Results 51 to 60 of about 1,008 (71)

Biowaiver monograph for immediate-release solid oral dosage forms: Amlodipine besylate. [PDF]

J Pharm Sci
de la Cruz-Cruz P, García MA, Pérez-Urizar JT, Abrahamsson B, Cristofoletti R, Kambayashi A, Mehta M, Parr A, Polli JE, Shah VP, Charoo N, Talath S, Dressman J, Langguth P.   +13 more
europepmc   +1 more source

Effervescent-Assisted Dissolving Microneedle Array Patches for Localized Tetracycline Delivery: A Three-Layer Design for Rapid-Onset Antimicrobial Therapy in Superficial Skin Infections. [PDF]

ACS Omega
Chaiarwut S, Choipang C, Ngamplang P, Supaphol P.   +3 more
europepmc   +1 more source

Synergistic effects of sesame oil, extra virgin olive oil, psyllium extract, and dandelion extract on cholesterol gallstone dissolution: An in vitro comparative study against Rowachol®. [PDF]

PLoS One
Serri R, Dehneh N, Ghannam M, Sirri MR.
europepmc   +1 more source

Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting Report. [PDF]

Pharm Res
Tsakalozou E, Fang L, Skoda E, Nicholas T, Kollipara S, Ren K, Grosser S, Rege B, Roy P, Zhu H, Zhao L.   +10 more
europepmc   +1 more source

In Vitro Activity of Silver-Bound Titanium Dioxide (TiAB) Against Multidrug-Resistant Vaginal Pathogens. [PDF]

Diseases
Drago L, De La Motte LR, Stefàno E, Minasi V, Deflorio L, Benedetti S, Giarritiello F.   +6 more
europepmc   +1 more source

Controlled Crystallization Enables Facile Fine-Tuning of Physical-Chemical Properties of Nicergoline Toward Easier Processability. [PDF]

Pharmaceuticals (Basel)
Prudilová BB, Gabriel R, Otyepka M, Otyepková E.   +3 more
europepmc   +1 more source

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Physiologically Based Biopharmaceutics Model of Vildagliptin Modified Release (MR) Tablets to Predict In Vivo Performance and Establish Clinically Relevant Dissolution Specifications

AAPS PharmSciTech, 2022
The objective of the study was to predict pharmacokinetic (PK) and pharmacodynamic (PD) parameters of matrix-based modified release (MR) drug product of vildagliptin. Physiologically based biopharmaceutics modeling (PBBM) was developed using GastroPlus™ based on the available data including immediate-release (IR) drug product of vildagliptin.
Ramachandra Sangana
exaly   +3 more sources

Establishment of a clinically relevant specification for dissolution testing using physiologically based pharmacokinetic (PBPK) modeling approaches

European Journal of Pharmaceutics and Biopharmaceutics, 2020
This paper presented how to establish a clinically relevant specification (CRS) using in silico physiologically based pharmacokinetic (PBPK) modeling. Three different formulations of model drug products were used in the clinical studies in order to distinguish between bioequivalent (BE) batches from non-BE batches. A human PBPK model was constructed by
Tsuyoshi Mikkaichi, Takuya Miyano
exaly   +3 more sources

Establishing clinically relevant dissolution specifications for prodrug bioequivalence risk assessment: Integration of a dissolution/permeation system with physiologically based biopharmaceutics modeling in abiraterone acetate

European Journal of Pharmaceutics and Biopharmaceutics
Prodrugs with enzymatic activation requirements, such as the weakly basic biopharmaceutical classification system (BCS) class IV compound abiraterone acetate (ABA), face considerable bioequivalence (BE) risks owing to their pH-dependent solubility, food effects, and variable intestinal hydrolysis.
Tong Yuan, Jin Yang
exaly   +3 more sources