Search Results for: DRUG DEVELOPMENT Human Challenge Studies
Articles
Celsion Corporation Advances Proof of Concept to Non-human Primate Challenge Study Against SARS-CoV-2 With In-Process Vaccine Candidate January 31, 2022
Celsion Corporation recently announced it has engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study with Celsion’s DNA-based approach for….
EXECUTIVE INTERVIEW - Quotient Sciences: Unique Considerations & Challenges When Developing Palatable Pediatric Formulations November 30, 2021
Nazim Kanji, Executive Director, Pediatric Services at Quotient Sciences, discusses the unique considerations and challenges when developing palatable pediatric formulations, so that molecules can become cures, fast.
RespireRx Pharmaceuticals Announces Publication of Preclinical Results Supporting the Use of AMPAkines in the Treatment of Human Spinal Cord Injury November 29, 2021
RespireRx Pharmaceuticals Inc. recently announced the publication by Dr. David Fuller (University of Florida) and his colleagues of two new,...DRUG DELIVERY - CAPRO(TM): A New Advance in Polymeric Drug Delivery October 4, 2021
Bob Wieden and Chun Wang, PhD, discuss how significant challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel polymeric drug delivery platform that overcomes a great many bioavailability and delivery obstacles.
DEVICE DEVELOPMENT - Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk October 4, 2021
Nicolas Bralet and Megan Lan, MBA, MA, discuss how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
HUMAN FACTORS STUDIES - Human Factors Studies During a Pandemic: How One Company Adapted to Covid-19 Restrictions October 4, 2021
Miranda Newbery says although it is possible to carry out use risk assessments, expert reviews and device comparisons – which do not require contact with end users – these cannot fully replace first-hand user feedback.
CONNECTED DELIVERY - Five Perspectives on Connected Drug Delivery Devices October 4, 2021
George I’ons offers insight into the factors driving the development and adoption of connected drug delivery devices and examines the varying perspectives held by relevant healthcare stakeholders.
DRUG DEVELOPMENT - Simplifying the Drug Development Journey October 4, 2021
Fran DeGrazio explains how experienced and focused collaborators can provide guidance, support services, manpower, and intellect to make it easier to achieve all the goals needed in delivering a drug to a patient.
Pardes Biosciences Initiates First-in-Human Trial for PBI-0451, an Oral Antiviral in Development to Treat & Prevent SARS-CoV-2 Infections August 31, 2021
Pardes Biosciences, Inc. recently announced the initiation of a Phase 1 clinical trial, evaluating the company’s lead candidate, PBI-0451 which is being developed as a potential oral….
HOT MELT EXTRUSION - API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution August 26, 2021
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.
2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery June 29, 2021
In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs June 2, 2021
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
FORMULATION FORUM - Nanosuspension Dosage Forms: Product Development & Scale Up June 2, 2021
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
OPEN INNOVATION PLATFORM - Beyond the Rule of Five: Scouting for Novel Formulation Approaches to Enable the Subcutaneous Application of Molecules With Poor Drug-Like Properties in Preclinical Research – Facilitated Through opnMe.com June 1, 2021
Ines Truebenbach, PhD; Menorca Chaturvedi, PhD; Markus Koester, PhD; and Achim Grube, PhD, are looking for proposals that would provide innovative formulation approaches to facilitate the subcutaneous application of bRo5 molecules in a preclinical setting.
PRECLINICAL TESTING - Expanding Opportunities in Implantable Medical Devices With Optimized Preclinical Studies June 1, 2021
Jaleel Shujath outlines the growing importance of implantable devices in clinical settings and our daily lives, highlighting the current state of preclinical testing and the regulatory barriers faced by device developers.
Cocrystal Pharma Provides Update on its COVID-19 Antiviral Discovery & Development Programs May 6, 2021
Cocrystal Pharma, Inc. recently announced progress in developing broad-spectrum antiviral drug candidates that target coronaviruses including SARS-CoV-2, the coronavirus that...FORMULATION FORUM - Considerations in Formulation Development of Injectable Solutions May 3, 2021
Jim Huang, PhD, reviews how injectable solutions offer an attractive alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability as a result of bypassing the oral absorption barrier, and suitability of administration under hospital setting.
BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices March 29, 2021
Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.
AC Immune Announces New Clinical Results in Down Syndrome, Plans for Future Development of Anti-Amyloid-Beta Vaccine March 17, 2021
AC Immune SA recently announced plans to advance its novel anti-amyloid-beta (Abeta) vaccine into mid-stage clinical testing to treat and...DRUG DEVELOPMENT - Understanding & Targeting the Mechanism of Action of Developmental Disorders March 1, 2021
Michael Snape, PhD, says when identifying promising therapeutic targets for any disease or condition, including developmental disorders such as Fragile X syndrome, PMS, CDM1, and Rett syndrome, it is critical researchers work to understand the mechanism of disease and disease pathways as well as the unmet need and patient experience.
