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Whitepaper
Strategies for Accelerating the Development of Modified Release Oral Forms
MR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.
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Scientific Posters
Current practice in the conduct of the acceptability - Palatability - swallowability trials - A review of methodology associated with trials registered on the EU clinical trials portfolio
Guidance issued by the European Medicines Agency (EMA) states that patient acceptability must be an integral part of paediatric formulation development and described in the paediatric investigation plan (PIP). However, the methodology used to assess acceptability and the timing of this assessment is unclear. Previous reviews have used literature sources to review methods to assess acceptability with diverse methods reported
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Whitepaper
Accelerating the Developing of Orphan Drugs for Rare Diseases
Worldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.
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Whitepaper
Accelerating the Development of Oncology Medicines
Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.
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Fact Sheet
Project Management at Quotient Sciences
Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.
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Fact Sheet
How Do I Develop a Poorly Tasting Drug Substance into a Palatable Dosage Form?
Many drug substances are extremely bitter or have other aversive attributes, which can make developing palatable drug products extremely challenging. This is a common problem seen in medicines spanning all therapeutic areas, from antibiotics and painkillers to antihistamines and decongestants. The careful design and development of formulated oral drug products is key to ensuring patient acceptability and compliance for achieving the desired clinical outcomes.
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Fact Sheet
How Can I Accelerate Development of my 505(B)(2) Product?
Quotient has significant experience in 505(b)(2) product development and can support you in efficiently turning your innovative ideas into successful products. Over the past several years, the FDA’s 505(b)(2) regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules. There has been an increasing number of product approvals in the US using this approach and similarly, in the EU, the Hybrid Medicine Authorization process can provide new product opportunities for previously approved compounds.
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Webinar
The Role of Biopharmaceutics in Early Drug Development
This webinar discusses effective strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explores alternative approaches for accelerating your early development plan.
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Fact Sheet
Integrated Pharmacy Compounding and GMP Manufacturing Fact Sheet
Quotient Sciences provides integrated pharmacy compounding, formulation, GMP manufacturing and clinical testing solutions to help clients achieve their proof-of-concept (POC) milestone quickly, saving them precious development time and money. Begin your First-in-Human (FIH) Phase I testing with a fit-for-purpose, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, all within one organization.
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Scientific Posters
A Clinical Assessment of Delayed-Release Coated Capsule Compositions for Regional Gastrointestinal Delivery using Gamma Scintigraphy
Applied Molecular Transport Inc. are evaluating targeted drug delivery capsules for administration of locally acting drugs directly to the site of action in the gastrointestinal (GI) tract. This study used gamma scintigraphy to evaluate GI transit and release from 3 capsule prototypes with different coating systems (1). In addition, data on pH, temperature and pressure during GI transit was obtained using SmartPill® and correlated with scintigraphy data (2).
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Webinar
Accelerating formulation development to address poor drug solubility using Translational Pharmaceutics
This webinar examines how to accelerate formulation development in order to address poor drug solubility using Translational Pharmaceutics, showcasing examples of how Translational Pharmaceutics has been used across all phases of clinical development:
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Scientific Posters
Development of an X-ray Diffraction Method for the Quantification of API Recrystallized API
Typically, in the development of dry powder inhaler (DPI) formulations the use of a stable crystalline form of the active pharmaceutical ingredient (API) is desired. However, often in order to produce crystalline particles of suitable size for inhalation, micronization processes will be required, resulting in surface amorphous material which may affect the efficacy of the product. If required, additional conditioning/processing steps may then be applied to the API (or to ensure drug product stability under use) without requiring any additional solid state characterization of the API in the drug product.