Inhalation AUGUST 2020 19
4. Health Canada: Draft Guidance for Industry.
Pharmaceutical Quality of Inhalation and Nasal
Products. 06-106624-547. 2006. https://www.
canada.ca/en/health-canada/services/drugs-health-
products/drug- products/applications- submissions/
guidance- documents/chemical- entity- products-
quality/guidance- industry- pharmaceutical- quality-
inhalation- nasal-products.html.
5. Tougas TP, Christopher D, Mitchell JP, Strickland
H, Wyka B, Van Oort M, et al. Improved quality con-
trol metrics for cascade impaction measurements of
orally inhaled drug products (OIPs). AAPS PharmSci-
Tech. 2009;10(4):1276-1285.
6. Tougas TP, Goodey AP, Hardwell G, Mitchell J, Lya-
pustina S. A comparison of the performance of E -
cient Data Analysis versus Fine Particle Dose as metrics
for the quality control of aerodynamic particle size
distributions of orally inhaled pharmaceuticals. AAPS
PharmSciTech. 2017;18(2):451-461.
7. Peri, P. Assessing quality of inhaled products and links
to e cacy and safety: Bringing value to the patient in a
changing world. IPAC-RS Conference, March 30, 2011.
Adrian P. Goodey , PhD, (corresponding author) is Princi-
pal Scientist, Analytical Sciences, Merck & Co., Inc., Rah-
way, New Jersey, US, adrian.goodey@merck.com. Jolyon
P. Mitchell, PhD, FRSC(UK), CChem, CSci is Scienti c
Consultant, Jolyon Mitchell Inhaler Consulting Services,
Inc., London, Canada, mitchelljolyon@gmail.com. Wil-
liam H. Doub, PhD, is Consultant, OINDP In Vitro
Analysis, St. Louis, Missouri, US, oindp_iva1@charter.
net. J. David Christopher, MSc, is Executive Director,
Research CMC Statistics, Merck & Co., Inc., West Point,
Pennsylvania, US, j.david.christopher@merck.com.
To read the rst article in this series, " e liability of
fine particle dose (FPD)," see Inhalation's website
home page or article archive.
References
1. Goodey AP, Mitchell JP, Doub WH, Christopher
JD. e liability of ne particle dose (FPD). Inhala-
tion. 2020; 14(4):18-22.
2. United States Food and Drug Administration
Draft Guidance: Metered Dose Inhaler (MDI)
and Dry Powder Inhaler (DPI) Products—Quality
Considerations. Docket FDA-2018-D-1098. April
2018. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/metered-dose-
inhaler- mdi-and-dry-powder-inhaler-dpi-drug-
products- quality-considerations.
3. European Medicines Agency: Guideline on the
Pharmaceutical Quality of Inhalation and Nasal
Products. EMEA/CHMP/QWP/49313/2005 Corr.
2006. https://www.ema.europa.eu/en/pharmaceutical-
quality- inhalation- nasal- products.
The IPAC-RS APSD Database
e APSD data used in this manuscript originate
from QC testing of actual OIPs. The blinded
IPAC-RS database includes APSD data for 34
OIPs, which are either commercially marketed
or in late development (Phase IIB or later), from
seven manufacturers. To ensure blinding and
confidentiality, APSD data were submitted to
the IPAC-RS secretariat. For each product, the
APSD data consist of API recoveries from individ-
ual impactor components (e.g., induction port,
stages, filter, etc.) expressed as a percent of the
product label claim. More information regarding
the database can be found at:
https://wayback.archive-it.org/7993/20170405
182408/https:/www.fda.gov/ohrms/dockets/
ac/00/techrepro/3609_rpt2.pdf
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SPUTUM
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