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

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

What is the Role of Post-Market Surveillance?

Are There Any Contraindications?

How Do Vaccines Activate T Cells?

How is Informed Consent Obtained?

How Can Technology Improve Vaccine Access?

How Do Plasmodium Parasites Cause Malaria?

What Are the Major Challenges in Vaccinating Displaced Populations?

What are the social implications of vaccine hesitancy?

What is the Role of Public Education in Vaccine Management?

How Can Measles Outbreaks Be Prevented?

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