Featured Articles
CLINICAL STUDY REPORTING – Assessing the Value of Interim Analyses in Clinical Trials
Paul Stark, MS, ScD, reviews how and when an interim analysis would be valuable and how, with examples and outcomes, it can be applied in a clinical trial setting.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery & Formulation Product Approvals of 2019
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
SPECIAL FEATURE – Improving Bioavailability & Solubility: Understand Your Molecule
Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.
CLINICAL TRIALS – Leaning Into Investigator Sponsored Trials
Martin Lehr, MA, says given the capital and intellectual capacity constraints within large pharmaceutical companies and start-ups, ISTs provide an important path to unlocking the therapeutic value of developmental and marketed drugs.
INTRATUMORAL DELIVERY – Combining Local & Systemic Treatments: Could Immuno-Oncology Finally Enable Local Intratumoral Delivery?
Lewis H. Bender, MA, MBA, says cancer is a local and systemic disease, and new forms of local treatment, such as intratumoral dosing coupled with systemic immunotherapy, are being explored.
DEVELOPMENT TIMELINES – Drug Development Times, What it Takes – Part 2
Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.
CONTAINER CLOSURE INTEGRITY – Mitigating Risk in Pharmaceutical Manufacturing With Visually Inspected Components
Olga Laskina, PhD, discusses visible particles and manufacturing defects of the packaging components as well as the impact these defects can have on container closure integrity and functional characteristics.
EXECUTIVE INTERVIEW – Noxopharm: Introducing a Novel & Potentially Transformative Drug Candidate in the Treatment of Cancer
Graham Kelly, Founder, Executive Chairman, and CEO of Noxopharm, discusses the company’s innovative approach to cancer treatment.
BIOSIMILAR DEVELOPMENT – Biosimilar Biological Products: Development & Applications
Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2019 product approvals.
EXCLUSIVE ONLINE CONTENT
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.