PHARMA UNIT 5

RANDOM SCREENING

This is what is commonly employed in our institution wherein we extract an active constituent from a plant or animal or other natural sources and is tested for their therapeutic activity.

CHEMICAL MODIFICATION OF A KNOWN ACTIVE MOLECULE

Chemical modification of a known active molecule, resulting in a “me-too” analog

RATIONAL DRUG DESIGNING

Rational design of a new molecule based on an understanding

MOLECULAR LEVEL

The potential drug is tested into a cell or a homologous animal receptor and try to find out its affinity. The compound would be screened for activity on the target.

CELLULAR LEVEL

It answers “What would be its effect into the cell.”

WHOLE ANIMAL LEVEL

Generally necessary to determine the effect of the drug on organ system models and disease models

in vitro

This phase is called ___because we are testing it in models or in test tubes.

Natural history of disease

according to CDC, refers to the progression of the disease process in an individual over time in the absence of treatment.

“The Food and Drug Administration Act of 2009”

The agency is responsible for licensing, monitoring, and regulation of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines for safety efficacy and quality in the Republic of the Philippines.

Clinical trials.

Chronic safety testing in animals is usually done concurrently with what

PHASE I

Effects of the drug as a function of dosage (safe clinical dosage range)

PHASE II

This phase answers the question: Would the drug really treat the target disease in a human being?

PHASE III

This is done to minimize errors caused by placebo effects, variable course of the disease, and other factors.

New Drug Application (NDA)

If the drug passes in all the phases of the clinical trials, the drug sponsor or manufacturer will now apply for what

NEW DRUG APPLICATION

Phase 3 results meet expectations, application is made for permission to market the new agent.

PHASE IV

What phase is POSTMARKETING SURVEILLANCE

Orphan drugs

Drugs for rare diseases are called

1,000–6,000 patients

Phase III clinical trials usually involve:

Double-blind

Which study design helps reduce observer bias?

20 years

According to the notes, the lifetime of a drug patent in the USA and the Philippines is:

20-100

Approximately how many healthy volunteers participate in Phase I clinical trials?

Phase II

Which phase has the highest rate of drug failure?

Rare adverse effects may not be detected.

Which of the following is a limitation of preclinical testing?

Lead compound

The successful candidate selected after drug screening is called the

Animal testing

Which phase comes immediately after in vitro studies in drug development?