International Council For Harmonisation (ich) - Pharma

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

A multianalyte LC-MS/MS method for accurate quantification of Nitrosamines in Olmesartan tablets.

Issue Release: 2024

Validation of a new protocol for a zebrafish MEFL (malformation or embryo-fetal lethality) test method that conforms to the ICH S5 (R3) guideline.

Issue Release: 2024

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

Issue Release: 2024

Innovative UPLC technique for concurrent quantification of etofenamate and benzyl nicotinate in the presence of methylparaben and benzyl alcohol in their topical cream: Greens, white, and Six Sigma methodologies.

Issue Release: 2024

Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation.

Issue Release: 2024

HPLC method for the determination of thymoquinone in growth cell medium.

Issue Release: 2024

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

Issue Release: 2024

LC-HRMS and NMR studies for the characterization of degradation impurities of ubrogepant along with the in silico approaches for the prediction of degradation and toxicity.

Issue Release: 2024

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

Issue Release: 2024

Developing generic templates to shape the future for conducting integrated research platform trials.

Issue Release: 2024

Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability.

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

A sustainable HPLC method coupled with diode array detection for versatile quantification of telmisartan, chlorthalidone and amlodipine in a fixed-dose antihypertensive formulation and dissolution studies.

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

Isoquinoline-based intrinsic fluorescence assessment of erythropoiesis-stimulating agent, Roxadustat (FG-4592), in tablets: applications to content uniformity and human plasma evaluation.

Issue Release: 2024

A Selective Gas Chromatography-Tandem Mass Spectrometry Method for Quantitation of Ethylene and Diethylene Glycol in Paediatric Syrups.

Issue Release: 2024

How Can Technology Aid in Patient Education?

How are New Drugs Discovered?

Why is Patient Education Important?

What Are Clinical Trials?

Why do Pharma Companies Use CROs?

What is Geriatric Care in Pharma?

Why is Medication Adherence Important?

Who Can Participate in Clinical Trials?

What Are the Challenges of Clinical Trials?

How Can ADEs be Prevented?

International Council For Harmonisation (ich) - Pharma

Relevant Publications

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