“You can’t fix by analysis what you bungled by design.”
—Light, Singer & Willett (𝘉𝘺 𝘋𝘦𝘴𝘪𝘨𝘯, 1990)
#MethodValidation studies in #pharma often employ outdated or scientifically unsound principles. Ensure yours is the best it can be. Get help from KsiGradSci.com.
#Pharmeuropa 33.1 features revision proposals for Uniformity of mass of singledose preparations (2.9.5), Disintegration test for solid rectal and vaginal dosage forms (2.9.2) and Vaginal preparations (1164). You are invited to comment before 31 March 2021 edqm.eu/en/news/updates-ph-e…
39-page list of 483 observations issued by @FDA_ORA to Novel Laboratories, Inc. d.b.a. LUPIN after Sep–Nov inspections, partly due to improperly validated & transferred methods. fda.gov/media/145108/downloa…
ALT Page 20 of 483 issued to Novels Laboratories, Inc.
Thinking about outsourcing your #MethodValidation? Performing the laboratory work in-house is still advisable if your site plans to be the primary user.
Ksɪɢʀʌd Scientific is your resource for all the rest: Protocol design; Data analysis; Report writing.
KsiGradSci.com
Anticipating some novel SEC (a.k.a. GPC), SEC–MALS, DLS, etc., articles from @Wiley_Chemistry's latest addition to their suite of journals, 𝘈𝘨𝘨𝘳𝘦𝘨𝘢𝘵𝘦.
onlinelibrary.wiley.com/toc/…
Please, always use a #colorblind friendly palette when drawing figures, especially when colours are important to distinguish points/regions. If I could I'd recolour all my previous figures. @AcademicChatter#academicchatter#AcademicTwitter