Clinical Research Guidelines Application icon

Clinical Research Guidelines 1.1

14.9 MB / 10+ Downloads / Rating 5.0 - 1 reviews


See previous versions

Clinical Research Guidelines, developed and published by Appz 4 U, has released its latest version, 1.1, on 2024-11-29. This app falls under the Education category on the Google Play Store and has achieved over 1000 installs. It currently holds an overall rating of 5.0, based on 1 reviews.

Clinical Research Guidelines APK available on this page is compatible with all Android devices that meet the required specifications (Android 4.4+). It can also be installed on PC and Mac using an Android emulator such as Bluestacks, LDPlayer, and others.

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App Screenshot

App Screenshot

App Details

Package name: bioanalytical.guidelines2019

Updated: 2 months ago

Developer Name: Appz 4 U

Category: Education

App Permissions: Show more

Installation Instructions

This article outlines two straightforward methods for installing Clinical Research Guidelines on PC Windows and Mac.

Using BlueStacks

  1. Download the APK/XAPK file from this page.
  2. Install BlueStacks by visiting http://bluestacks.com.
  3. Open the APK/XAPK file by double-clicking it. This action will launch BlueStacks and begin the application's installation. If the APK file does not automatically open with BlueStacks, right-click on it and select 'Open with...', then navigate to BlueStacks. Alternatively, you can drag-and-drop the APK file onto the BlueStacks home screen.
  4. Wait a few seconds for the installation to complete. Once done, the installed app will appear on the BlueStacks home screen. Click its icon to start using the application.

Using LDPlayer

  1. Download and install LDPlayer from https://www.ldplayer.net.
  2. Drag the APK/XAPK file directly into LDPlayer.

If you have any questions, please don't hesitate to contact us.

Reviews

5 ★, on 2020-01-05
As a Bioanalytical scientist, this app is very useful as guidance and white papers and also discussion forum. It's great app. Thank you team.. Just a small suggestion, please do less advertisements.

5 ★, on 2020-04-09
This is an excellent application specially for those person who are working in Clinical, Bioanalytical, Quality Assurance Department in CRO companies. I appreciate to Appz4u team for this application.

5 ★, on 2019-12-15
Very nice application. Very useful for Pharma and bioanalytical field.

4 ★, on 2019-12-15
Very nice and get useful information in bioanalytical area

5 ★, on 2019-12-07
Suggest to include who, ich guidance also. Minimize pop up windows.

3 ★, on 2019-12-17
Super n easy to understand the guidelines

Previous Versions

Clinical Research Guidelines 1.1
2024-11-29 / 14.9 MB / Android 4.4+

Clinical Research Guidelines 1.1
2024-01-05 / 7.5 MB / Android 4.1+

About this app

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

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

App Permissions

Allows an app to access precise location.
Allows applications to open network sockets.
Allows applications to access information about networks.
Allows using PowerManager WakeLocks to keep processor from sleeping or screen from dimming.
Allows applications to access information about Wi-Fi networks.
Allows an application to receive the ACTION_BOOT_COMPLETED that is broadcast after the system finishes booting.