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Blog2018-03-04T18:00:46+00:00
507, 2018

5 Key Challenges in Medical Device Preclinical Testing

By |July 5th, 2018|Categories: Preclinical|Tags: , |0 Comments

The engineering of a medical device constitutes only one aspect of its viability. In order to obtain regulatory approval, a device also needs to comply with biocompatibility and sterilization standards. Raw materials, packaging, and design may all impact a device’s safety and compatibility, and a preclinical assessment of all these [...]

1506, 2018

Preformulation

By |June 15th, 2018|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

A clear understanding of a drug’s chemical properties will lead to a better formulation design. Before a formulation is developed around an active pharmaceutical ingredient (API), that API itself must be clearly understood. A careful analysis of the solubility, stability and other chemical properties of a newly discovered API will [...]

606, 2018

Clinical Trial Material Manufacturing

By |June 6th, 2018|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

Logistical challenges demand close collaboration from the early stages of the development process. Some fundamental requirements apply to all clinical trial supply chains. Manufacturing facilities must comply with Good Manufacturing Practice (GMP) guidelines, including effective sterilization and cold chain management. Formulations must be screened regularly for quality, and containers must [...]

1905, 2018

Polymorph Screening

By |May 19th, 2018|Categories: Generic & Commercial Drug Manufacturing Services|0 Comments

Advancing technologies are helping developers discover polymorphs more rapidly than ever. But production and legal issues can pose significant challenges. An active pharmaceutical ingredient (API) can take many forms. This is particularly true of solid-state compounds, whose salts can form according to an unpredictable range of structures. These crystalline structural [...]

1405, 2018

Liquid Oral Suspensions

By |May 14th, 2018|Categories: Generic & Commercial Drug Manufacturing Services|0 Comments

These dosage forms provide key advantages over other liquids, but federal guidelines advise caution in manufacturing. The broad category of liquid oral doses includes a diverse group of dosage forms, from monophasic forms like syrups, spirits, elixirs and extracts, to biphasic forms like suspensions, emulsions and mixtures. While each of [...]

1105, 2018

Dosage Forms

By |May 11th, 2018|Categories: Uncategorized|0 Comments

Manufacturing of all dosage forms is becoming increasingly specialized, demanding expertise from developers and CMOs alike. As an active pharmaceutical ingredient (API) is developed into a formulation, the manufacturer must naturally consider how the drug will be administered. The question of dosage forms has more answers today than ever before; [...]

405, 2018

Commercial Drug Manufacturing

By |May 4th, 2018|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

Scaling up to the commercial stage demands strategic thinking – but it can also bring significant new opportunities. Once a viable active pharmaceutical ingredient (API) has been developed, and clinical trials have delivered promising results, the next step is to scale up the manufacturing pipeline to produce commercial-scale batches of [...]

1804, 2018

Ophthalmic Formulation Development

By |April 18th, 2018|Categories: Formulation Development & Clinical Trial Materials, Ophthalmic|Tags: , , , , , |0 Comments

Formulations intended for ocular delivery must comply with a wide range of guidelines, both physiological and regulatory. Ophthalmics remain one of the most successful categories of pharmaceuticals worldwide, with a market cap of at least $17 billion, and a compound annual growth rate (CAGR) of six percent. In contrast with [...]

504, 2018

3 Challenging Complexities of Preclinical Toxicology Studies

By |April 5th, 2018|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , |0 Comments

Each phase of tox screening introduces unique variables into the process, demanding agility and expertise from testing teams. by Susan Thompson, Technical Director at VxP Pharma Once a drug formulation has demonstrated its viability as a potential candidate for clinical applications, it must be vetted for potential toxicity to animal [...]