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If you are into clinical research already probably you know what it is all about!. Good Clinical Practices
ICH - International Conference of Harmonization
Structure
Three countries, USA, Japan and EU, with their 6 founding member parties (EU, EFPIA, MHLW, JPMA, FDA and PhRMA)
Observers (WHO, EFTA, Canada) - Non-voting members.
IFPMA representative
ICH operates via the ICH Steering Committee, i.e. 6 parties & IFPMA.
Parties: -
European Commission, European Union (EU)
European Federation of Pharmaceutical Industries Associations (EFPIA)
Ministry of Health, Labour and Welfare, Japan (MHLW)
Japan Pharmaceutical Manufacturers Association (JPMA)
US Food & Drug Administration (FDA)
Pharmaceutical Research & Manufacturers of America (PhRMA)
International Federations of Pharmaceutical Manufacturers Association (IFPMA)
Table of Contents - 8 sections
1. Glossary
2. The Principles of ICH-GCP
3. Institutional Review Board/Independent Ethics Committee (IRB/IEC)
4. Investigator
5. Sponsor
6. Clinical Trial Protocol & Protocol Amendment(s)
7. Investigator's Brochure
8. Essential Documents for Conduct of a Clinical Trial
Finalized Guidelines:
Efficacy (E1 to E12) GCP=E6 (1996)
Quality (Q1 to Q6)
Safety (S1 to S7 & M3)
Multidisciplinary (M1, M2, M4)
QUALITY TOPICS
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
Q1F : Stability Data Package for Registration Applications in Climatic Zones III and IV
Analytical Validation
Q2(R1) : Validation of Analytical Procedures: Text and Methodology
Previously: Text on Validation of Analytical Procedures
Validation of Analytical Procedures: Methodology (as Q2B)
Impurities
Q3A(R2) : Impurities in New Drug Substances
Q3B(R2) : Impurities in New Drug Products
Q3C(R3) : Impurities: Guideline for Residual Solvents
Pharmacopoeias
Q4 : Pharmacopoeias
Q4A : Pharmacopoeial Harmonisation
Q4B : Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)
Quality of Biotechnological Products
Q5A(R1) : Viral Safety Evaluation of Biotechnology 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 Characterisation 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 : Pharmaceutical Development
Quality Risk Management
Q9 : Quality Risk Management
Safety Topics
Carcinogenicity Studies
S1A : Need for Carcinogenicity Studies of Pharmaceuticals
S1B : Testing for Carcinogenicity of Pharmaceuticals
S1C(R1) : Dose Selection for Carcinogenicity Studies of Pharmaceuticals & Limit Dose
Genotoxicity Studies
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 : Single Dose Toxicity Tests
Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
Reproductive Toxicology
S5(R2) : New title: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility
Previously: Detection of Toxicity to Reproduction for Medicinal Products
Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products (in S5(R2))
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 the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
Immunotoxicology Studies
S8 : Immunotoxicity Studies for Human Pharmaceuticals
Joint Safety/Efficacy (Multidisciplinary) Topic
M3(R1) : Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.
lots to come.. Come back soon
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