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Manufacturing/Distribution for OTC/Rx drugs

What is the Pharmaceutical Industry?

Merck, Pfizer, Astra-Zeneca

What are some examples of "Big Pharma" companies?

New Drugs through the NDA

What do "Big Pharma" companies produce?

New Drug Application

What does NDA stand for?

1. Determine whether a drug is safe/effective.

2. Drug package insert is appropriate.

3. Whether the methods used in manufacturing the drug are adequate to preserve the drug's identity, strength, quality, and purity.

What are the goals of NDA?

Barr, Mylan, Ivax, Abraxis

What are the generic companies?

Generic equivalents through ANDA

What to the generic companies produce?

Abbreviated New Drug Application

What does ANDA stand for?

Contains data for the review and ultimate approval of a generic drug product.

What is the purpose for ANDA?

Cubist, Teva, Sandoz

What are the "small pharma" and blended companies?

Exclusive and generic products through NDA and/or ANDA

What do "small pharma" offer"

Amgen and Genentech

What are the biotechnology companies?

High tech/biotech drugs (primarily large molecules)

What do biotech companies offer?

Shire, Andrix, King

What are the "specialty pharma" companies?

Old drugs with new spins (Combinations, SR)

What do specialty pharma companies offer?

Provides support to the pharmaceutical/biotechnology industries in the form of outsourced pharmaceutical research services.

What are CRO's?

PPD, Covance, Quintiles

What are examples of CRO's?

Cardinal Health, Eurand

What are contract manufactures and development?

Smith Drug, McKesson

What are the drug wholesales?

FDA and FTC (Federal Trade Commission)

What are regulatory agencies/bodies?

Two years

How many years is the preclinical testing?

Laboratory and Animal Studies

What is the test population in the preclinical testing?

Assess safety and biological activity

What is the purpose of the preclinical testing?

preclinical testing and phase I

After the ________and before phase____ the IND is filed.

One year

How long is PHASE I?

20-80 health volunteers

What is the test population in PHASE I?

Determine safety and dosage

What is the purpose of PHASE I?

70% of INDs. (Investigational New Drug)

What is the percentage of all new drugs that pass in PHASE I?

Two years.

How many years is PHASE II?

100-300 patient volunteers

What is the test population is PHASE II?

Evaluate the effectiveness, look for side effects.

What is the purpose of Phase II?

Phase II and Phase III

_______ and ________ are combined to shorten approval process on new medicines for serious and life-threatening diseases.


________% of all new drugs that pass in PHASE II.


Phase III takes _____ years to complete.

1000-3000 patient volunteers

What is the test population in PHASE III?

Verifying effectiveness monitor adverse reactions from long-term use.

What is the purpose of PHASE III?


______% of all new drugs that pass in PHASE III.

Phase III and Phase IIIb

After phase_____ and before phase _____ the NDA is filed.


A _________ group is used to file the new drug application.

2 years

How many years in PHASE IIIb?

1,000-10,000 patient volunteers

What is the test population in PHASE IIIb?

2-3 years of review and expanded compassionate use.

What is the purpose of PHASE IIIb?


______% of all new drugs that pass Phase IIIb.

Phase IIIb and Phase IV

After phase_____ and before phase _____ is the drug FDA approved.

Phase IV

In phase_____ the test population includes post marketing and safety monitoring.

Large scale manufacturing, Distribution and Education.

The purpose of phase IV is ________, ________, and ______


______ is a intravitreal drug implant for the treatment of chronic non-infectious Uveitis.

Patent extension. (for up to 5 years for time lost in "review")

The drug price competition and patent term restoration act provides ________.

20 years

USPTO (US patent and trademark office) changed the patent term from 17 years to _______

Pediatric Exclusivity

The 6 month marketing exclusivity was extended to the first company that conducted the clinical studies and obtained FDA approval for the pediatric
indication is called _________.

Generics (first to file) Exclusivity

6 months exclusivity to first to file if you win and is the patent litigation occurs is called____________.

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