...treated and untreated animals. (ii) Placebo control: Comparison of the results of use of the new animal drug entity with an inactive preparation designed...administration of a placebo would be contrary to the well-being of the animals. (ir>) Historical control: In some circumstances involving diseases with...

...treated and untreated animals. (ii) Placebo control: Comparison of the results of use of the new animal drug entity with an inactive preparation designed...administration of a placebo would be contrary to the well-being of the animals. (i») Historical control: In some circumstances involving diseases with...

...drug entity with an inactive preparation designed to resemble the test drug as far as possible. (Hi) Active treatment control: An effective regimen of...circumstances, such as those Involving diseases with nigh and predictable mortality (acute leukemia of childhood), with signs and symptoms of predictable...

...drug entity with an inactive preparation designed to resemble the test drug as far as possible. (tit) Active treatment control: An effective regimen of...administration of a placebo would be contrary to the well-being of the animals. (iv) Historical control: In some circumstances involving diseases with high...

...drug entity with an inactive preparation designed to resemble the test drug as far as possible. (iti) Active treatment control: An effective regimen of...administration of a placebo would be contrary to the well-being of the animals. (¡ii) Historical control: In some circumstances involving diseases with...

...of therapy may be used for comparison, eg, where the condition treated is such that no treat in e nt or administration of a placebo .would be contrary to the interest of ; - tie patient. (iv) Historical control: In certain circumstances, such as those involving .diseases...

...drug entity with an inactive preparation designed to resemble the test drug as far as possible. (in) Active treatment control: An effective regimen of...would be contrary to the interest of the patient. <i«) Historical control: In certain circumstances, such as those involving diseases with high and...

...drug entity with an Inactive preparation designed to resemble the test drag aa far as possible. . (Hi) Active treatment control : An effective regimen of...or administration of a placebo would be contrary to tbe Interest of the patient. (iv) Historical control : In certain circumstances, .such as those involving...

...establish all of the " 21 CFR 314.111(a)(5)(ii)(a)(4)(iii) ("Active treatment control" allowed where "no treatment or administration of a placebo would be contrary to the interest of the patient."). - 36 conditions regarding FDA approval of ANDAs and paper NDAs, changes in the pioneer NDA after it...

...negligible, comparison of the objective results in comparable groups of treated and untreated patients. (it) Placebo control: Comparison of the results of use...would be contrary to the interest of the patient. (tu) Historical control: In certain circumstances, such as those involving diseases with high and predictable...