Equipoise rule definition

A Phase IV trial is also known as postmarketing surveillance trial, or informally as a confirmatory trial . Phase IV trials involve the safety surveillance ( pharmacovigilance ) and ongoing technical support of a drug after it receives permission to be sold (. after approval under the FDA Accelerated Approval Program ). [17] Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). [2] [6] The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. [6] [17] Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses; recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx). The minimum time period mandatory for Phase IV clinical trials is 2 years. [ citation needed ]

But it is more (to the point) that it is not lawful to draw conclusions about anything else than the subject which was immediately in hand. In short, if it were lawful to transfer the parables to other ends (than they were originally intended for), it would be rather to martyrdom that we would direct the hope drawn from those now in question; for that is the only thing which, after all his substance has been squandered, will be able to restore the son; and will joyfully proclaim that the drachma has been found, albeit among all (rubbish) on a dungheap; and will carry back into the flock on the shoulders of the Lord Himself the ewe, fugitive though she have been over all that is rough and rugged. But we prefer, if it must be so, to be less wise in the Scriptures , than to be wise against them. We are as much bound to keep the sense of the Lord as His precept . Transgression in interpretation is not lighter than in conversation.

Definition of balance

  • compute credits and debits of an account
  • bring into balance or equilibrium; "She has to balance work and her domestic duties"; "balance the two weights"
  • be in equilibrium; "He was balancing on one foot"
  • a scale for weighing; depends on pull of gravity
  • equality between the totals of the credit and debit sides of an account
  • the difference between the totals of the credit and debit sides of an account
  • equality of distribution
  • a state of equilibrium

Equipoise rule definition

equipoise rule definition

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equipoise rule definition

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