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RISK MANAGEMENT - FDA’s Quality Risk Management Approach to New Drug Applications April 1, 2019
Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.
SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing January 10, 2019
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
TOPICAL DELIVERY - Novel Approaches to Topical Antibiotics Promise Innovation in the Treatment of Acne & Rosacea January 8, 2019
Scott Herron, MD, PhD, indicates dermatologists and their patients need a better way to deliver antibiotics effectively without contributing to the resistance problem, and an ideal solution might be a new topical antibiotic formulation.
CONTROLLED RELEASE - Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens August 27, 2018
Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.
SOLID FORM SCREENING - Phase Appropriate Strategies for Solid Form Discovery & Development May 31, 2018
Pingyun Chen, PhD, describes a rational, fit-for-purpose strategy for solid form screening and selection to ensure a successful yet cost-effective progression of drug candidates from discovery, clinical trials, and commercialization.
Helsinn Group Announces First Patient Enrolled in Phase 3b Study of NEPA IV Versus NEPA Oral March 20, 2018
Helsinn recently announced that the first patient has been enrolled in a Phase 3b study to assess the safety and...SPECIAL FEATURE - Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges March 14, 2018
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
PACKAGING - Child-Resistant Features for Container Closure Systems January 8, 2018
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
ONCOLOGY DIAGNOSTICS - Advancements Paving the Way for More Tailored Drugs November 20, 2017
Divyaa Ravishankar, MS, says pharmaceutical companies have been subjected to a wide variety of external forces compelling them to get innovative about development of new platforms, liaise with new partners, leverage big data toward precision and predictive diagnosis, and identify new markers.
KemPharm & Genco Sciences Announce Technology Licensing Agreement October 5, 2017
KemPharm, Inc., a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, recently announced it has...LIPID-BASED DELIVERY - Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox? September 29, 2017
Jason M. LePree, RPh, PhD, reviews the causes of poor bioavailability for drugs and provides an introduction to lipid-based drug delivery systems, and how the formulation approach can be used to overcome impediments to good bioavailability of therapeutic actives.
Vectura Group Launches Utibron Neohaler in the US April 10, 2017
Vectura Group plc recently announced that Sunovion Pharmaceuticals Inc. has launched Utibron Neohaler (indacaterol/glycopyrrolate) in the US. Sunovion entered into...SPECIAL FEATURE - Bioavailability & Solubility: New Approaches to Enhance Drug Performance February 27, 2017
Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.
SPECIAL FEATURE - Analytical Testing: Market Drivers, Growing Demand & Client Needs January 17, 2017
Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.
SPECIAL FEATURE - Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality June 2, 2016
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
SPECIAL FEATURE - Analytical Testing: Using More Sophisticated Tools to Support Small & Large Molecule Projects January 8, 2016
Contributor Cindy H. Dubin recently spoke with leading analytical testing providers to find out what services they offer and what equipment they use to handle both small and large molecules for their pharma clients.
UPM Pharmaceuticals Seeking to Fill 8 Positions November 23, 2015
Qualified candidates please reference job title and email resume and salary requirements to:humanresources@upm-inc.com UPM Pharmaceuticals, Inc. (www.upm-inc.com), a growing...SYRINGE SYSTEM - The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies October 5, 2015
John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.
TASTE-MASKING - Pharmaceutical Taste-Masking Technologies June 30, 2015
Suniket Fulzele, PhD, and Sarah Rieschl present an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms.
PDC*line Pharma Receives Advanced-Therapy Medicinal Product Classification for New Class of Therapeutic Cancer Vaccines June 18, 2015
PDC*line Pharma recently announced that PDC*vac, its new class of therapeutic cancer vaccines based on a line of Plasmacytoid Dendritic...
