· defined as an agent intended for use in the diagnosis , mitigation, treatment, cure or prevention of disease in humans or in other animals.

facilitates examination usually to arrive into a conclusion or diagnosis,

lessens the symptoms and the effect of the disease but the disease is still there.

patient has no longer the disease.

prevents illness or disease from occurring

It is drugs that are naturally occurring biological products. It is made or taken from a single cell organism, like plants, animals, or human.

It is created artificially to exert pharmacological effect.

It is a drug that are created in the laboratory but in imitation of naturally occurring drug.

contains both synthetic and natural modification

Extracts, do have active/second metabolise

Insulin, first was taken from a pig but due to adverse reaction. Heparine, from fish. Bees wax, form animals etc..

ex. chloramphenicol/penicillin/Vitamin B12/streptomycin

Made from chemicals which then have modifications to have a specific pharmacological effect.

Either semi-synthetic, synthesized, synthetic

Can be done through: Biotechnology, Genetic engineering

Drugs that can be dispensed without the need of prescriptions.

Drugs that can be dispensed with the need of prescriptions.

biochemically reactive component of the drug, causes therapeutic activity, rarely given in pure (undiluted or uncut form, instead they are always given in 1 or more inert ingredients “inactive ingredient”- to dilute the pure and stabilize drug product

purpose is to stabilize the drug product

· Formulation containing a specific quantity of active ingredient(s) in combination with one or more excipients.

· Refers to the physical manifestation of a drug that can be used in a way

Tablet, Capsule, beads/pellets, powder, granules, strepsil, implant, lozenges, and medical lollipops

Syrup, drops, suspension, elixirs, solutions, gargles, mouthwash, emulsion, and pincture.

Example: Gel, cream, ointments, pastes, suppositories, transdermal, lotions, plasters, magma-preparational

Transporting a drug to its site of action within the body.

Device used to deliver the drug. Design feature of the dosage form that affects the delivery of the drug

An organized set of monographs or books that contains information to standardized drugs.

adopts standards for drug substances, pharmaceutical ingredients, and dosage forms reflecting the best in the current practices of medicine and pharmacy and provide suitable tests and assay procedures for demonstrating compliance with these standards.

Regulated food and drugs moving in interstate commerce and forbade the manufacture, sale, or transportation of poisonous patent medicines.

Created because of the tragedy with the new drug sulphanilamide

Equivalent Law= in Ph. of Federal Food, Drug And Cosmetic Act of 1938 (also created by the FDA)

Law created by RA.3720

To establish a legal act about OTC and Prescription drugs. Distinguish OTC and prescription drug

Thalidomide Tragedy caused this Amendment, require the manufacturer is both safe and effective before it will be approved the FDA.

serves to consolidate and codify control authority over drugs of abuse, establish 5 schedule for the classification that are subject for the substance of abuse, Serves to combat illegal drug use

Equivalent Law of Comprehensive Drug Abuse Prevention and Control Act of 1970 in PH

Drugs with no accepted medical use or other substances with a high potential for abuse.

Drugs with accepted medical uses and a high potential for abuse that if abuse may lead to severe psychologic or physical dependence.

Drugs with accepted medical uses and a high potential for abuse that if abuse may lead to severe psychologic or physical dependence.

Drugs with accepted medical uses and low potential for abuse relative to those in Schedule III that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule III

Drugs with accepted medical uses and low potential for abuse relative to those in schedule IV that if abused may lead to limited physical dependence or physiologic dependence relative to schedule IV.

Adequate, well- controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.

Animal studies have revealed no evidence of harm to the fetus: however, there are no adequate and well-controlled studies in pregnant women, OR Animal studies have shown an adverse effect, but adequate and well- controlled studies in pregnant women have failed to demonstrate a risk to the fetus.

Animal studies have shown adverse effect and there are no adequate and well-controlled studies in pregnant women, OR No animal studies have been conducted and there are no adequate and well- controlled studies in pregnant women.

Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.

Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant

To let customers be aware of adverse effects or may be used to communicate important instructions for safe use of the drug

Amended the Federal Food, Drug, and Cosmetic Act so that drug establishments that are engaged in the manufacturing, preparation, propagation, compounding, or processing of a drug are required to register their establishments and list all of their commercially marketed drug products

Patency of drug products

è Defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices.

There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

The use of or exposure may cause temporary or medically reversible adverse health consequences or probability of serious adverse health consequences.

Use of or exposure to a violative product is not likely to cause adverse health consequences.

Any drug that is not recognize as being safe and effective in the conditions recommended for its use In the labelling among experts who are qualified by scientific training and experience.

New Chemical Entity

Preclinical Studies

All the information obtained is written in

All the information obtained is written in

Is used to gain approval to market a duplicate of a product that is already approved and being marketed by the pioneer, or the original sponsor, of the drug.

Is filed or submitted for approval ¡f certain changes in a previously approved NDA, such as labeling or a formulation changes.

A chemical alteration of a known and previously characterized organic compound (LEAD COMPOUND) for the purpose of enhancing its usefulness as a drug.

A molecular modification to design a drug that interferes specifically with the known or suspected biochemical pathway or mechanism of a disease process.

· Is a prototype chemical compound that has fundamental desires biologic or pharmacologic activity

Is term used to describe a compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound.

Advantages over the active drug because it enables the use of specifically desired dosage form and route of administration

Drug may be made more water or lipids soluble as desire to facilitate absorption via the intended route of administration.

If the active drug prematurely destroyed by the biochemical the design of prodrug may protect the drug during its transport in the body

Is the science concerned with drugs, their sources, appearance, chemistry actions and uses

the study of the biochemical and physiologic effects of drugs and their mechanisms of action.

deals with absorption, distribution, metabolism, excretion (ADMFJ.

These studies are designed to determine the toxic effects of a test compound when administered in a single dose or multiple doses over a short period of time in a single day (usually).

These studies is done in a minimum of 2 weeks of daily drug administration at three or more dosage levels to two animal species are required to support the initial administration of a single dose in human clinical testing.

· Usually a component of chronic testing and is undertaken when the compound has shown promise as a drug to human trials.

· Are undertaken to reveal any effect of an active ingredient on mammalian reproduction.

Are performed to determine whether the test compound can affect the gene mutation.

· Objective: Assessing safety

· Subject: Healthy human volunteer

· Outcome: Determine the human pharmacology of the drug, SAR (Structural Activity Relationship), side effects associated with increasing doses and if possible early evidence of effectiveness.

Objective:

Controlled clinical studies to evaluate the effectiveness of a drug in patients with the condition for which the drug is intended

Subject : Informed patients

· Objective: Determine the usefulness of the drug in an expanded patient base.

· Subject: Several hundred to thousands patients in controlled and uncontrolled trials.

· Often called: Post marketing surveillance trials

Objectives:

a. Comparison of the drug with the drugs already marketed

b. Monitoring of tong-term effectiveness & impact on patient’s quality of life

C. Determination of the cost-effectiveness of a drug therapy

Subjects:

General consumers

regulations establish requirements for all aspects of pharmaceutical manufacture

Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form.

It is an active ingredient, that can provide a pharmacologic activity, any ingredient that is intended to furnish pharmacologic activity

A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture

Produced from a single order within the same cycle of production and it is a specific quantity of drug

The use of validated in-process sampling and testing methods in such a way that results prove that the process has done correctly

While the product is being produced mag pick ang quality asurance pharmacist ug samples while in process and product

Purpose: para di tanan na produce niya ayha pa siya e test, di ma sayang if ma fail

Prevent ang ma sayang na product

Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable.

Manufacturer is acting in accordance with prescribed regulations, standards and practices.

Any ingredients used in the manufacture of drug, including those that may not be present in the finished product.

Any ingredient (active or inactive)

A finished dosage that contains an active drug and inactive ingredient

May also include a form that does not contain an API like placebo drug

Any component other than the active ingredients in the drug product

Also called as Inert Ingredient or pharmaceutical necessity/ pharmaceutical adjuvant/ pharmaceutical excipients

A batch or a portion of a batch having uniform specified quality and a distinctive identifying lot number

Distinctive combination of letters, numbers or symbols from which the complete history of the manufacture, processing, labeling, distribution of a batch may be determined.

for easy identification and traceability of errors with the same batch number, for the product recall.

Containing the formulation, specifications, manufacturing procedures, quality assurance requirements and labeling of a finished product.

Wide-ranging concept covering all matters that individually or collective influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.

A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality.

Is part of GMP concerned with sampling, specifications, and testing and with the organization, documentation, and release procedures which ensures that the necessary and relevant tests are carried out.

An organizational unit independent of production which fullfills both quality assurance (QA) and quality control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization

Termed for the Quality Assurance, Quality Audit, and Quality Control

An area that is marked, designated or set aside for the holding of incoming components prior to acceptance testing and qualification for use.

Raw materials are under quarantine

Sticker approved. Passed QC/QA

Not meet the quality standard

Representative sample of the whole product.

The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process.

Concentration of the drug substance per unit dose or volume

Signed by a second individual or recorder by automated equipment

Documented evidence that a system and process does what it purports to do.

Essential to ensure that the consumer receives products of quality

Integral part of the pharmacy practice and essential to the provision of the healthcare

The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery, device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder relationship in the course of professional practice.

Is the production, preparation, propagation, conversion, and/or processing of a drug or device, either directly or indirectly, through extraction from substances of natural origin or independently through means of chemical or biological synthesis

from drug development to the production and packaging of the drug product

already have the raw materials (active and inactive ingredients) kita na bahala compound manually

preparation of drugs or devices is in anticipation of prescription drug order.

The preparations and promotions of commercially available product from bulk compounds for resale for pharmacist

direct sa patients

Di direct sa pharmacist, sa mga pharmacy, hospital pharmacy or other practitioner ayha pa mo reach sa patient or consumer

Large scale production of the drug product that is based on the manufacturing order or schedule of production and it is for the general consumers

It is a small scale preparation of drug product, it is a prescription based order/ prescription order or for the specific/ particular patient

It is the direct contact with the drug

Container

that which is in direct contact with the article at all times

encloses the primary container

encloses the secondary container

Example, blister packs, bottles,

Examples, Unit box or folding cartons, Box of the blister packs,

Purpose: for market presentation

Big box/ Corrugated box

Classification of Containers

Well-closed container

Tight container

Hermetic container

Single-unit

Mulitiple-unit

Glass

Plastic

Foils, Laminates and Films

Rubbers

Metallic

Child-resistant container

Tamper-resistant container

It protects the contents from the extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage and distribution.

Protects the contents from contamination by extraneous liquids, solid, or vapors, from loss of the article and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution and is capable of tight re-closure.

Commonly packed in tight container

- Efflorescence

- Deliquescence

- Hydroscopic

mag absorb ug moisture pero di siya ma dissolve or melt.

pag mag absorb ug moisture ma siya or ma melt.

releases water of crystallization so dapat protected siya from liquid as well as vapor.

Is impervious to air or any other gas under ordinary or customary conditions of handling, shipment, storage and distribution

Protects the contents from photochemical deterioration

Holds quantity of drug intended as a single dose and when opened, cannot be resealed with assurance that sterility has been maintained

Hermetic container that permits withdrawal of successive portions of the contents without changing the strength or endangering the quality and purity of remaining portion

Highly resistant borosilicate glass. Contains BORIC OXIDE for buffer and non-buffered aqueous solution. Preferred glass type for laboratory use

Treated soda lime glass. Treated with S02. Contains high level of NaOH and CaO used for water attack test

For oily solutions and dry powders. Not resistant to high temperature thus cannot be autoclaved.

movement of the component of the container padung sa content, part of the container mo padulong kay drug

container to drug movement of content

container to drug

Binding of molecules to polymer materials

-Content of the drug mo dikit kay container.

Ma kuhaon ug quantity si drug product kay ni absorbs container.

-drug to container

2 process: Absoption or adsorption

Does not apply to single material but rather to a vast number of materials each developed to have desired features.

ma squeeze, ex. Cellophane, nebule container, mineral bottle

firm and rigid, ex.

Advantages

Disadvantages

Process of solution and diffusion, ma penetrate ang mga dissolce product sa plastic

Polyethylene

Polypropylene

Polyethylene terephthalate

Polyvinyl chloride

Polyesterene