Insights On Drug Development

  1. An Engineered Platform For High-Loaded Dosage Forms Of Amorphous Solid Dispersions 5/11/2020

    This poster outlines a novel engineered platform for the formulation of high-active-loading oral solid dosage forms containing amorphous solid dispersions (ASDs) of a rapidly crystallizing drug with a low glass-transition temperature (Tg).

  2. Combination Product Overview: Fixed Dosage 5/7/2020

    With dwindling pipelines, limited resources, & expiring patents, now, more that ever, combination products are being considered in drug development portfolios. However, regulatory hurdles, physician acceptance, and market strategy, are just a few considerations that one should address. This brief overview will cover specifics regarding fixed dosage combinations (FDC’s), and will hopefully give your company a better understanding to the challenges ahead.

  3. Formulation Selection And In Vitro Screening For Oral Bioavailability Enhancement 5/7/2020

    Oral administration of small molecules is an ongoing challenge because most new drug candidates have poor aqueous solubility. This presentation describes use of a proven model-based technology-selection method for low-solubility molecules and in vitro evaluation strategies for three challenging classes of compounds, including one with high-dose requirements.

  4. Bioavailability Enhancement: The Key To Unlocking The Potential Of Drug Development Pipelines 5/5/2020

    In this paper we look at the process CoreRx goes through when given an active ingredient with low bioavailability and four approaches that may be applied to increase the amount of the therapeutic that enters systemic circulation.

  5. uFlux In Vitro-In Vivo Correlation (IVIVC) Testing Trans-Membrane Permeation And BSC Class II Formulation Challenges 5/5/2020

    This poster focuses on methods that could discriminate against formulation differences which may not present using traditional in-vitro dissolution techniques.

  6. API In Capsule Vs. The Lost Art Of Formulation Development 5/5/2020

    Very few businesses have as specialized a set of needs as those in the pharmaceutical sector. The combination of huge product development costs, large amounts of data and intense regulatory control makes it critical for companies to have needed information as soon as possible in order to meet a varied and closely monitored set of business processes. By Todd Daviau, Ph.D

  7. Telltale Signs You’re With The Wrong CDMO 4/27/2020

    Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

  8. How To Pick The Right CDMO For Late-Phase Clinical Trials 4/27/2020

    For pharmaceutical companies without their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in developing parenteral products. This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.

  9. Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start 4/7/2020

    As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

  10. What You Need To Know About Process Characterization And Validation For Biologic Processes 4/3/2020

    Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.