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Human Pharmacology studies vis-à-vis Early Phase Clinical trials are essential to identify characteristics of an investigational drugin the early stages of development and to plan an appropriate development based on the drug's profile. Initial phase 1 clinical trials provide an early evaluation of short-term safety and tolerability and can provide pharmacodynamics and pharmacokinetics information needed to choose a suitable dosage range and administration schedule for initial therapeutic exploratory trial studies.
Phase 1 clinical trials start with the initial administration of an investigational new drug into humans. Studies in this phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteer subjects or certain types of patients, e.g. patients with mild hypertension. Drugs with significant potential toxicity, e.g. cytotoxic drugs, are usually studied in patients.
Phase 1 studies typically involve one or a combination of the following aspects
* Estimation of Initial Safety and Tolerability
* Pharmacokinetics
* Assessment of Pharmacodynamics
* Early measurement of drug activity
Phase 1 clinical trials start with the initial administration of an investigational new drug into humans. Studies in this phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteer subjects or certain types of patients, e.g. patients with mild hypertension. Drugs with significant potential toxicity, e.g. cytotoxic drugs, are usually studied in patients.
Phase 1 studies typically involve one or a combination of the following aspects
* Estimation of Initial Safety and Tolerability
* Pharmacokinetics
* Assessment of Pharmacodynamics
* Early measurement of drug activity
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