The biopharmaceutics classification system (BCS) and the biopharmaceutics drug disposition classification system (BDDCS): beyond guidelines

A Charalabidis, M Sfouni, C Bergström… - International journal of …, 2019 - Elsevier
The recent impact of the Biopharmaceutics Classification System (BCS) and the
Biopharmaceutics Drug Disposition Classification System (BDDCS) on relevant scientific …

Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide

J Tamargo, JY Le Heuzey, P Mabo - European journal of clinical …, 2015 - Springer
Purpose The therapeutic index (TI) is the range of doses at which a medication is effective
without unacceptable adverse events. Drugs with a narrow TI (NTIDs) have a narrow …

In Vitro Dissolution of Fluconazole and Dipyridamole in Gastrointestinal Simulator (GIS), Predicting in Vivo Dissolution and Drug–Drug Interaction Caused by Acid …

K Matsui, Y Tsume, GE Amidon… - Molecular …, 2015 - ACS Publications
Weakly basic drugs typically exhibit pH-dependent solubility in the physiological pH range,
displaying supersaturation or precipitation along the gastrointestinal tract. Additionally, their …

Encapsulation of temozolomide in a calixarene nanocapsule improves its stability and enhances its therapeutic efficacy against glioblastoma

A Renziehausen, AD Tsiailanis, R Perryman… - Molecular cancer …, 2019 - AACR
The alkylating agent temozolomide (TMZ) is the first-line chemotherapeutic for glioblastoma
(GBM), a common and aggressive primary brain tumor in adults. However, its poor stability …

In Vitro Dissolution of Generic Immediate-Release Solid Oral Dosage Forms Containing BCS Class I Drugs: Comparative Assessment of Metronidazole, Zidovudine, and …

NHS Reddy, S Patnala, R Löbenberg, I Kanfer - AAPS PharmSciTech, 2014 - Springer
Biowaivers are recommended for immediate-release solid oral dosage forms using
dissolution testing as a surrogate for in vivo bioequivalence studies. Several guidance are …

Exploring the oxidation and iron binding profile of a cyclodextrin encapsulated quercetin complex unveiled a controlled complex dissociation through a chemical …

DA Diamantis, S Ramesova, CM Chatzigiannis… - … et Biophysica Acta (BBA …, 2018 - Elsevier
Background Flavonoids possess a rich polypharmacological profile and their biological role
is linked to their oxidation state protecting DNA from oxidative stress damage. However, their …

Generic switching and non-persistence among medicine users: a combined population-based questionnaire and register study

J Rathe, M Andersen, DE Jarbøl… - PLoS …, 2015 - journals.plos.org
Background Generic substitution means that one medicinal product is replaced by another
product containing the same active substance. It is strictly regulated with respect to its …

Generic products of antiepileptic drugs: a perspective on bioequivalence, bioavailability, and formulation switches using Monte Carlo simulations

V Karalis, P Macheras, M Bialer - CNS drugs, 2014 - Springer
Introduction Generic products of antiepileptic drugs (AEDs) are currently a controversial
topic as neurologists and patients are reluctant to switch from brand products to generics …

Comparative analysis of biopharmaceutic classification system (BCS) based biowaiver protocols to validate equivalence of a multisource product

F Khalid, SMF Hassan, M Mushtaque… - African Journal of …, 2020 - academicjournals.org
Biopharmaceutic classification system (BCS) is a substantial part of drug designing and
generic product development and has been accepted as a technique to renounce in-vivo …

[PDF][PDF] Performance of modified‐release tacrolimus after conversion in liver transplant patients indicates potentially favorable outcomes in selected cohorts

A Considine, JM Tredger, M Heneghan… - Liver …, 2015 - Wiley Online Library
Clinical outcomes, dose changes, and dose‐equalized tacrolimus concentrations were
examined sequentially in 129 liver transplantation (LT) recipients after successful …