Clinical Research Guidelines was an education app developed by Appz 4 U. It was removed from Google Play Jun 20, 2024 and is no longer available for download.
Download Statistics
Clinical Research Guidelines had been downloaded 4.4 thousand times before it became unavailable.
User Ratings
The app had no ratings.
App Information
Clinical Research Guidelines was free to download. The APK download size was 13.97 MB. The last available version was 1.1. The last update was on March 16, 2023.
Technical Requirements
Clinical Research Guidelines required Android 4.1+ or higher. The app had a content rating of Everyone. The app had been available on Google Play November 2019.
Description
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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Comments on Clinical Research Guidelines for Android
★★★★★
It's very good knowledge for all the employees of who are working in pharmaceutical companies
★★★★★
Very nice application. Very useful for Pharma and bioanalytical field.
★★★★★
Very nice Application whenever we have required update the knowledge Good job
★★★★★
As a Bioanalytical scientist, this app is very useful as guidance and white papers and also discussion forum. It's a great app. Thank you team. Just a small suggestion, please do fewer advertisements.
★★☆☆☆
Please guide me throughout it, the app is not opening. I am only able to see advertisement once cancelled I again see the advertisement and then the app stops
★★☆☆☆
Not open this app.... Only adds are coming
Technologies used by Clinical Research Guidelines
Clinical Research Guidelines is requesting 11 permissions and is using 12 libraries.
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Each subscription will automatically renew 3 days before the expiration date for
the same time period. Subscriptions can be cancelled at any time before the renewal.
