Study Set Content:
New Drug Development & Approval Process
Discovery-Characterization-Preformulation Studies- Formulation Studies-Preclinical Studies-IND Application- Clinical Studies-New Drug Application-Postmarketing
Sources of New Drugs
• Natural sources • Synthesized in laboratories • Genetic engineering – Recombinant DNA – Monoclonal antibodies • Human gene therapy
under Genetic engineering
– Recombinant DNA – Monoclonal antibodies
A Goal Drug
• Produces desired effect(s) • Convenient administration • Minimal dosage • Minimal dosing frequency • Optimal onset • Optimal duration of activity • No side effects • Eliminated from body efficiently, completely, and without residual effect
Methods of Drug Discovery
Screening
Molecular modification of known agents
Mechanism-based drug design
Types of• Screening
– Random or Untargeted Screening – High-throughput screening
A prototype chemical compound with desired activity that may not possess all the desired feature
Lead Compound
Synthesis of derivatives which will ultimately lead to successive generations of the same pharmacologic type
A Lead Compound
A compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound
Prodrugs
characteristics of prodrugs
• Solubility • Absorption • Biostability • Prolonged release
an active ingredient that has never before been marketed in any form
New Molecular Entity (NME)
• Change of a previously approved formulation or method of manufacture
The FDA’s Definition of a New Drug
• Combination or a change in the usual proportion
The FDA’s Definition of a New Drug
• Proposed new use, new regimen, new route of administration, or new dosage form
The FDA’s Definition of a New Drug
The FDA’s Definition of a New Drug
SAFETY and EFFICACY
Drug Nomenclature
Empirical formula • Systematic Chemical name • Nonproprietary (Generic) Name
U.S. Adopted Names (USAN) Council
Nonproprietary (Generic) Name
The science concerned with drugs, their sources, appearance, chemistry, actions, and uses
Pharmacology
It can include properties, biochemical and physiologic effects, mechanisms of action, absorption, distribution, biotransformation, and excretion
Pharmacology
Pharmacology includes
Pharmacodynamics, Pharmacokinetics and Clinical Pharmacolog
