That's a good idea; my list so far:
sorry I lost spaces between texts as I cut & pasted
Ad Comm Advisory Committee of FDA
ADCS-ADL Alzheimer Disease Assessment Scale- Activities of Daily Living
ADAS-Cog Alzheimer Disease Assessment Scale- Cognition
AGM Annual General Meeting
BLA Biologics License Application
BTD
CNS Central Nervous System
CRO Contract Research Organization
CRL Complete response letter.
This is a response from a regulatory agency after submitting the NDA saying the drug is not approved but that it is approvable
if certain studies are performed or more data is reported or manufacturing issues cleared up.
CTN Clinical Trials Notification. This is the Australian equivalent to the FDA's IND or the EMA's Clinical Trials Application. Based on pre-clinical studies including PK/PD, toxicity, carcinogenicity, teratogenicity, etc and any human data if available, companies apply to be allowed to do clinical testing in their country or union.
DMT disease-modifying therapy
EHR Electronic Health Record
EMA European Medicines Agency
GCP Good Clinical Practice
HREC Human Research Ethics Committee
ICH International Conference of Harmonization. Regulatory agencies from practically all countries have now signed on to use standards and guidelines developed by the ICH and in accordance with GCP (also formalized Good Clinical Practice) to perform clinical studies. A clinical trial in the US is performed practically the same in the EU or AU allowing international large studies. Regulatory agencies use different abbreviations around the World and may have some built in requests but the clinical trial is performed nearly the same in all countries.
IND Investigational New Drug
IRB Institutional Review Board
LPLV Last participant's last visit
MAA Marketing Authorization Application
NDA New Drug application. The FDA and TGA use NDA and EMA uses
NDA Non-Disclosure Agreement
NICE National Institute for Health and Care Excellence(England)
NIH National Institute of Health
MAA Marketing Authorization Application (for EMA? ; comes after SA)
this is the application including detailed data from all studies that will be evaluated by the regulatory agency to decide if the drug can
be approved and marketed.
MMSE Mini-Mental State Examination
MOAs Mechanisms Of Action
MTD
OLE Open-Label Extension
OR. Odd Ratio
PDD Parkinson's Disease With Dementia
PK/PD
PTA Post Trial Access
RSBQ Rett Syndrome Behavior Questionnaire
RWE Real World Evidence
SA Scientific Advice (for EMA : European FDA)
SAP Statistical Analysis Plan
SPA Special Protocol Assessment
stat sig statistical significance
TGA Therapeutic Goods Administration (FDA equivalent of Australian government)
TLD Topline Data
TLR Topline Record
