Unattributed Code Systems

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External References

Type Reference Content
web unitsofmeasure.org Include these codes as defined in http://unitsofmeasure.org
Code Display
%{WeightToWeight} percent WeightToWeight
%{WeightToVolume} percent WeightToVolume
% percent
%{VolumeToVolume} percent VolumeToVolume
web unitsofmeasure.org Include these codes as defined in http://unitsofmeasure.org
Code Display
{actuation} actuation
[Amb'a'1'U] Amb a 1 units
[arb'U] arbitrary unit
[Btu] British thermal unit
{Can} Can
cm centimeter
cP centiPoise
[CFU] colony forming unit
m3 cubic meter
d day
Cel degree Celsius
[degF] degree Fahrenheit
deg degree
[EU] Ehrlich unit
U enzyme Unit
[gal_us] Queen Anne's wine gallon
g gram
h hour
[in_i] inch (international)
[iU] international unit
K Kelvin
{kDa} kiloDalton
kg kilogram
kgf kilogram-force
[lbf_av] pound force
L liter
m meter
ug microgram
ug/{actuation} micrograms per actuation
uL microliter
umol micromole
um micrometer
umho micromho
mg milligram
mL milliliter
mm millimeter
mmol millimole
mosm milliosmole
mS milliSiemens
min minute
mol mole
mo month
ng nanogram
nm nanometer
nmol nanomole
N Newton
1 1*
[oz_av] ounce (US and British)
[ppb] part per billion
[ppm] part per million
[pptr] part per trillion
[ppth] parts per thousand
{tot} particles total count
pg picogram
pmol picomole
[pt_us] pint
[lb_av] pound (US and British)
[psi] pound per square inch
[qt_us] quart
rad radian
s second
m2 square meter
{tbl} tablets
u unified atomic mass unit
(m2.d) meter squared in 24 hours
{Vial} Vial
wk week
a year
[pH] [pH]
[dqt_us] dry quart
[dpt_us] dry pint
mho mho
ms millisecond
S Siemens
[NTU] Nephelometric Turbidity Unit
[FNU] Formazin Nephelometric Unit
{JTU} Jackson Turbidity Unit
mg% milligram per deciliter
%{WeightToWeight} percent WeightToWeight
%{WeightToVolume} percent WeightToVolume
% percent
%{VolumeToVolume} percent VolumeToVolume
web github.com Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
web en.wikipedia.org Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. HATEOAS ).
web www.omg.org Mappings for ServD ( http://www.omg.org/spec/ServD/1.0/ )
web www.ich.org Drug product application content, including PQ/CMC, is harmonized internationally by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ). The content standard for drug product applications is the ICH Common Technical Document (CTD) guideline which also has an ICH Topic ID of M4 (Multidisciplinary Guideline 4). The PQ/CMC content within the M4 Topic is identified as the Quality content and the section of the M4 guideline specific to PQ-CMC content is M4Q. When revision numbers are included, the resulting identifier is M4Q(R1), M4Q(R2), etc. The M4 guideline associates a “module” framework with numbers so that Module 2.3 is the Quality Overall Summary (one of several summaries in Module 2) and Module 3 is the Quality Data section (see the ICH CTD page ). The M4Q CTD guideline describes the content of both CTD Modules 2.3 and 3. Note that ICH terms typically use a British English spelling.
web ich.org Drug product application content, including PQ/CMC, is harmonized internationally by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ). The content standard for drug product applications is the ICH Common Technical Document (CTD) guideline which also has an ICH Topic ID of M4 (Multidisciplinary Guideline 4). The PQ/CMC content within the M4 Topic is identified as the Quality content and the section of the M4 guideline specific to PQ-CMC content is M4Q. When revision numbers are included, the resulting identifier is M4Q(R1), M4Q(R2), etc. The M4 guideline associates a “module” framework with numbers so that Module 2.3 is the Quality Overall Summary (one of several summaries in Module 2) and Module 3 is the Quality Data section (see the ICH CTD page ). The M4Q CTD guideline describes the content of both CTD Modules 2.3 and 3. Note that ICH terms typically use a British English spelling.
web www.ich.org ICH created an associated guideline to harmonize the electronic exchange of CTD content (e.g., sections or subsections in pdf, xml, etc.) which is called the electronic Common Technical Document ( eCTD ) and is identified as the ICH M8 Topic (Multidisciplinary Guideline 8). Within the ICH eCTD (M8) guideline, the format and technology for exchange is defined. The eCTD guideline provides the regulatory application exchange framework in which FHIR-based CTD content “document bundles” will be exchanged between industry and the FDA. NOTE : Details about how to configure an eCTD submission to use FHIR-based PQ/CMC document bundles are outside of the scope of this IG. The eCTD is designed to reflect CTD concepts and the two acronyms are often used interchangeably.
web www.iso.org ISO maintains the copyright on the country codes, and controls its use carefully. For further details see the ISO 3166 web page: https://www.iso.org/iso-3166-country-codes.html
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web ucum.org The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
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