Acronyms

ADT accelerated degradation test

AFM atomic force microscopy
AH absolute humidity
AIC Akaike’s information criterion
ALT accelerated life test
API active pharmaceutical ingredient
ASAPprime® software developed by FreeThink Technologies for ASAP studies
ASEAN Association of South East Asian Nations
AT accelerated test
B humidity-sensitivity coefficient
BCS biological classification system
BIC Bayesian information criterion
CBE 30 change being effected in 30 Days
CBE change being effected
CFR The Code of Federal Regulations
cGMP the Current Good Manufacturing Practice regulations enforced by the US Food and
Drug Administration (FDA)
CHMP Committee for Medicinal Products for Human Use is the European Medicines
Agency’s (EMA) committee responsible for human medicines
CMA cortical material attribute
CPP critical process parameter
CQA critical qualities attribute
CRH critical relative humidity, also known as RH0
CSD colloidal silicon dioxide
CTA clinical trial application
CTD-Q Common Technical Dossier-Quality
CtQ critical-to-quality
DMSM dynamic moisture sorption microbalance
DOE design of experiment
DP drug product
DS drug substance (also known as API)
DSC differential scanning calorimetry
DVS dynamic gravimetric vapor sorption
EMA European Medicines Agency
ERH equilibrium relative humidity
EU European Union
FAST focused accelerated scientific testing
FDA United States Food and Drug Administration
FDC fixed-dose combination
FIH first in human

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xxviii Acronyms

FPP finished pharmaceutical products

FTE full-time equivalent
GAB Guggenheim, deBoer, and Anderson parameters
GCC Gulf Cooperation Council or Cooperation Council for the Arab States of the Gulf
GSK GlaxoSmithKline
H humidity (represents RH, AH, or vapor pressure for model B)
HDPE high-density polyethylene
HGP hard gelatin capsule
hPa pressure unit, 1 hPa ¼ 100 Pa (Newton/m2)
HPBCD hydroxypropyl beta cyclodextrin
HPLC high-performance liquid chromatography
HPMC hydroxy propyl methyl cellulose
ICH International Council for Harmonization of Technical Requirements for Pharmaceu-
ticals for Human Use
IMPD Investigational Medicinal Product Dossier (EU)
IND Investigational New Drug (IND) Application (United States)
IQ International Consortium for Innovation and Quality in Pharmaceutical Development
IR immediate release
JMP® Statistical Software from JMP a division of SAS
k rate of degradation
KF Karl Fisher water determination
kN kilonewton
kp kilopounds
LC label claim
LOD limit of detection
LOQ limit of quantitation
MA marketing authorization (EU)
MCC microcrystalline cellulose
MHRA Medicines and Healthcare Products Regulatory Agency
MKRH mean kinetic relative humidity
MKT mean kinetic temperature
MVTR moisture vapor transmission rate
NDA New Drug Application (United States)
NIR near-IR spectroscopy
NLT not less than
NMR nuclear magnetic resonance
NMT not more than
NPA nicotine polyacrilex
NRT nicotine replacement therapy
OM optical microscopy
OOS out of specification
PAS prior approval supplement
PCTFE polychlorotrifluoroethylene
PfOS powder for oral solution
 Acronyms xxix

PIB powder in bottle

PIC powder in capsule
PK pharmacokinetics
PRESS prediction error sum of squares
PVC polyvinyl chloride
PVDC polyvinylidene chloride
PXRD powder X-ray diffraction (also known as XRPD)
QbD quality by design
RAM Resodyn Acoustic Mixer
RBPS risk-based predictive stability, a synonym of accelerated predicative stability, used by
the IQ RBPS working group
RH relative humidity
RH0 critical relative humidity, also known as CRH
RMSE root-mean-squared error
rpm revolutions per minute
RRT relative retention time
RSD relative standard deviation
RT retention Time
SAS® once stood for “statistical analysis system,” an analytics software solution from SAS, a
North Carolina-based company
SDMT sorption–desorption moisture transfer
SEM standard error of the mean
SF-TS solid fraction tensile strength
SLLA shelf life-limiting attributes
SOF solid oral formulation
SRQA stability-related quality attribute
ssNMR solid-state NMR
SWAXS small- and wide-angle X-ray scattering
Tg glass transition temperature
TGA thermogravimetric analysis
Tm melting temperature
UN United Nations
USP United States Pharmacopeia
VP vapor pressure
WC water content
WHO World Health Organization
WVTR water vapor transmission rate (also known as MVTR)