Bioanalytical Guidelines for Android APK

Description

Are you bioanalytical professional, researcher, student or sponsor of BA/BE study ? This app is for you to keep up to date on guidelines, news and knowledge related to bio-analysis. This app contains everything related to bio analysis and its related area (such as clinical research, clinical trial, BA/BE etc)

********* KEY FEATURES********

USFDA BIOANALYTICAL GUIDELINES

US FDA bioanalytical method validation guidelines, May 2018

Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers (September 2019)

Access to Product specific Guidance (OGD) for generic drug development

21 CFR part 11 guidelines

Access to USFDA official webinar (Free access)

EMA BIOANALYTICAL GUIDELINES

Guideline on bioanalytical method validation

ICH M10 on Bioanalytical Method Validation (Draft)

Product specific bioequivalence guidance

WHO GUIDELINES

Annex 9 Guidance for organizations performing in vivo bioequivalence studies

Direct access to WHO CRO inspection reports ?(WHOPIRs)

JAPAN (MHLW) BMV GUIDELINES

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)

ACCESS TO GLOBAL REGULATIONS

Australia (TGA)

Brazil (ANVISA)

Canada (Health Canada)

EDQM

India (CDSO)

ICH

Mexico (SALUD)

Switzerland (MEDSAFE)

Singapore

Thailand

OECD GLP

ACCESS TO MAJOR JOURNAL AND WHITE PAPERS ON BIOANALYSIS

WRIB white papers

Global CRO consortium (GCC) white papers

The AAPS Journal

Bioanalysis Journal

Article on various topic such as ISR, Stability, comparison of guideline etc

DISCUSSION FORUM

Open discussion forum to discuss on various topic of bioanalysis with the member of this app

Express your views and share the knowledge

LATEST NEWS AND UPDATE ON MAJOR REGULATIONS AND INDUSTRY

Get notification on latest news and updates directly from global regulatory agencies

CHEMICAL CALCULATOR

Quick calculation on

Solution preparation of various concentration

Percentage and Molarity calculations

Dilution of a stock solution to working concentration

Dilution to desired concentration

This app is a useful for Pharmaceutical, Bio-pharmaceutical & CRO professionals, scientists, Researchers, QA auditors, students, sponsors and as a general reference, just keeps your phone handy instead of carrying around a reference book.

We are still working on it, please write your suggestion in comment box or email us

to [email protected]

Please share the app in your network to get more people beneficial.