Bioanalytical Guidelines

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 GUIDELINESUS FDA bioanalytical method validation guidelines, May 2018Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers (September 2019)Access to Product specific Guidance (OGD) for generic drug development21 CFR part 11 guidelinesAccess to USFDA official webinar (Free access)EMA BIOANALYTICAL GUIDELINESGuideline on bioanalytical method validationICH M10 on Bioanalytical Method Validation (Draft)Product specific bioequivalence guidanceWHO GUIDELINESAnnex 9 Guidance for organizations performing in vivo bioequivalence studiesDirect access to WHO CRO inspection reports ?(WHOPIRs)JAPAN (MHLW) BMV GUIDELINESGuideline 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 REGULATIONSAustralia (TGA)Brazil (ANVISA)Canada (Health Canada)EDQMIndia (CDSO)ICHMexico (SALUD)Switzerland (MEDSAFE)SingaporeThailandOECD GLPACCESS TO MAJOR JOURNAL AND WHITE PAPERS ON BIOANALYSISWRIB white papersGlobal CRO consortium (GCC) white papersThe AAPS JournalBioanalysis JournalArticle on various topic such as ISR, Stability, comparison of guideline etcDISCUSSION FORUMOpen discussion forum to discuss on various topic of bioanalysis with the member of this appExpress your views and share the knowledgeLATEST NEWS AND UPDATE ON MAJOR REGULATIONS AND INDUSTRYGet notification on latest news and updates directly from global regulatory agenciesCHEMICAL CALCULATORQuick calculation onSolution preparation of various concentrationPercentage and Molarity calculationsDilution of a stock solution to working concentrationDilution to desired concentrationThis 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 usto pharma.tech.edu@gmail.comPlease share the app in your network to get more people beneficial.
License Free
Version 1.1
Operating System Android
System Requirements Requires Android 4.1 and up