title: An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs.
abstract: Clinical pharmacology as an interdisciplinary science is unique in its capacity and the diversity of the methods and approaches it can provide to derive dosing recommendations in various subpopulations. This article illustrates cases where an integrated clinical pharmacology approach was used to derive dosing recommendations for psychiatry drugs within regulatory settings. The integrated approach is based on the view that once a drug is shown to be effective in the general population, it is reasonable to take into consideration other relevant findings and the use of alternative scientific tools and analysis to derive dosing recommendations in specific populations. The method provides useful means to solve the challenges of the paucity of available data and lead to clear dosing instructions. This in turn expands the benefits of any given drug to all individuals in which the drug is likely to be effective.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Islam R
authors.initials: IR
authors.lastname: Younis
authors.forename: Hobart
authors.initials: H
authors.lastname: Rogers
authors.forename: Huixia
authors.initials: H
authors.lastname: Zhang
authors.forename: Hao
authors.initials: H
authors.lastname: Zhu
authors.forename: Ramana S
authors.initials: RS
authors.lastname: Uppoor
authors.forename: Mehul U
authors.initials: MU
authors.lastname: Mehta
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage; D017277:Drug Approval; D006801:Humans; D054833:Isoindoles / Q000008:administration & dosage; D007555:Isoxazoles / Q000008:administration & dosage; D000069056:Lurasidone Hydrochloride; D008774:Methylphenidate / Q000008:administration & dosage; D000068882:Paliperidone Palmitate; D010601:Pharmacology, Clinical / Q000379:methods*; D010868:Pimozide / Q000008:administration & dosage; D011743:Pyrimidines / Q000008:administration & dosage; D013844:Thiazoles / Q000008:administration & dosage
chemical_list: D014150:Antipsychotic Agents; D000697:Central Nervous System Stimulants; D054833:Isoindoles; D007555:Isoxazoles; D011743:Pyrimidines; D013844:Thiazoles; D010868:Pimozide; D008774:Methylphenidate; D000069056:Lurasidone Hydrochloride; D000068882:Paliperidone Palmitate
keywords: clinical pharmacology (CPH); pharmacogenetics (PGN); pharmacokinectics & drug metabolism (PDM); psychiatry (PSY); regulatory/scientific affairs (REG)