dangerous Drugs Act Of 1972".
RA 6425
An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names.
RA 6675 :Generics Act of 1988
An Act Prohibiting Counterfeit Drugs,Providing Penalties for Violations and Appropriating Funds Therefor.
RA 8203
An Act Instituting The Comprehensive Dangerous Drugs Act Of 2002, Repealing Republic Act No. 6425, Otherwise Known As The Dangerous Drugs Act Of 1972, As Amended, Providing Funds Therefor, And For Other Purposes.
RA 9165
An Act Providing for Cheaper and Quality Medicines, Amending for the Purpose Republic Act No. 8293 or The Intellectual Property Code, Republic Act No. 6675 or the The Generics Act of 1988, and Republic Act No. 5921 or The Pharmacy Law and for Other Purposes
RA 9502
Target/site of drug action
Receptor
Same advantage as sublingual route; larger amounts are feasible. Useful for patients who cannot take oral medications (e.g. because of nausea and vomiting).
Rectal
study of amino acids
Rosetta Stone Method
specific affinity for certain receptors vs. others.
Selectivity
the FDA's national electronic system which has transformed the way researchers monitor the safety of FDA- regulated medical products, including drugs, vaccines, biologics, and medical devices.
Sentinel
degree of similarity between sequences
Sequence homology studies
It is the ability of a drug to combine with a particular type of receptor.
Specificity
Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.
Statistician
Slower absorption than intramuscular. Large volumes are not feasible. Requires an injection. Insulin is administered by this route.
Subcutaneous
Permits direct absorption into the systemic venous circulation thus avoiding the first pass effect. May be fast or slow depending on the physical formulation of the product. Nitroglycerin is administered by this route in the treatment of angina.
Sublingual
when the combination increases the effects of what has been taken; can be life threatening
Synergism
The effect of two chemicals taken together is greater than the sum of their separate effect at the same doses. Eg. Alcohol and other drugs
Synergistic effects
Choose a molecule to target with a drug
Target indetification
harmful effects on the fetus leading to developmental defects
Teratogenic
Test the target and confirm its role in the disease
Test validation
The ratio between plasma concentration that produces desired effect
Therapeutic Index
an indication of safety of a drug
Therapeutic Index
Application to the skin or mucous membrane of the nose, throat, airway, or vagina for a local effect.
Topical
refer to both drugs used in the treatment of disease and with chemicals that may be present in household, environmental, or industrial hazards.
Toxicology
is a strong painkiller from a group of medicines called opiates,
Tramadol
Application to the skin for systemic effect. Generally are patches that stick to the skin and are worn for a number of hours or even days.
Transdermal
the tolerance/sensitivity at the cellular level may be due to a change in number of receptors (without the appropriate subunit) due to changes in stimulation.
Up/down regulation
is ionized (have an electrical charge) and it can cross through pores in capillaries but not cell membranes
Water soluble drug
Constant amount eliminated per unit time.
Zero Order Kinetics
is a natural system that functions to keep harmful chemicals from entering the cerebrospinal fluid from the blood.
blood brain barrier
The most important rate-limiting factor for distribution of a drug
blood flow
The resulting drug is the
candidate drug
Drugs bind to
depot sites or silent receptors
accurately and objectively describes the basis for approval and how best to use the drug.
labeling
pharmakon means in classic greek
poison
These trials follow a specific study plan, called
protocol
A clinical hold is
rare
as lock
receptor
the increased effectiveness with repeated administration or less drugs is needed to achieve the same effect.
sensitization
Basic principles in Pharmacology (5)
study of drugs action dosage therapeutic uses adverse effects
decreased effectiveness of a given drug with repeated administration or more drug is needed to achieve the same effect
tolerance
How many percent of efficacy is a partial agonist?
50%
FDA responds to IND applications in one of two ways:
1. Approval to begin trials 2. Clinical hold to delay or stop the investigation
Types of Pharmaceutical Engineers
1. Pharmaceutical Research and Development 2. Pharmaceutical Technology and Engineering 3. Chemical Engineering Research and Development 4. Bioprocess Research and Development
How many percent of efficacy is a full agonist?
100%
How many percent of efficacy is an inverse agonist?
100%
Example: A patient is taking a drug and has a toxic blood level of 16mg/L. How long will it take for the blood level to fall to 2mg/L if the half life of the drug is 8hrs?
24 hours
Preclinical research can take up how many years to complete
3 years
FDA review team has how many days to review the original IND submission
30 days
FDA recruits how many healthcare providers throughout the United States to report any medical device problems that result in serious injury or death.
350
A chemical substance capable of combining with a specific receptor on a cell and initiating the same reaction or activity typically produced by the binding endogenous substances.
agonist
indicates the pH where 50% of the drug is ionized (water soluble) and 50% non-ionized. This affects the drug's solubility, permeability, binding and other characteristics.
dissociation constant
acts as key
drug
pharmakon means in modern greek
drug
transforms drugs into more water- soluble metabolites so that it can eventually excreted by the kidneys.
enzyme (cytochrome P-450)
the genes that encode the metabolic pathways
gene neighborhood method
the best source of information about the right medicines for you.
healthcare provider
