21 Cfr Part 11 - Bioanalytical Research

Relevant Publications

SATURN: assessing the feasibility of utilising existing registries for real-world evidence data collection to meet patients, regulatory, health technology assessment and payer requirements.

Issue Release: 2024

BASIS: BioAnalysis SEDFIT integrated software for cGMP analysis of SV-AUC data.

Issue Release: 2024

The Essential Guide to Computer System Validation in the Pharmaceutical Industry.

Issue Release: 2024

Data Integrity Issues In Pharmaceutical Industry: Common Observations, Challenges And Mitigations Strategies.

Issue Release: 2022

A quantitative assessment of epidemiological parameters required to investigate COVID-19 burden.

Issue Release: 2021

Development of a Prospective Real-World Data Clinical Registry of Children and Adolescents With Migraine.

Issue Release: 2019

Data Integrity: History, Issues, and Remediation of Issues.

Issue Release: 2017

Multivariate statistical process control in product quality review assessment - A case study.

Issue Release: 2017

Embedding data provenance into the Learning Health System to facilitate reproducible research.

Issue Release: 2016

A Multistate Investigation of Antibiotic-Resistant Salmonella enterica Serotype I 4,[5],12:i:- Infections as Part of an International Outbreak Associated with Frozen Feeder Rodents.

Issue Release: 2015

Current advances and strategies towards fully automated sample preparation for regulated LC-MS/MS bioanalysis.

Issue Release: 2014

Regulatory considerations for the classification of video monitoring in dissolution testing.

Issue Release: 2014

Scientific and Regulatory Policy Committee (SRPC) paper: validation of digital pathology systems in the regulated nonclinical environment.

Issue Release: 2012

A 21 CFR Part 11 compliant graphically based electronic system for clinical research documentation.

Issue Release: 2010

Establish a Transparent Chain-of-Custody to Mitigate Risk and Ensure Quality of Specialized Samples.

Issue Release: 2010

Use of imaging biomarkers for regulatory studies.

Issue Release: 2009

Application of wavelet denoising to improve compression efficiency while preserving integrity of digital micrographs.

Issue Release: 2008

Differences in the interpretation of the GLP requirements by OECD monitoring authorities: the point of view from the pharmaceutical industry.

Issue Release: 2008

The toxicology and carcinogenesis study of phenolphthalein (CAS No. 77-09-8) in genetically modified haploinsufficient p16(Ink4a)/p19(Arf) mice (feed study).

Issue Release: 2007

Society of Toxicologic Pathology position paper on pathology image data: compliance with 21 CFR Parts 58 and 11.

Issue Release: 2007

What is Quality Control (QC)?

Why is Annealing Important?

How Does Pressure Driven Flow Work in Microfluidics?

What are the advantages of Microchip CE?

What are the Best Practices for Successful Method Development?

How is Quality Ensured?

How Does PCR Work?

Why are Lipids Important?

What are the Regulatory Guidelines?

How is Cloud Computing Utilized in Bioanalytical Sciences?

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