![](images/graphics/blank.gif)
Bioequivalence studies
-
HLX01 (HanliKang®) is a rituximab biosimilar that showed bioequivalence to reference rituximab in untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) in the phase 3 HLX01-NHL03 study. Here, we report the 5-year follow-up results from the open-label extension part. Patients were randomised to either rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 plus CHOP (H-CHOP) every 21 days for up to six cycles.
10p
vikoch
27-06-2024
1
1
Download
-
Tenofovir alafenamide (TAF), a prodrug of tenofovir (TFV), is currently used for treatment of chronic hepatitis B as first line recommendation. This study has been performed with the aim of development, validation, and application of LC-MS/MS procedure for quantitation of TAF and TFV in human plasma.
10p
vikissinger
21-12-2023
3
1
Download
-
Part 1 book "Comparative pharmacokinetics - Principles, techniques and applications" includes content: Nonlinear models, physiological models, physiological models, simultaneous pharmacokinetic–pharmacodynamic modeling, study design and data analysis, bioequivalence studies, population pharmacokinetic models, population pharmacokinetic models, interspecies extrapolations, interspecies extrapolations.
234p
oursky05
20-09-2023
6
1
Download
-
Part 2 book "Development and formulation of veterinary dosage forms" includes content: Formulation of vaccines, administration devices and techniques, specification development and stability assessment, bioavailability bioequivalence assessments, design of preclinical studies
206p
oursky04
14-09-2023
7
2
Download
-
Metformin is an oral antidiabetic drug from the biguanide class and it is the first-line drug chosen for the treatment of type 2 diabetes. This is a drug on the list of pharmaceutical substances required to report bioequivalence study data when registering the drug. Objectives: (1) To develope a capillary zone electrophoresis method for determining metformin hydrochloride in human plasma. (2) To validate the method.
10p
viangelamerkel
18-07-2022
7
2
Download
-
Quantitation was performed with multiple reaction monitoring in the negative ionization mode. The response of the method was linear over a dynamic range of 0.5–500, 1.0–750, and 0.25–150 ng/mL for LOS, EXP-3174, and HCTZ, respectively. Extent of signal suppression/enhancement was examined through postcolumn infusion. The effect of matrix components was evaluated by postextraction spiking and calculation of the slope of calibration lines. The method was successfully applied to a bioequivalence study of 50 mg losartan and 12.
20p
langthannam
29-12-2021
9
1
Download
-
The purpose of this study is to establish a high-performance liquid chromatography (HPLC) method to determine the MPA concentration in plasma in order to optimize the treatment efficacy of MPA or apply to bioequivalence studies.
6p
nguaconbaynhay11
07-04-2021
9
3
Download
-
Paracetamol/Orphenadrine is a fixed dose combination containing 35 mg orphenadrine and 450 mg paracetamol. It has analgesic and muscle relaxant properties and is widely available as generics.
13p
vivientiane2711
30-06-2020
16
1
Download
-
The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for industry describing how to meet criteria for requesting a waiver of in vivo bioavailability and bioequivalence studies for highly soluble, highly permeable (BCS Class I) drugs.
7p
caothientrangnguyen
09-05-2020
34
0
Download
-
The extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale.
20p
vimax2711
30-03-2020
29
1
Download
CHỦ ĐỀ BẠN MUỐN TÌM
![](images/graphics/blank.gif)