Lecture 1

Question 1

Dosage Forms

Answer 1

• Physical form of a dose of medication (i.e. capsule or injection)
• Drug added to a dosage form to formulate a usable product.

Question 2

Delivery Systems

Answer 2

• Used to carry, distribute or transport drugs into and throughout the body
• Goal: to increase patient compliance and to enhance drug efficacy and tolerance

Question 3

Bioprospecting

Answer 3

“To search for substances that are produced by living organisms and may be of medicinal or commercial value”

• Early dosage forms originated from bioprospecting, the collection and testing of biological samples.
- Still exists

Question 4

Early Drug Products

Answer 4

• Most were based on Botanical Products, or Mineral products such as Chinese Traditional Medicines

Question 5

Drug Standards

Answer 5

• By law in the US, all prescription and OTC medicines must meet USP standards.
• The FDA is responsible for regulating drug products in the US.

Question 6

GXPs

Answer 6

• GMP–Good manufacturing practice
• GLP–Good laboratory practice
• GCP–Good compounding practice

Question 7

Drug Approval Process (US) IND

Answer 7

• Investigational New Drug
• How a company gets permission to ship an experimental drug across state lines before a marketing application has been approved.
• IND must cover three broad areas:
- Animal Pharm. and Toxicology Studies
- Chemistry and Manufacturing Info
- Clinical Protocols and Investigator Info

Question 8

Drug Approval Process (US) NDA

Answer 8

• New Drug Application
• Formal proposal that FDA approve a new pharmaceutical for sale and marketing.
• Want to show FDA that:
– The drug is safe and effective.
– The labeling / package insert is appropriate and contains adequate information.
– GMP was used, and the drug’s identity, strength, quality and purity were preserved during manufacturing.

Question 9

Drug Approval Process (US) ANDA

Answer 9

• Abbreviated New Drug Application
• Application for a generic drug for an existing approved drug.
• Animal and clinical trial data is not required.
• Must demonstrate bioequivalence.

Question 10

Pharmacist’s Compounding Responsibilities

Answer 10

• Dispense medication in accordance with the prescriber’s order and with the requirements of the Board of Pharmacy.

1) Acceptable strength, quality and purity
2) Appropriate packaging and labeling