Results 41 to 50 of about 781 (182)

Buspirone Hydrochloride Polymorphism: Stability, Solubility, Flow Properties, and Manufacturing Implications. [PDF]

Adv Pharmacol Pharm Sci
Buspirone hydrochloride, an anxiolytic agent, has two interconvertible polymorphic forms that may affect its physicochemical properties and therapeutic efficacy. Despite this relevance, polymorphism is often neglected in pharmaceutical analyses, potentially leading to inconsistent results and compromised drug performance.
Janning JA, Santiago VG, Ferreira ES, de Souza CO, da Silva MN, Reis FS, Colauto NB, Eising R.   +7 more
europepmc   +2 more sources

Biowaivers-An updated Review

Journal of Pharmaceutical Research, 2017
PURPOSE : A Biowaiver has been regarded as an official approval of the waiver for conducting a bioequivalence study in the context of an application for drug approval process. Bioequivalence is an important parameter in the process of drug development that is needed to be performed when there is a change in the formulation of dosage form.
N. Abilash, R. Chandramouli
openaire   +1 more source

In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing

Pharmaceutics, 2020
Purpose: To review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development.
Moawia M. Al-Tabakha, Muaed J. Alomar
doaj   +1 more source

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate

, 2022
S.1846-1862Literature data and results of experimental studies relevant to the decision to allow waiver of bioequivalence studies in humans for the approval of immediate release solid oral dosage forms containing cephalexin monohydrate are presented ...
Shah, V.P., Quizon, P.M., Groot, D.W., Abrahamsson, B., Tajiri, T., Mehta, M.U., Langguth, P., Plöger, G.F., Polli, J.E., Dressman, J., Cristofoletti, R., Parr, A.   +11 more
core   +1 more source

On the BCS biowaivers of orally disintegrating tablets

European Journal of Pharmaceutical Sciences, 2015
A recent paper in this journal by Ono and Sugano (2014) suggests BCS-based biowaivers can be applied to assess the bioequivalence of orally disintegrating tablets (ODTs) with immediate release formulations for Class III drugs. The assertion made by the paper is a concern for us for reasons including the following: the supposition has not been tested ...
Alfredo García-Arieta, John Gordon
openaire   +2 more sources

Biowaiver monographs for immediate release solid oral dosage forms: Aciclovir [PDF]

, 2008
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed.
Arnal, J., Bermejo, M., Barends, D. M., Midha, Kamal K., Shah, V. P., Dressman, Jennifer B., Junginger, H. E., Amidon, Gordon L., Stavchansky, S., Kopp, S., Gonzalez-Alvarez, I.   +10 more
core   +1 more source

DataSheet1_A Physiologically Based Pharmacokinetic Model for Studying the Biowaiver Risk of Biopharmaceutics Classification System Class I Drugs With Rapid Elimination: Dexketoprofen Trometamol Case Study.PDF

, 2022
Biowaiver based on the biopharmaceutics classification system (BCS) has been widely used in the global market for the approval of new generic drug products to avoid unnecessary in vivo bioequivalence (BE) studies.
Xian Zhang (191440), Jin Yang (86490), Qingqing Xiao (1755316), Lin Chen (54305), Xuxiao Ye (6629648), Kuan Hu (3349553), Wenping Li (440398), Wenqian Li (300451)   +7 more
core   +1 more source

Commercially Available Cell-Free Permeability Tests for Industrial Drug Development: Increased Sustainability through Reduction of In Vivo Studies

Pharmaceutics, 2023
Replacing in vivo with in vitro studies can increase sustainability in the development of medicines. This principle has already been applied in the biowaiver approach based on the biopharmaceutical classification system, BCS.
Ann-Christin Jacobsen, Sonja Visentin, Cosmin Butnarasu, Paul C. Stein, Massimiliano Pio di Cagno   +4 more
doaj   +1 more source

Challenges and Opportunities to Use Biowaivers to Compare Generics in China [PDF]

AAPS PharmSciTech, 2014
Biowaivers for class I drugs according to the biopharmaceutics classification system (BCS) were first introduced in 2000. The in vitro equivalence can be used to document bioequivalence between products. This study compared the in vitro dissolution behavior of two BCS class I drugs, amoxicillin and metronidazole, which are sold in China.
Jieyu, Zuo, Yuan, Gao, Nadia, Bou-Chacra, Raimar, Löbenberg   +3 more
openaire   +2 more sources

Utility of Biomarker-Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making. [PDF]

Clin Pharmacol Ther
The measurement of endogenous biomarkers in plasma and urine before and after administration of an investigational drug in a clinical study may provide an early indication of its drug–drug interaction (DDI) potential via a specific pathway. In the first international harmonized guideline on drug interaction studies, the International Council for ...
Ishiguro A, Kusuhara H, Kimoto E, Miyoshi S, Mizuno K, Hoshino M, Suzuki H.   +6 more
europepmc   +2 more sources