The answer to this question lies in knowing the moral standing of Phase IV studies and whether we ought to conduct them. And to know this, in part, we need to compare them to studies in Phases I, II, and III and then determine where Phase IV studies stand in relation to Phase I–III studies scientifically and commercially.

This article reviews an emerging therapeutic agent, which is currently in phase III development for the treatment of anemia secondary to chronic kidney disease, covering promising phase II results, drug characteristics, and the current phase III trials, which, if approved, may significantly impact the management of anemia in this patient population.

We describe a method to determine the phase III slope for the purpose of calculating indexes of ventilation heterogeneity, S(acin) and S(cond), from the multiple breath nitrogen washout test (MBNW). Our automated method applies a recursive, segmented linear regression technique to each breath of the MBNW test and determines the best point of transition, or breakpoint, between each phase of the ...

To date, outcomes for all Phase III clinical trials for traumatic brain injury (TBI) have been negative. The recent disappointing results of the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT) and Study of a Neuroprotective Agent, Progesterone, in Severe Traumatic Brain Injury (SyNAPSe) Phase III trials for progesterone in TBI have triggered considerable speculation about the...

Total number of abortions: 30,699.  60% of abortions were criminal and the re- mainder were due to:  (a)Cervical incompetence  (b) hypothyr oidism (c) Listeriosis (d) Toxoplasmosis (e) Luteal phase deficiency (f) Placental deficiency Mg) Rh and ABO incompatibility and unknown etiology.  Therapeutic abortions were also performed in several cases due to:  (a) Miliary tube...

A triphasic series of tail currents which follow depolarizing voltage-clamp pulses in Aplysia neurones L2-L6 was described in the preceding paper (Kramer & Zucker, 1985). In this paper, we examine the nature of the late outward component of the tail current (phase III) which generates the inter-burst hyperpolarization in unclamped cells. The phase III tail current does not reverse between -30 a...

The induction of phase II enzymes and phase III transporters contributes to the metabolism, detoxification of xenobiotics, antioxidant capacity, redox homeostasis and cell viability. Transactivation of the genes that encode for phase II enzymes and phase III transporters is coordinatively regulated by activating transcription factors in response to external stimuli. Comprehensive studies indica...

We report the development of Al0.7Ga0.3N /AlN quantum wells with high internal quantum efficiency. All samples had identical well and barrier thickness but the III/V flux ratio was varied during growth by increasing the Ga flux. The luminescence spectra show single peaks which vary from 220 nm III /V 1 to 250 nm III /V 1 with internal quantum efficiency varying from 5% to 50%, respectively. To ...

Randomized phase III trials provide the gold-standard evidence for the approval of new drugs: an experimental treatment is compared with the current standard of care to identify clinically relevant differences in a predefined endpoint. However, there are several problems relating to the current role of phase III trials in drug development including the limited clinical benefit observed for some...