Drug Development and Approval

Chapter 2: New Drug Development and Approval Process
Average time course from drug synthesis to NDA approval							15 years
TRIVIAS
1st Human Gene therapy			Adenosine  Deaminase (ADA) deficiency *abnormal fxn of immune system
Reserpine			Rauwolfia; tranquilizer
Recombinant DNA			in lower species
Monoclonal Antibody			Higher animals
Drus with Low Thera index			Lidocaine Procainamide Quinidine
Goal Drug				Perfect drug
Lead Compound				Prototype chem compound has desired px activity, but may not possess all features like potency, low toxicity etc
Prodrugs				Metabolic transformation aster administration Ex: levodopaàcan cross BB, dopamine can’t Levo turns dopamine in brain
New drug				Change in formulation Method of manufacture Combination of old drugs New route, form,regimen
Acute or Short term toxicity studies				1 day
Subacute or Subchronic				Min 2 weeks
Chronic				90 to 180 days Ex: Carcinogenecity test; kills!! Mutagenecity- gene mutation (used Salmonella Typhimurium)
PHASES OF CLINICAL TESTING
1	20-100 px	Many months			Healthy volunteers #side effects #drugStructure #No EXCIPIENTS	SAFETY
2	Several Hundred	Months- 2years			Sick Patients	Safety EFFECTIVITY
3	Hundred to sev thousands	1-4 years			Sick patients #Usefulness in expanded patient base	Safety Effective DOSAGE
Orphan disease				Affects less 200,000 people, rare
Supplemental New Drug App				Changes of approve NDA
Abbreviated NDA				Generic drug App