Introduction to Pharma

59

record of FDA approvals of novel drugs during 2018

37

record of FDA approvals of novel drugs during 2022

12 years or longer

estimation of years for developing a drug

informed consent

is based on principles established by the 1947 Nuremberg code

1947 Nuremberg Code

its principles are what informed consent is based on

Beneficence

is the ethical duty to protect research participants from harm and promote their well-being

Risk-benefit ratio

compares the possible harms of a study with its expected benefits

Institutional review boards (IRBS)

must determine whether the risk are reasonable in relation to the expected benefits

Justice

requires fairness in the selection and treatment of research participants

Preclinical Trials

-conducted before testing a drug in humans

-The FDA requires these studies to evaluate a drug’s safety and pharmacologic effects in laboratory settings

Vitro testing, vivo testing

Testing methods

Toxicity

Potential harmful or poisonous effects

Pharmacological effects

How the drug affects biological functions

Genotoxocity

whether the drug can damage genetic material within cells

Human clinical experimentation

evaluates the safety and effectiveness of new drugs in people

vitro testing

studies conducted using cells, tissues, or other laboratory systems outside a living organism

vivo testing

studies performed in living animals to observe the drug’s effects on the whole body

NIH Revitalization Act of 1993

promoted the inclusion of women and minorities in clinical research

Best Pharmaceuticals for Children Act of 2002 and Pediatric Research Equity Act of 2003

encouraged drug studies involving children

phase 1

tests a drug in a small group for the first time, evaluates safety, identifies side effects, and determines a safe dosage range

phase 2

Tests the drug in a larger group, evaluates its effectiveness and continues monitoring safety

phase 3

Involves large groups, confirms effectiveness and monitors adverse effects

phase 4

conducted after marketing, evaluates long-term effects

independent, dependent, intervening variable/s

study variables for clinical research

independent variable

factor changed by the researcher

dependent variable

the measured outcome, such as the patient’s clinical response

intervening or extraneous variables

factors that may affect the outcome

Experimental group, Control group

Study groups

Experimental group

receives the drug or treatment being investigated

control group

provides a basis for comparison

USP-NF

the authoritative source of standards for drugs, dosage forms and etc…

WHO’s International Pharmacopoeia 1951

Provides worldwide standards for drugs strength and composition

Philippine Pharmacopoeia 2004 (Executive Order No.302)

is the official reference for the identity, purity and quality of pharmaceutical products and crude plant drugs

Japanese, British, European or International Pharmacopoeia

can be used as an alternative if products are not listed in the Philippine Pharmacopoeia

Philippine FDA (Republic Act No. 9711)

regulates health products and develops standards to ensure their safety, efficacy, quality and purity.

Federal drug legislation

-protects the public from medicines that are impure, toxic, ineffective, mislabeled or insufficiently tested

-its primary purpose is to ensure medication safety and quality before public sale

Food and Drug Administration Act of 1906

-first major U.S law regulating drugs

-did not require manufacturers to prove the drugs were safe or effective before marketing

Heroin, LSD, cannabis, ecstasy

No currently accepted U.S medical use

Fentanyl, cocaine, methamphetamine, oxycodone

accepted medical use

Ketamine, testosterone, anabolic steroids,

moderate-to-low dependence potential

Alprazolam, diazepam, lorazepam, tromadol

Low misuse and dependence potential

low-codeine cough preparations, pregabalin

lowest misuse potential

N- acetyl-para-acetaminophenol

paracetamol chemical name

cetal, adol, abimol

paracetamol trade names

OTC medicines

can be purchased without a prescription and are considered appropriate for self-care when used exactly as directed

pain relievers, cold remedies, antihistamines, antacids, laxatives, sleep aids, supplements and topical treatment

common examples of OTC drugs

NSAIDS such as ibuprofen and naproxen

may increase the risk of stomach bleeding, kidney injury, fluid retention, heart attach, and stroke

(Excessive) acetaminophen

can cause severe liver injury

Aspirin

should not be given to children or teenager with viral infections of the risk of Reye syndrome