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Improvement of phase III psychotropic drug trials by intensive phase II work.

Phase III drug trials are expensive, time-consuming procedures that too often are a disappointment, since the evidence for drug efficacy proves marginal and unconvincing. We believe that this can be remedied by attention to numerous correctable flaws during Phase II. These multiple problems require a structural solution. The development of expert, psychopharmacologic facilities that focus on deficient areas of Phase II studies so as to develop an adequate Phase III design should prove helpful.

Clinical Trials as Topic↗

Blood and muscle metabolic responses to draught work of varying intensity and duration in horses.

Three standardbred trotters performed treadmill exercise at a velocity of 2 m s-1 with a draught load of both 34 kiloponds (kp) (test 1) and 80 kp (test 2), and also at 7 m s-1 with 34 kp (test 3). The heart rate increased to average values of 111 (+/- 5), 157 (+/- 10) and 197 (+/- 7) beats min-1 in tests 1, 2, and 3, respectively. Plasma free fatty acids increased only during tests 1 and 2. Blood lactate and muscle glucose-6-phosphate and lactate concentrations were low after tests 1 and 2, but high after test 3, where also muscle glycogen utilisation was greatest. Muscle creatine phosphate and adenosine triphosphate concentrations decreased after test 3 only. The study indicates that oxidative metabolism is most important for energy supply in muscles when exercise is performed with draught loads of both 34 and 80 kp at a low velocity. Glycogenolysis with lactate accumulation and phosphagen breakdown becomes much more important when, with a draught load of 34 kp, the velocity of exercise increases.

Adenosine Triphosphate↗