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First time in Man Safety / Tolerance |
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Bioavailability / Bioequivalence |
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Pharmacokinetics / Pharmacodynamics |
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Dose Response |
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Food effect studies |
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IV Infusion studies |
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Age/Gender |
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Drug interactions |
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Metabolic Balance |
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Special Populations – ( Healthy, Renal,
Hepatic, Diabetic, Post Menopausal, Testosterone deficiency, Elderly,
Obesity)
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