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Bringing a new drug to life Regulatory Sciences

For patients with severe neuropsychiatric conditions, the right drug was available—but there was a problem. The drug was in hard-tablet form, which often caused an issue with patient adherence. Patients would “cheek the pill,” instead of actually swallowing it. As a result, the patients remained at risk and physicians were frustrated. How would physicians get their patients to take their meds.

Spotlight

Fidia Farmaceutici SpA

Privately held, fully integrated Italian pharmaceutical company, with R&D, manufacturing, marketing, and sales capabilities. Fidia Farmaceutici S.p.A founded in Bologna (Italy) in 1946 and relocated to Abano Terme (Italy) in 1959, is part of the P & R Group since 1999, ranked among the top ten national chemical groups. The Group counts more than 1.800 employees, distributed between the chemical and pharmaceutical market segments.

OTHER WHITEPAPERS

QbD and PAT in Biopharmaceutical Development

whitePaper | July 12, 2022

As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA ’s process validation (PV) guidance (1) and International Conference on Harmonization.

A Vision for the Global Generic and Biosimilar Medicines Industry

whitePaper | May 22, 2021

One of the key roles of the generic and biosimilar medicines industry is specifically to promote the widest possible access to affordable medicines with high quality, safety, and efficacy for patients globally by introducing competition into the markets. Despite the many hurdles, the generic medicines companies have clearly lived up to the challenges posed by the pandemic as it is an industry that is quick to adapt and agile in manufacturing scale-up. During the outbreak of COVID-19, this industry was providing most of the medicines needed in Intensive Care Units to ventilate critically ill COVID patients. It is also providing most of the quality medicines dispensed around the world, especially for increasingly prevalent chronic diseases and is therefore a strong contributor to health outcomes globally.

Regenerative Medicine

whitePaper | September 16, 2022

T wice a year, we survey the cell and gene therapy landscape and ARM’s initiatives to advance the sector and provide an update to our members.

Drug Solubility and the Need for Speed

whitePaper | March 28, 2023

About 70% of new chemical entities (NCEs) are highly insoluble.1 It’s a fact that troubles small biotechnology companies and other drug manufacturers. Indeed, insoluble drugs present a wide range of challenges during development and, if not addressed, can ultimately render drugs ineffective in patients.

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Bringing a new drug to life Regulatory Sciences