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ASTM E1073-01

(Test Method)

Standard Test Method for Obtaining a Pharmacological Profile with Mice

Standard Test Method for Obtaining a Pharmacological Profile with Mice

SCOPE
1.1 This test method is designed as a simple and inexpensive initial screening procedure for new compounds with unknown pharmacological properties, or for the comparative bioassay of new members of a chemical series with class reference standards. The test method, which is applicable to most pharmacologically active compounds including pesticides, will properly rank order both acute lethality and potency with a minimum expenditure of test material. It is intended as the first step in a multi-tiered development program.  
1.2 This standard does not purport to address the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
09-Oct-2001
ICS
11.120.01 - Pharmaceutics in general
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Current Stage
Ref Project

Relations

Replaces
ASTM E1073-91(1996) - Standard Test Method for Obtaining a Pharmacological Profile with Mice
Effective Date
10-Oct-2001
Replaced By
ASTM E1073-01(2005) - Standard Test Method for Obtaining a Pharmacological Profile with Mice (Withdrawn 2010)
Effective Date
01-Apr-2005

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ASTM E1073-01 - Standard Test Method for Obtaining a Pharmacological Profile with Mice
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E 1073 – 01
Standard Test Method for
1
Obtaining a Pharmacological Profile with Mice
This standard is issued under the fixed designation E 1073; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
1. Scope 3. Significance and Use
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1.1 This test method is designed as a simple and inexpen- 3.1 This test method is designed as an initial screening
sive initial screening procedure for new compounds with procedure for the selection of compounds worthy of more
unknown pharmacological properties, or for the comparative detailed study.
bioassay of new members of a chemical series with class 3.2 This test method is applicable to the study of most drugs
reference standards. The test method, which is applicable to and chemicals, and will properly estimate both lethal and
most pharmacologically active compounds including pesti- minimally effective dose levels.Although it is designed for the
cides, will properly rank order both acute lethality and potency study of single components, it can be used to study the
with a minimum expenditure of test material. It is intended as comparative toxicity of mixtures or formulations. The method
the first step in a multi-tiered development program. may not be applicable to oily substances which cause embo-
1.2 This standard does not purport to address all of the lism upon injection.
safety concerns, if any, associated with its use. It is the 3.3 This test method requires only small quantities of test
responsibility of the user of this standard to establish appro- materials (approximately 1 g), a fact that enhances its utility as
priate safety and health practices and determine the applica- the initial biological study for newly synthesized substances.
bility of regulatory limitations prior to use. 3.4 It is equally economical in its requirements for equip-
ment, space, personnel, and animals. Only a small laboratory,
2. Summary of Test Method
simple test equipment, and two technicians are needed to
2.1 Mice are injected intravenously with a dose of the test
conduct the experiments. Furthermore, an average of only
material and then observed for reaction signs, first those that thirty mice are required to conduct the entire test method.
can be detected by nonmanipulative tests, and then those
3.5 The procedure is applicable to a wide variety of mate-
sensed during a series of manipulative tests. rials. When results of this test were compared with those from
2.2 Two technicians are required to perform the experiment.
more detailed and specific animal tests, a high degree of
One injects the mice and records the data, while the other correlation was obtained. Further evidence of the utility of the
conducts the experiment at regularly scheduled time intervals
testwasdemonstratedbythefactthatahighcorrelationofrank
and dictates the findings. order potencies was found for a series of anticholinergics
2.3 The results obtained using this procedure indicate the
studied in both mice and men.
approximate median lethal dose (LD50), the approximate
4. Apparatus
median level of nonlethal reactions (MED50), the reaction
signs elicited at each dose level tested, and the degree of 4.1 All of the apparatus used for this test method is simple
severity of those signs. In contrast to the more commonly used and inexpensive. It can be made in any well-equipped labora-
median effective dose (ED50), the MED50 value may have tory workshop or, in some cases, obtained commercially.
been generated by one or more responses at the same dose, and 4.2 The major components of the apparatus are illustrated in
thus does not imply the 50 % level for a specific reaction sign. Figs. 1-5.
2.4 By judicious selection of acceptance criteria, the elimi- 4.3 Syringes and Needles:
nation rate for compounds tested using this procedure can be 4.3.1 One-quarter millilitre glass Tuberculin syringes, fitted
tailored to any desired level. with 0.75 in. (19 mm), 27-gage needles are recommended for
injection of all solutions except undiluted polyethylene glycol
(PEG) solutions. In the latter case, 24-gage needles must be
used to compensate for the viscosity of the solvent, and 50-µL
1
2,3
This test method is under the jurisdiction of ASTM Committee E-35 on
syringes are required to measure accurately the small vol-
PesticidesandisthedirectresponsibilityofSubcommitteeE35.26onSafetytoMan.
umes that are administered.
Current edition approved Oct. 10, 2001. Published November 2001. Originally
published as E 1073 – 85. Last previous edition E 1073 – 91 (1996)
2
Hamilton Microliter syringes with stainless steel needles available from
Hami
...

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4.1 Although some CM is used in the pharmaceutical industry (for example, purified water production), and some processes are inherently continuous individual unit operations (such as dry granulation and compression), these operations are generally operated in isolation and do not deliver the potential benefits of an integrated CM operation. The FDA Guidance for Industry PAT document specifically identifies that the introduction of continuous processing (now redefined as CM) may be one of the outcomes from the adoption of a science-based approach to process design.  
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1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
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1.2.5 Life-cycle management of MVDA model.  
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Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

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4.1 Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA’s initiative on pharmaceutical CGMPs for the 21st century.4  
4.2 This guide supports, and is consistent with, elements from ICH Q8 – Q11 and guidelines from USFDA, European Commission, Pharmaceutical Inspection Co-operation Scheme, and the China Food and Drug Administration.8  
4.3 According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the control strategy, will enable control of the CQAs, providing the confidence needed to show validation with each batch. This is as opposed to a traditional discrete process validation approach.
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1.1 This guide describes Continuous Process Verification as an alternate approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated, and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. Continuous Process Verification (ICH Q8) is similarly described as Continuous Quality Verification.  
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4.1 This test method establishes a selected set of conditions of temperature, relative humidity and rate of evaporation of the environment to which a mortar specimen of stated composition shall be subjected for a specified period of time during which its change in length is determined and designated “drying shrinkage.”  
4.2 The drying shrinkage of mortar as determined by this test method has a linear relation to the drying shrinkage of concrete made with the same cement and exposed to the same drying conditions.4 Hence this test method may be used when it is desired to develop data on the effect of a hydraulic cement on the drying shrinkage of concrete made with that cement.
SCOPE
1.1 This test method determines the change in length on drying of mortar bars containing hydraulic cement and graded standard sand.  
1.2 The values stated in SI units are to be regarded as standard. When combined standards are referenced, the selection of measurement system is at the user’s discretion subject to the requirements of the referenced standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Warning—Fresh hydraulic cementitious mixtures are caustic and may cause chemical burns to skin and tissue upon prolonged exposure).2  
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