Clinical development plan dosage form

Prior to formulating a drug substance into a dosage form, the desired product type must be detemined for planning the product formulation activities. Then, various initial formulations are developed and then evaluated for selected parameters, such as drug-release profile, bioavailability, clinical effectiveness, and for any scale-up problems. The best formulation is selected and becomes the master formula. Each batch of the product subsequently prepared must meet the specifications established in this master formula. 

In pharmaceutical research and development (R D), a number of clinical trials are conducted to determine the therapeutic effectiveness of potential new drugs and novel dosage forms of well-established drugs. In order to provide the necessary clinical supplies in a timely manner and to plan for the manufacture of needed supplies, clinical supplies inventory systems are used. 

---