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 pharma.tech.edu@gmail.com

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