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ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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ICH (International Conference on Harmonization)
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medical product containing new drugs.
There are Six Parties from the research-based industry directly involved in the decision making process: EU, EFPIA, MHLW, JPMA, FDA and PhRMA.
In November 2005, the ICH Steering Committee adopted a new codification system for ICH Guidelines. The purpose of this new codification is to ensure that the numbering/coding of ICH Guidelines is more logical, consistent and clear. With the new codification revisions to an ICH Guideline are shown as (R1, (R2), (R3) depending on the number of revisions. Annexes or Addenda to Guidelines have now been incorporated into the core Guidelines and are indicated as revisions to the core Guideline (e.g., R1).
ICH Guidelines (Batch Q: Quality)
Stability
Q1A (R2) Stability Testing of New Drug Substances and Products
Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
Q1C Stability Testing for New Dosage Forms
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1E Evaluation of Stability Data
Analytical Validation
Q2 (R1) Validation of Analytical Procedures: Text and Methodology
Impurities
Q3A (R2) Impurities in New Drug Substances
Q3B (R2) Impurities in New Drug Products
Q3C (R4) Impurities: Guideline for Residual Solvents
Pharmacopeias
Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions
Q4B Annex 1 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Residue on Ignition/Sulphated Ash - General Chapter
Q4B Annex 2 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Test for extractable Volume of Parenteral Preparations - General Chapter
Q4B Annex 3 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Test for Particulate Contamination: Sub-Visible Particles – General Chapter
Q4B Annex 4A Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests – General Chapter
Q4B Annex 4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms – General Chapter
Q4B Annex 4C Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use – General Chapter
Q4B Annex 5 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Disintegration Test – General Chapter
Q4B Annex 6 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on University of Dosage Units – General Chapter
Q4B Annex 7 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Dissolution Test – General Chapter
Q4B Annex 8 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Sterility Chapter – General Chapter
Q4B Annex 9 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Tablet Friability – General Chapter
Q4B Annex 10 Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Polyacrylamide Gel Electrophoresis – General Chapter
Quality of Biotechnological Products
Q5A (R1) Viral Safety Evaluation of Biotechnological Products Derived from Cell Lines of Human or Animal Origin
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Q5D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
Specifications
Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Including Decision Trees)
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Good Manufacturing Practice
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Pharmaceutical Development
Q8 (R2) Pharmaceutical Development
Quality Risk Management
Q9 Quality Risk Management
Pharmaceutical Quality System
Q10 Pharmaceutical Quality System
ICH Guidelines (Batch S: Safety)
Safety
S1A Need for Carcinogenicity Studies of Pharmaceuticals
S1B Testing for Carcinogenicity of Pharmaceuticals
S1C (R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals
Genotoxicity Studies
S2 (R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
Toxicokinetics and Pharmacokinetics
S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
Toxicity Testing
S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
Reproductive Toxicity
S5 (R2) Detection of Toxicity to Reproduction for Medical Products & Toxicity to Male Fertility
Biotechnological Products
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Pharmacology Studies
S7A Safety Pharmacology Studies for Human Pharmaceuticals
S7B The Non-Clinical Evaluation of Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
Immunotoxicology Studies
S8 Immunotoxicity Studies for Human Pharmaceuticals
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
ICH Guidelines (Batch M: Multidisciplinary)
M2 ICSR (R2) Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1) companion document to E2B (R3)
M3 (R1) Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
M3 (R2) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
M4 (R3) Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Including the Annex; The Granularity Document
M4Q (R1) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
M4S (R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety
M4E (R1) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy
M5 Data Elements and Standards for Drug Dictionaries
ICH Guidelines (Batch E: Efficacy)
Efficacy
E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E2B (R3) Second Revision of the Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
To read together with M2 ICSR (R2) Message Specification (ICH ICSR DTD Version 2.1 February 2001)
E2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
E2E Pharmacovigilance Planning (PvP)
E2F Development Safety Update Report
Clinical Study Reports
E3 Structure and Content of Clinical Study Reports
Dose-Response Studies
E4 Dose-Response Information to Support Drug Registration
Ethnic Factors
E5 (R1) Ethnic Factors in the Acceptability of Foreign Clinical Data
Good Clinical Practice
E6 (R1) Good Clinical Practice: Consolidated Guideline
Clinical Trials
E7 Studies in Support of Special Populations: Geriatrics
E8 General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10 Choice of Control Group and Related Issues in Clinical Trials
E11 Clinical Investigation of Medicinal Products in the Pediatric Population
Guidelines for Clinical Evaluation by Therapeutic Category
E12 Principles for Clinical Evaluation of New Antihypertensive Drugs
Clinical Evaluation
E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhytmic Potential for Non-Antiarrhytmic Drugs
Pharmacogenomics
E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
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