Development of metoprolol tartrate extended-release matrix tablet formulations for regulatory policy consideration

RV Nellore, GS Rekhi, AS Hussain, LG Tillman… - Journal of controlled …, 1998 - Elsevier
This research study was designed to develop model extended-release (ER) matrix tablet
formulations for metoprolol tartrate (100 mg) sufficiently sensitive to manufacturing variables …

Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablets

GS Rekhi, RV Nellore, AS Hussain, LG Tillman… - Journal of controlled …, 1999 - Elsevier
The objective of this study, was to examine the influence of critical formulation and processing
variables as described in the AAPS/FDA Workshop II report on scale-up of oral extended-…

Evaluation of biodegradable microspheres as vaccine adjuvant for hepatitis B surface antigen

RV Nellore, D Young, PG Pande… - PDA Journal of …, 1992 - journal.pda.org
Biodegradable microspheres were evaluated as vaccine adjuvants based on their ability to
provide prolonged release of incorporated agents. Hepatitis B surface antigen (HBSA) …

Optimization and validation of analytical conditions for bovine serum albumin using capillary electrophoresis

PG Pande, RV Nellore, HR Bhagat - Analytical biochemistry, 1992 - Elsevier
A quick and reproducible capillary electrophoresis method was optimized and validated for
the assay of bovine serum albumin (BSA). The effects of various parameters such as pH of …

High‐performance liquid chromatography method development and validation for simultaneous determination of five model compounds, antipyrine, metoprolol …

…, S Ghosh, V Sihorkar, R Nellore… - Biomedical …, 2006 - Wiley Online Library
A simple, precise, accurate and rugged reversed‐phase high‐performance liquid
chromatography (HPLC) method has been developed and validated for the simultaneous …

First-in-human phase 1 study of ETC-159 an oral PORCN inhbitor in patients with advanced solid tumours.

…, K Ethirajulu, P Yeo, D Chen, S Blanchard, R Nellore… - 2017 - ascopubs.org
2584 Background: The Wnt signalling pathway is involved in cellular proliferation,
differentiation, migration and implicated in stem cell function in several cancers. ETC-159 is a …

First‐in‐human, healthy volunteers integrated protocol of ETC‐206, an oral Mnk 1/2 kinase inhibitor oncology drug

…, SBH Gan, SE Blanchard, R Nellore… - Clinical and …, 2020 - Wiley Online Library
In the last decade, drug development has tackled substantial challenges to improve
efficiency and facilitate access to innovative medicines. Integrated clinical protocols and the …

[HTML][HTML] Regulatory considerations for biosimilars

R Nellore - Perspectives in Clinical Research, 2010 - journals.lww.com
Currently there is considerable interest in the legislative debate around generic biological
drugs or “biosimilars” in the EU and US due to the large, lucrative market that it offers to the …

Pre‐clinical and clinical evaluation of solution and soft gelatin capsule formulations for a BCS class 3 compound with atypical physicochemical properties

K Ramsay‐Olocco, L Alexandrova, R Nellore… - Journal of …, 2004 - Elsevier
R1481 is a sub‐type selective muscarinic receptor antagonist with the potential treatment of
overactive bladder. R1481 presents two challenges for drug development. The first is the …

[HTML][HTML] First-in-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Rapidly Developed SARS-CoV-2 Therapeutic Antibody …

…, LSU Lee, D Lye, X Xiaoying, R Nellore… - Infectious Diseases and …, 2022 - Springer
Introduction AOD01 is a novel, fully human immunoglobulin (Ig) G1 neutralizing monoclonal
antibody that was developed as a therapeutic against severe acute respiratory syndrome …