Bupropion hydrochloride serves as a key treatment for major depressive disorder (MDD) and as a smoking cessation aid. It acts by inhibiting norepinephrine and dopamine reuptake, enhancing mood and reducing withdrawal symptoms. The drug is metabolized in the liver, primarily producing 6-hydroxybupropion, which contributes to its therapeutic action. Regulatory frameworks emphasize bioequivalence through in vivo pharmacokinetic studies. Advanced modeling approaches, such as PBPK, predict the drug's absorption, distribution, metabolism, and excretion (ADME). These models integrate in vitro dissolution data and formulation properties, optimizing product design and regulatory assessments while supporting personalized therapy.
Hsieh, N.-H., Bois, F.Y., Tsakalozou, E., Ni, Z., Yoon, M., Sun, W., Klein, M., Reisfeld, B., & Chiu, W.A. (2021) A Bayesian Population Physiologically Based Pharmacokinetic Absorption Modeling Approach to Support Generic Drug Development: Application to Bupropion Hydrochloride Oral Dosage Forms, J Pharmacokinet Pharmacodyn.
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Hsieh, N.-H., Bois, F.Y., Tsakalozou, E., Ni, Z., Yoon, M., Sun, W., Klein, M., Reisfeld, B., & Chiu, W.A. (2021) A Bayesian Population Physiologically Based Pharmacokinetic Absorption Modeling Approach to Support Generic Drug Development: Application to Bupropion Hydrochloride Oral Dosage Forms, J Pharmacokinet Pharmacodyn.
Hsieh, N.-H., Bois, F.Y., Tsakalozou, E., Ni, Z., Yoon, M., Sun, W., Klein, M., Reisfeld, B., & Chiu, W.A. (2021) A Bayesian Population Physiologically Based Pharmacokinetic Absorption Modeling Approach to Support Generic Drug Development: Application to Bupropion Hydrochloride Oral Dosage Forms, J Pharmacokinet Pharmacodyn.
Hsieh, N.-H., Bois, F.Y., Tsakalozou, E., Ni, Z., Yoon, M., Sun, W., Klein, M., Reisfeld, B., & Chiu, W.A. (2021) A Bayesian Population Physiologically Based Pharmacokinetic Absorption Modeling Approach to Support Generic Drug Development: Application to Bupropion Hydrochloride Oral Dosage Forms, J Pharmacokinet Pharmacodyn.