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