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Phar 122 > Module 1 - Drug Development > Flashcards

Module 1 - Drug Development Flashcards

1
Q

What is a disease

A

Interferes with normal state, causes abnormal function of system, part, or organ.

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2
Q

What is a disease defined by?

A

-Recognition of etiologic agents
-identifiable signs and symptoms
-consistent anatomical alterations

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3
Q

Aetiology

A

Genes play into disease, environment can turn a gene on

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4
Q

Drug

A

Agent for diagnosis, treatment, cure, or prevention

A poison

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5
Q

Lead Compound

A

Prototype for fundamental and desired activity of drug
may not yet posses all desired features

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6
Q

Prodrug and why we use it

A

-Metabolically transformed after administration to be activated.
-Controlled release, targeting, stability, distribution, optimal solubility, permeability (in gut), extended effects

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7
Q

Dosage Form and uses for altering drug forms

A

How a drug is prepared for patient and its delivery system
-can reduce toxicity, conceal taste/smell, patient convenience, accurate administration, decomposition protection.

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8
Q

When is chemical name given to a drug

A

At initial discovery with its empirical formula

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9
Q

When is generic/nonproprietary name given?

A

When drug shows promise

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10
Q

When is proprietary/brand name given

A

When developed and marketed

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11
Q

Pharmaceutics

A

Formulation and drug manufacture
-physical, chemical, and biological factors that influence the stability and effectiveness. Considered during formulation and manufacturing

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12
Q

Biopharmaceutics

A

Study of drug properties and dosage form after administration
-involves pharmacokinetics (absorption, distribution, metabolism, and excretion)

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13
Q

What is Pharmacokinetics concerned with?

A

What the body does to a drug

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14
Q

What is considered a new drug?

A

Drug not recognized as safe and effective, new chemical entity

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15
Q

What are the three American Drug Regulators?

A

Food, Drug and Cosmetic Act
Food and Drug Administration (FDA)
New Drug Application (NDA)

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16
Q

What are the three Canadian drug regulators?

A

Food and Drug Act
Health Canada
New Drug Submission (NDS)

17
Q

How long is the drug discovery process, how many make it to human testing, what is the total cost of a new drug?

A

10-12 years, 5/10,000 drugs, 2.6 billion

18
Q

What are the first two processes of drug discovery that take 2-6 years. How many drugs are in this process?

A

Discovery and preclinical trials. 5000-10000 in discovery and 250 in preclinical.

19
Q

What are the three phases of clinical trials? how many participants are included in each phase?

A

Phase 1: 20-100 participants. Checks safety profile and microkinetics.
Phase 2: 100-500 participants. Finding correct dose and finding efficacy.
Phase 3: 1000-5000 participants. Test safety and efficacy on a larger scale

20
Q

What form is submitted before clinical trials

A

Investigational new drug form (IND)

21
Q

What form is submitted after clinical trials?

A

New drug Application Form (NDA)

22
Q

What two processes occur after clinical trials?

A

FDA review then scale up to MFG (0.5-2 years)

23
Q

When does the formulation process occur?

A

During pre-clinical trials

24
Q

What is treatment requested by a physician that is not approved yet?

A

Special access programme (SAP)

25
Q

What does NDS stand for

A

New Drug Submission

26
Q

What is the role of CADTH

A

Economic decisions for affordability.

27
Q

What is PMPRB

A

Patented Medicine Price Review Board. Regulates medication price to ensure access is possible

28
Q

Why do biologics take longer to approve?

A

High complexity and finding an expert that can review it

29
Q

What does postmarketing look for

A

-Removal if new side effects arise that were absent in lab
-Watch for indication of possible new drug
-Phase 4 clinical adverse reaction report

30
Q

What are some methods of Patent Protection

A

Superior clinical formulations
New administration routes
Chiral switching
More than one usage

31
Q

Innovator Product

A

Brand name developed by innovator of first product

32
Q

Generic Product (what application form is needed?)

A

Copy of brand name when patent is expired
Abbreviated New Drug Application

33
Q

Bioequivalence

A

Seemingly equivalent products may vary due to formulation and manufacturing. Use dissolution testing to ensure new drug is equivalent to original patent.

34
Q

What information is sought during post-marketing surveillance

A

Adverse reaction, defect reporting, product line extension-modified version

35
Q

Where does a drug interfere?

A

Symptoms & Disabilities. Controls/stops them.

36
Q

Diagnosis drug example

A

Radioactive bio markers for cancer diagnosis

37
Q

Prognosis drug example.

A

Inhaler for asthma. Controls prognosis and prevents from getting worse

38
Q

What happens if is drug is given to a healthy individual?

A

Interacts with biological processes and causes side effects. Even if it’s a benign drug it is still a poison.

39
Q

Drug Product

A

Preparation/formulation of a drug
Has: active ingredient, additives, dosage form, method of preparation

Phar 122 (1 decks)

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