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Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S2(R1) – Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF)

Found: heritable effects is considered to be j ust as serious as the suspicion that a compound might induce cancer

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S10 – Photosafety Evaluation of Pharmaceuticals (PDF)

Found: Penetration of UVB l ight into human skin is mainly limited to the epidermis, while UVA can reach capillary blood

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S8 – Immunotoxicity Studies for Human Pharmaceuticals (PDF)

Found: Anti-proliferative agents used to treat cancer are an example of drugs that produce unintended immunosuppression

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E14 – The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF)

Found: thorough QT/QTc study’ in healthy volunteers due to safety or tolerability concer ns (e.g., cytotoxic cancer

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E3 – Structure and Content of Clinical Study Reports (PDF)

Found: Even if one variable receives primary attention (e.g., in a blood pressure study, supine blood pressure

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E2F – Development Safety Update Report (PDF)

Found: estive heart failure where all-cause mortality is the primary efficacy endpoint, disease progression in cancer

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S5(R3) – Revision of S5 Guidelines on Detection of Toxicity to Reproduction for Human Pharmaceuticals (PDF)

Found: • Should generate PD , toxicity , and TK data as not generally used for toxicology programs • Blood

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: Q3D(R2) – Guideline for Elemental Impurities (PDF)

Found: , cellular blood components or blood derivatives including plasma and plasma derivatives, dialysate

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S6(R1) – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF)

Found: This document does not cover antibiotics, allergenic extracts, heparin, vitamins, cellular blood components

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S7A – Safety Pharmacology Studies for Human Pharmaceuticals (PDF)

Found: Blood pressure, heart rate, and the electrocardio gram should be evaluated.