Byrn Lecture 1 Flashcards
Many try to create a new drug into the field, however, very little actually succeed
There are over 10,000 drug candidates when beginning the process and you only admit 1
The FDA only approves 50 new drugs per year
This is a very long and expensive process to get a new drug into the market
Tunnel View of Drug Discovery and Production Pathway
Exploratory and Discovery: 30% success
Lead Identification: 65% success
Lead Optimization: 55% success
Preclinical Transition: 55% success
Phase 1: 70% success
Phase 2: 50% success
Phase 3: 65% success
Registration: 95% success
The lowest success rate is the initial drug exploratory and discovery
Drug Discovery and PreClinical
The drug discovery phase starts with 5,000 to 10,000 drugs
The Preclinical phase is brought down to about 250 drugs
Length: 3-6 years
Clinical Trials
Phase 1: 5 drugs are entered and tested on 20-100 volunteers
Phase 2: drugs are tested on 100-500 volunteers
Phase 3: drugs are tested on 1000 to 5000 volunteers
Length: 6-7 years
Pathway of Drug Candidates
- Potent
- Selective
- Reversible
- Targeted
- Soluble
- Long lasting
- Stable
- Permeable
- Non-toxic
- Non-Mutagenic
- Patentable
- Manufacturable
Cardinal Rules of Drug Development
- Know what you have (knowledgeable about every little detail)
- Make the same thing every time (repeatable)
Controlled by specifications: QUALITY IS KEY
- dissolve properly
- right amount of drug
- right M.P. of drug
United States Pharmacopeia and National Formulary
- Used pigeons to discover and examine potency (digitalis)
- set standards to allow for same drug in Washington to that in other locations of the world
- all generic drugs meet the same USP standards
USP and NF cont.
1820: USP established by physicians
1830: pharmacists become involved
2006: Spanish edition was introduced
Assay
test for the potency
Monographs of Drugs
Contain:
- Procedure for Assay
- Impurities and procedures to control them
- Chromatography systems
Drug Substance
aka the Active Pharmaceutical Ingredient- the chemical
Drug Product
the medicine
Intermediate Version of Drug Product
pharmaceutical compositions
Drug Substance Specification (specification of chemical)
Test
Description: found by looking at drug
Identification: obtained by IR are unique for chemicals
Assay: Pure/Impure percentages
Residual Palladium: toxic metal used to make chemicals
Loss of Drying
Drug Product Specifications (specification of mediation)
Test
Description
Identification by Chromatography
Dosage Amount
Verify Degradation Product
Dissolution: make sure drug dissolves
