International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use (ich) - Public Health

Relevant Publications

The Need for Guidance in Antidepressant Drug Development: Revisiting the Role of the Forced Swim Test and Tail Suspension Test.

Issue Release: 2024

Method validation and characterization of stress degradation products of azelastine hydrochloride using LC-UV/PDA and LC-Q/TOF-MS studies.

Issue Release: 2024

Comparative physicochemical and structural characterisation studies establish high biosimilarity between BGL-ASP and reference insulin aspart.

Issue Release: 2024

Utility of Biomarker-Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making.

Issue Release: 2024

Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops.

Issue Release: 2024

Return of participant-level clinical trial results to participants: pilot of a simplified centralised approach.

Issue Release: 2024

Real-World Assessment of Personalized Approach With Voglibose Fixed-Dose Combination in Type 2 Diabetes Mellitus.

Issue Release: 2024

Application of estimand framework to the design and analysis of multi-regional clinical trials.

Issue Release: 2024

Comparing regulatory guidance on risk minimization/mitigation and the Reporting recommendation Intended for pharmaceutical Risk Minimization Evaluation Studies checklist.

Issue Release: 2024

An Exploratory Bibliometric Analysis of African Pharmacovigilance Research Output Using SCOPUS.

Issue Release: 2024

An Eco-Friendly RP-HPLC Method Development and Validation for Quantification of Favipiravir in Bulk and Tablet Dosage Form Followed by Forced Degradation Study.

Issue Release: 2024

Identification, characterisation and in silico ADMET prediction of ozenoxacin and its degradation products using high-performance liquid chromatography-photodiode array and liquid chromatography-quadrupole time-of-flight-tandem mass spectrometry.

Issue Release: 2024

A Validated Chiral Chromatography Method for Enantiomeric Separation of Pomalidomide in Human Plasma.

Issue Release: 2024

Application of the Estimand Framework to Anesthesia Trials.

Issue Release: 2024

[Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines].

Issue Release: 2024

Analytical method development, validation, and out-of-specification investigations for polyethylene glycol.

Issue Release: 2023

Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century.

Issue Release: 2023

Academia and industry agreement on a feasibility tool for first-time-in-human clinical trial units.

Issue Release: 2023

Global Harmonization of Immediate-Release Solid Oral Drug Product Bioequivalence Recommendations and the Impact on Generic Drug Development.

Issue Release: 2023

Comparison of the Speed of Enrollment for Clinical Trials Conducted by Japanese and Global Pharmaceutical Companies.

Issue Release: 2023

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