Bioanalytical guidelines is android application which is useful for pharmaceutical & CRO professionals, scientists, QA auditors, students, sponsors and as a general reference, just keeps your phone handy instead of carrying around a reference book.
This app contains the Major Bioanalytical guidelines and white papers. All guidelines and papers are taken from public domain
• US FDA Bioanalytical method validation guidelines 2018
• EMA guideline on Bioanalytical method validation
• Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in
Pharmaceutical Development (MHLW, Japan)
• Guideline on Bioanalytical Method Validation in Pharmaceutical Development (25 July
2013, MHLW, Japan)
• WHO: Annex 9 Guidance for organizations performing in vivo bioequivalence studies
• USFDA: Evaluation of Internal Standard Responses During Chromatographic
Bioanalysis: Questions and Answers
• USFDA Product Specific Guidance (OGD)
• USFDA 21 CFR Part 11 Guidelines
• EMA Product Specific BE Guidance
App also features
- Bioanalytical white papers from WRIB workshops, Global CRO consortium (GCC) and on various topics
- Solution Preparation calculators at your finger tips
- Regulatory news and updates to keep you up to date
We are still working on it, please write your suggestion in comment box or email us
to pharma.tech.edu@gmail.com
Please share the app in your network to get more people beneficial.
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