FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels March 30, 2015

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First June 5, 2023

Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.

2022 Respiratory Drug Development eBook - Demand Accelerates Devices July 8, 2022

This fourth annual Drug Development & Delivery Respiratory eBook highlights the pMDI development path, as well as the importance of a holistic approach to that development that includes the patient and all stakeholders across the product’s life cycle.

FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies April 4, 2022

Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.

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.

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 DEVELOPMENT - The Role of Excipient Selection in the Development of Orally Disintegrating Tablets January 13, 2021

Torkel Gren, PhD, reviews the benefits that orally disintegrating products can bring to patients and developers and assesses the impact that excipient selection can have on the development of successful products.

2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development August 24, 2020

This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.

FORMULATION DEVELOPMENT - Formulating Immediate-Release Tablets for Poorly Soluble Drugs June 4, 2020

Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.

BIOSIMILAR DEVELOPMENT - Biosimilar Biological Products: Development & Applications March 2, 2020

Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.

2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market September 6, 2019

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.

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development April 30, 2019

Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.

TOPICAL DEVELOPMENT - Fast Tracking Your Way to Success April 29, 2019

Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.

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.

FDA UPDATE - The FDA's New Drug Approval Process: Development & Premarket Applications April 2, 2018

Kaiser J. Aziz, PhD, in this latest FDA update, emphasizes quality system approaches to the development and availability of new drug information presented in the proposed labeling of the product.

SPECIAL FEATURE - Formulation Development & Manufacturing - CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs April 4, 2017

Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

COMBINATION PRODUCTS - Device Development for Pharmaceutical & Biologic Combination Products October 4, 2016

Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.

Aptar Pharma Announces Development & License Agreement With BD September 2, 2016

SOFTGEL FORMULATIONS - Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market August 30, 2016

Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.