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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