Keywords: بیوایور; Transdermal; Quality and performance; Adhesives; In-vitro permeation; In-vitro release; Quality by design; Biowaiver; Residual drug analysis; Skin irritation and sensitization;
مقالات ISI بیوایور (ترجمه نشده)
مقالات زیر هنوز به فارسی ترجمه نشده اند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Keywords: بیوایور; Pharmacokinetic/pharmacodynamic models; ibuprofen; dissolution; Biopharmaceutics; bioequivalence; biowaiver; dose-response;
Keywords: بیوایور; fluconazole; bioequivalence; dissolution; biopharmaceutics classification system (BCS); permeability; solubility; biowaiver; therapeutic index; metabolism; elimination;
Keywords: بیوایور; Bioequivalence assessment; Generic; Topical dermatological products; Biowaiver;
Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission
Keywords: بیوایور; Strength; Biowaiver; EMA; US-FDA;
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate
Keywords: بیوایور; amoxicillin trihydrate; biowaiver; Biopharmaceutics Classification System (BCS); permeability; solubility; dissolution;
Commonality between BCS and TCS
Keywords: بیوایور; In vitro release; Biowaiver; Topical drug classification system; BCS; TCS
FaSSIF-V3, but not compendial media, appropriately detects differences in the peak and extent of exposure between reference and test formulations of ibuprofen
Keywords: بیوایور; Dissolution; Surface pH; Biopharmaceutics Classification System (BCS); Capacity of detection; Biowaiver
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin
Keywords: بیوایور; ribavirin; absorption; BCS; biowaiver; permeability; solubility;
Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations
Keywords: بیوایور; Excipients; Safety; Quality; IPEC; ICH; FDA; SUPAC; Pharmacopoeial considerations; Biowaiver;
A science based approach to topical drug classification system (TCS)
Keywords: بیوایور; Bioequivalence; Topical dosage forms; In vitro release; Biowaiver; Topical drug classification system; SUPAC-SS;
In-situ intestinal rat perfusions for human Fabs prediction and BCS permeability class determination: Investigation of the single-pass vs. the Doluisio experimental approaches
Keywords: بیوایور; Biopharmaceutics classification system; Intestinal permeability; Bioequivalence; Biowaiver; Oral drug absorption; Perfusion study;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam
Keywords: بیوایور; absorption; bioavailability; bioequivalence; biopharmaceutical classification system (BCS); biowaiver; levetiracetam; pharmacokinetics; permeability; solubility
Novel insights into excipient effects on the biopharmaceutics of APIs from different BCS classes: Lactose in solid oral dosage forms
Keywords: بیوایور; Biowaiver; Biopharmaceutic excipient classification; Pharmaceutical quality attributes; Quality by design; Lactose; Biopharmaceutic classification system
The complexity of intestinal permeability: Assigning the correct BCS classification through careful data interpretation
Keywords: بیوایور; BCS classification; Biowaiver; Intestinal absorption; Drug solubility; Segmental-dependent permeability
Application of the BCS biowaiver approach to assessing bioequivalence of orally disintegrating tablets with immediate release formulations
Keywords: بیوایور; Biowaiver; BCS; Orally disintegrating tablet; Dissolution
Pharmacokinetic simulations to explore dissolution criteria of BCS I and III biowaivers with and without MDR-1 efflux transporter
Keywords: بیوایور; BCS; Biowaiver; Bioequivalence; Drug dissolution; Pharmacokinetic simulation; Compartmental absorption and transit model
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Zidovudine (Azidothymidine)
Keywords: بیوایور; zidovudine; biopharmaceutics classification system; absorption; solubility; permeability; bioavailability; bioequivalence; biowaiver; dissolution;
A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: A cross-sectional survey with 500 bioequivalence studies
Keywords: بیوایور; biowaiver; BCS; BDDCS; bioequivalence; dissolution; permeability; solubility
COMMENTARY: Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Lamivudine
Keywords: بیوایور; absorption; bioavailability; bioequivalence; biopharmaceutics classification system (BCS); biowaiver; lamivudine; permeability; solubility;
Pharmacokinetic simulation of biowaiver criteria: The effects of gastric emptying, dissolution, absorption and elimination rates
Keywords: بیوایور; Biopharmaceutics classification system; Biowaiver; Gastrointestinal tract; Elimination rate; Formulation; Pharmacokinetic simulation; Bioavailability; Bioequivalency
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amitriptyline Hydrochloride*
Keywords: بیوایور; amitriptyline hydrochloride; Biopharmaceutics Classification System (BCS); permeability; solubility; absorption; biowaiver;
Level A in vitro-in vivo Correlation (IVIVC) Model with Bayesian Approach to Formulation Series
Keywords: بیوایور; Bayesian; bioequivalency; biowaiver; in vitro/in vivo correlations (IVIVC); levosimendan; internal and external predictability; mathematical model;