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Latest ICH Guidance updates: M15-Model-Informed Drug Development, E6(R3)-Good Clinical Practice: Annex 2, & E11A -Pediatric Extrapolation
The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...
Sharan Murugan
Dec 28, 20242 min read
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ICH Seeks Market Consultation for Global Post-Approval CMC Assessment Cloud Solution
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)Â has issued a Request for...
Sharan Murugan
Nov 30, 20242 min read
35 views
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FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers
Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...
Sharan Murugan
Aug 3, 20242 min read
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ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning,...
Sharan Murugan
Jul 3, 20242 min read
22 views
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ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
Sharan Murugan
May 31, 20242 min read
33 views
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ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
Last week the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Office of Regulatory Policy, and the...
Sharan Murugan
Mar 13, 20241 min read
45 views
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USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
Sharan Murugan
Jul 24, 20232 min read
30 views
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USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...
Sharan Murugan
Jun 6, 20231 min read
14 views
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ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
May 4, 20231 min read
65 views
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ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...
Sharan Murugan
Apr 29, 20232 min read
20 views
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ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...
Sharan Murugan
Mar 1, 20231 min read
29 views
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ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...
Sharan Murugan
Feb 1, 20231 min read
55 views
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ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...
Sharan Murugan
Dec 27, 20222 min read
103 views
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ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...
Sharan Murugan
Sep 17, 20221 min read
27 views
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ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...
Sharan Murugan
Aug 27, 20222 min read
35 views
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ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...
Sharan Murugan
Jun 18, 20222 min read
21 views
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ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study
As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...
Sharan Murugan
Apr 10, 20222 min read
13 views
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ICH's updated Draft Guidelines on Analytical Method Development
Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support...
Sharan Murugan
Apr 4, 20221 min read
38 views
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ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...
Sharan Murugan
Oct 13, 20211 min read
47 views
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ICH Q13 Draft Guideline reaches Step 2 of the ICH process
ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...
Sharan Murugan
Jul 28, 20211 min read
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