Clinical Research Guidelines

Are you Clinical Research & 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********

CLINICAL RESEARCH GUIDELINES

USFDA GCP

ICH Guidance Documents

SOPS

Clinical Calculators

Clinical Research References

Clinical Trial Database

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 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, Clinical Research 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]

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