Research Journal of Pharmaceutical Dosage Forms and Technology

The success of a new drug development relies not only on early-stage drugs screening and preclinical animal studies but also PK/PD prediction prior to clinical study. In drug dosage design, the oral formulation is still the most commonly needed due to its convenience in administration. A number of recent reports in new drugs development have pointed out that PBPK modeling of ADME may lead to better prediction of bioavailability. In order to improve the development of NDA oral formulation, an alternative method using FDA approved PK data base and PAMPA Dissolution is proposed upon “similar PK parameters, similar PK profile” which is believed to potentially shorten the research time and reduce the clinical risk in NDA formulation development.