...., page-288

Table test again
cos i forgot again

	Column 1	Column 2	Column 3	Column 4
0	Phase I		First Human Subjects.	Small group (20-100) volunteers. Safety assessment, tolerability. Usually inpatient clinic. Dose ranging/escalation. Usually healthy volunteers. Sometimes terminal patients used. Before/After food efficacy
1	Phase II		Larger group.	Larger groups (20-200). How well the dryg works, Safety assessments continued. This is usually the phase at which the drug will fail. Usually failure on toxicity or not working as planned (?).
2		IIA	Dosages	How much required
3			Efficacy	How will it works
4				Sometimes PI and PII can be combined. There can be randomised clinical trials or case series(tracking controlled patients)
5
6	Phase III		Randomized Controlled Multicentre Trials	larger Groups (200-3,000). Definitive assessment of efficacy compared to current treatment benchmark. Most Expensive, time consuoming and difficult to design and run. Regulatory approval might be concurrent.
7		IIIB		Allows some "label expansion" sponsor shows efficacy fo other types of patients/diseases beyond original.
8				It is expected that there are at least 2 successful PhaseIII trials demonstrating efficacy and safety - required by FDA, EMA(EuropeanUnion)
9				Some PII drugs can be marketed while in PIII with proper recommendations and guidelines. Immediate withdrawal will occur with adverse results.
10	Phase IV		Post Market Surveillance	Pharmocovigilance. Might be required by regulatory authories. Sponsor mya want further uses(markets) for it. Testing for interactions with other drugs. Certain population groups (preganant patient) Detection of long term adverse effects over a long term population.