Featured Articles
EXECUTIVE INTERVIEW - PCI Pharma Services: The Global, Integrated CDMO Partner of Choice
John Ross, Senior Vice President of Development and Manufacturing at PCI Pharma Services, discusses what it means to be the partner of choice in a very dynamic industry.
MICROCRYSTALLINE CELLULOSE - N-nitrosamine Risk Assessments for Oral Dosage Forms
Takako Koyamatsu, Shohei Mikami, PharmD, Obata Kenji, and Julia Shmyrova show how Ceolus™ demonstrated a very low level of nitrite and nitrate that can allow mitigating nitrosamine formation in the drug products with secondary or tertiary amines.
DRUG-ELUTING IMPLANTS - Delivery of RNAi Therapeutics Through Drug-Eluting Implants
Cyonna Holmes, PhD, Karen Chen, MS, and Brian Wilson, PhD, review how localized therapeutic delivery of these therapies through an implant provides an innovative route of administration for chronic conditions that are difficult to dose adequately.
MARKET TRENDS - The Year of Resilience & Flexibility: Six Smart Ways CDMOs Are Preparing for 2023
Carsten Press says with biopharma businesses weathering one unexpected shift after another, it’s no surprise these organizations are looking to their partner networks for one thing above all: the flexibility they need to maximize their own business resilience.
LIPID-BASED EXCIPIENTS - Misconceptions About Lipid-Based Drug Delivery
Rollie Fuller and Ron Permutt provide formulators confidence in using LBDDS as part of formulation development programs, by demonstrating their benefits and key functional mechanisms when used and addressing commonly misrepresented, misinterpreted, and misunderstood LBDDS topics.
BIOAVAILABILITY ENHANCEMENT - Solving Low Solubility Challenges to Optimize Drug Delivery Platforms
David K. Lyon, PhD, discusses how low aqueous solubility NCEs have come to define the innovative pharmaceutical pipelines and how advanced technologies are often required to overcome this issue.
PLATFORM TECHNOLOGY - An Alternative Solution for Peptide Drug Formulation
Michael Neely introduces a unique technology platform and provides examples of how it has solved difficult formulation problems while adding significant commercial value to the resulting drug products.
EXECUTIVE INTERVIEW - ICON: Transforming Clinical Trials in a Rapidly Shifting Landscape
Ute Berger, MD, President, Development & Commercialization Solutions at ICON plc, discusses how with the acquisition of PRA in 2021, it has enhanced its value proposition and how it is transforming clinical trials in a rapidly shifting landscape.
SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame
Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.
DELIVERY TECHNOLOGY - NeuroDirect™ Ketamine: Novel, Non-Systemic Topical Therapy for PTSD & Associated Intractable Depression
Ronald Aung-Din, MD, and Chantelle G. Martin, MBChB, present scientific data demonstrating how with NeuroDirect technology, the benefits of psychedelic compounds may be achieved without concern for their potential systemic effects.
EXCLUSIVE ONLINE CONTENT
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
LIPOPHILIC SALTS - Opportunities & Applications in Oral Drug Delivery
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.