An IQ Working Group developed and conducted a survey across multiple biopharmaceutical companies in early 2020 in order to gain information about design options...

This webinar will be focused on highlighting formulation, process and manufacturing challenges for vaccine development and present case studies to illustrate the...

This webinar will cover the utility, promises, and challenges in using biomarkers of nephrotoxicity.

This presentation will compare pharmacokinetic advantages of nasal powder formulations to aqueous formulations. Formulation and invitro performance attributes for...

Phase 0 approaches — which include microdosing — evaluate subtherapeutic exposures of new drugs in first-in-human studies known as exploratory clinical trials. Recent...

​The objective of this webinar is to give an overview of the methodological basis of population PK and PBPK and how it relates to pediatric drug development. A few...

The objective of this webinar is to illustrate various elements considered in regulatory assessment with respect to BE demonstration of additional strengths for which...

This webinar is being submitted as part of a series of three webinars “Pediatric Biopharmaceutics." Each of the three webinars will have two sections, for a total of...

Identification and Quantitation of Oligonucleotides and their Impurities using High-resolution Accurate-mass LC-MS

LBA/LC-MS/MS hybrid workflow is more sensitive and consistent than traditional methods, which is critical in efficacy and safety testing

This webinar is being submitted as part of a series of three webinars “Pediatric Biopharmaceutics." Each of the three webinars will have two sections, for a total of...

During this webinar, we will discuss a number of these techniques, such as XRPD, DSC, DVS, and isothermal and solution calorimetry, and highlight their respective...

This presentation will explore how to receive feedback non-defensively. Receiving critical feedback can result in normal emotional reactions such as: surprise,...

With regulatory requirements, validation protocol, and data integrity all being in the forefront, it is important to equip the laboratory with more than just...

Mass Spectrometers typically lend themselves to achieve higher throughputs but are being slowed by upfront chromatography or sample preparation.

The unprecedented vaccine and therapeutic development efforts in response to the COVID-19 pandemic have created an urgent need for rapid, accurate, and sensitive...

This webinar will introduce the overall webinar series and cover high-level objectives of product design for pediatric therapies, with a focus on clinical and patient...

In this webinar, PRA scientists will summarize some recent developments in the way the bioanalytical community feels about measurement of biomarker samples.

With the complexities involved in the safe handling of potent molecules and increasing regulatory requirements, it is imperative to choose the right partner for the...

When producing a quality vaccine, all manufacturers must confirm the purity as well as the stability of their formulation and final product

Nanotechnologies have a significant impact on the quality of life of millions of patients since the introduction of the first commercial product, Ambisome™ & Doxil™ in...

Gene expression biomarkers are now available for application in the identification of genotoxic hazards. The TGx-DDI transcriptomic biomarker can accurately...

This webinar will provide the overall development process of selecting biomarkers, which will potentially replace the current 2-year study requirement for...

We will discuss the overall trends relating to Data Integrity, independent of instrument type or potential solution. Our goal is to create a platform for a high-level...

Preclinical evaluation of cell and gene therapy (CGT) products in vitro and in vivo contributes significantly to characterization of the product benefit versus risk...

COVID19 has increased global interest in methods to deliver test articles (TAs) (e.g. AAVs, siRNAs, proteins, small molecules, etc.) locally to the lung parenchyma. ...

Dissolution is one of the first methods applied in formulation development to gain information on the expected in-vivo performance of the pharmaceuticals. Nanoparticle...

This will be a scientific seminar presented by Dr. Vinay Prasad. It will provide keen insights on cancer drug development, pitfalls in current clinical trial designs...

Join four experts who are part of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) working group intricately involved in the...

This presentation will focus on 1) the biopharmaceutics and clinical pharmacology studies needed to support the approval of repurposed drug products administered...

The extent of physicochemical degradation of drug products depends on factors such as product stability, how a product is stored, and how it is packaged. During the...

The first atomic movie of strongly driven phase transitions revealed the means to limit nucleation growth and associated shock wave damage. This insight has led to the...

As a direct mass spectrometry, Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) is a novel tool to breath analysis and early-stage drug research. With SIFT-MS, the...

In this webinar, the presenter will review a few case studies around lipid degradation, size distribution measurements, and filtration unit operations largely made...

This webinar provides a review of microencapsulation technologies that could be used in producing sustained-release microparticles for liquid suspensions, including...

. This Chalk Talk will focus on a therapeutic company’s pivot from an internal focus on a clinical development pipeline to serving a need for the global community:...

LinkedIn is the most popular social media platform among AAPS members. Arlene Padron of Simulations-Plus reviews a few actual LinkedIn profiles to help you revise your...

This webinar is intended to provide the audience with an introductory knowledge of the promise of lipidomics and its inherent challenges as well as providing resources...

For a half-century clearance concepts have been utilized in pharmacokinetics to understand the relationship between the dose administered and the time-course of...

In this webinar, the presenter will introduce the new IVIVE approach and compared its prediction performance with five literature in vitro prediction approaches.

During these unprecedented times, it’s important to keep your drug development program moving toward approval. This session will highlight strategic actions to take...

This presentation will discuss the fundamental formulation and processing considerations for obtaining a high-performing and physically- and chemically stable...

The Horizon® system from Halo Labs is the industry’s first analytical system to address the need for rapid, comprehensive subvisible particle analysis even when...

In this webinar, the presenter will discuss strategic planning and selection of a high-quality bioanalytical lab that has experience and technological capabilities to...

In this webinar, you will practice simple exercises to develop a more clear, confident, and engaging voice; master 3 easy steps to engage a complete stranger in a...

This webinar will focus on the promise of this therapy, process development and scale up approaches, challenges in analytics, and cryopreservation formulation...

The U.S. Food and Drug Administration approved labels for all drug and biologic products include extensive information on patient populations, disease indications and...

During this webinar, we will address the reasons for API instability including heat, oxidation, pH, light, and moisture; what methods may be used to impact the...

In this webinar, we will describe the most commonly used statistical approaches, using examples to highlight their applicability in different comparability scenarios....

Attend this webinar and learn the one tool that will help you more than any “elevator pitch” or “30-second commercial.” (Because, really, who has time for those?)

This will be a series of rapid fire presentations similar to the format used in PharmSci 360. A 10 minute presentation with a 3 minute Q&A. The topics were selected...

​Information doesn’t sell itself. That is the presenter’s job. In this webinar, he will draw upon some of the principles explained in his forthcoming book, The...

In this webinar, Dr. John J. Rhoden will discuss a conceptual and mathematical model of multivalent antibody binding to cell surface antigens. This model predicts that...

This webinar will discuss how Microfluidic Modulation Spectroscopy (MMS) can be used to understand the secondary structures of proteins, specifically monoclonal...

In this webinar we will begin with a refresher of linear regression as applied to stability study data, and from there take a deeper dive into the meaning of...

This webinar will discuss the AQbD roadmap and the timing and categories of statistical methods to apply. This is the third lecture in a series of webinars brought to...

Pharma companies are under intense pressure to get products to market faster than ever in order to drive profits and deliver value to their customers. ...

In this webinar, the powerful, yet relatively simple, statistical tools and approach of exploratory data analysis (EDA) are introduced. This is the second lecture in...

This webinar will provide an overview of the basic principles of DOE, demonstrate the many scientific and business benefits of DOE, and dispel some common myths...

Due to the increasing complexity of biopharmaceuticals, development of a drug product can be a major challenge. Issues include chemical and physical degradation that...

In this webinar, translational strategies for prediction of human linear PK of mAbs, including use of typical human popPK parameters and allometric exponents from...

This is LECTURE 2 in the Emerging Modalities series. To register for Lecture 1 in the series visit https://www.pathlms.com/aaps/webinars/4920

This webinar is brought to you by Chemspeed Technologies. Discover innovative examples of how complex workflows in the pharmaceutical R&D industry can be optimized...

This webinar will present the key properties of a drug product that influences disintegration behavior and discusses how these are related to the dissolution performance.

The immunomodulatory biologics are designed to engage immune cells to support the effective killing of targeted cancer cells. In this lecture, the speaker will...

Join Martin Daunbey as he takes a deep dive into various belief systems regarding stress, how these beliefs develop, and how to adjust beliefs to support a winning...

In his presentation, David gave attendees three tools to help them have a more productive conversation about the value of their work. Anyone who struggles to convey...

Discover the ways your Quality Control Department can embrace opportunities to use digital technology as a way to implement process changes to make workloads easier,...

In this webinar, explore TKC with pharmaceutical polymers in ASD formulations and see how they create new opportunities for differentiated drug products.

Many scientific presenters are so enamored of their data that they forget they are there to serve their audience members! As a moderator, your role is to help the...

Join us for this exciting webinar as the experts from Death by PowerPoint share strategies on how to create informative, visually intriguing PowerPoint presentations...

Review the process for viral inactivation of clarified harvest using the detergent Octyl-D-glucopyranoside (ODG).

This webinar will provide the regulatory pathways for genomics and targeted therapies.

The primary goal of this webinar is to review the state-of-the-art developments in the nanomedicine, discuss the pros and cons of different approaches, and examine...

An introductory session to provide a basic understanding of Pharmacogenetics.

2017, the next five years, and beyond.

Regulatory requirements with regard to extractables and leachables.

This webinar will provide an overview of a recent research project.

Learn the primary mechanisms of aerosol generation used in nebulization, namely, air jet, ultrasonic, and vibrating mesh nebulization.

A panel of industry, regulator, and academic experts to discuss lessons learned from the previous cases and steps to consider when developing QSP models.

The 5th live event in the Personalized Medicine series.

Siscuss and debate such aspects from industrial and regulatory perspective and would help to exchange of ideas to move the field further.

The 4th live event in the Personalized Medicine series.

The 3rd live event in the Personalized Medicine series.

Why can’t I have drug disposition just like Mom and Dad? Understanding the impact of transporter and enzyme ontogeny in pediatrics.

The 2nd live event in the Personalized Medicine series.

How microsampling is being used to in the quantitation of drugs, metabolites, and biomarkers in preclinical and clinical development.

Monitoring manufacturing and laboratory processes under continued process verification.

The 1st live event in the Personalized Medicine series.

Introduce formulation scientists, device engineers, and other pharmaceutical professionals to the core technical considerations of respiratory drug delivery.

Progress drug discovery candidates from any pharmaceutical organization to development with low risk that provide a balance of speed and quality.

A fresh perspective on networking for introverts and extroverts alike. Get the most out of your networking opportunities!

A discussion among leading experts who have successfully applied these advanced novel analytical technologies in pharmaceutical impurities analysis.

Prepare yourself to participate in the public arena where science is often met with skepticism.

What does one do when spray-drying and melt-extrusion fail to meet the drug product needs for their compound? Join us!

Get the basics here and then a deeper, hands-on experience at the 2017 Annual Meeting!

Explore the regulatory path-way for the approval of combination products and the unique challenges.

Address the current gap in the field of impact assessment of clinically relevant immunogenicity as it relates to impact on safety.

An exploratory assessment of the topic.

Learn how to focus on the needs of a live audience, not an imagined reader, when preparing and delivering a scientific presentation.

Current methods and state-of-the-art approaches.

Discuss current issues related to the use of surfactants in parenteral formulations.

Experts discuss these draft guidelines and highlight their similarities, differences, and major issues.

Understand and discuss protein formulation and analytical development.

The focus of this event will be to share in more detail specifics of each ICH Q&A and an update on the status of the guideline.

Review the state-of-the art nature of this field; pros and cons of different approaches and how these systems will have consequences.

Highlight the three winning research articles from the PPB Student Committee implemented a Best Student/Postdoc Manuscript Contest.

Can you See what I See? As modeling becomes more and more powerful and should be seen as the future for oral drug development.

Discuss the new FDA guidance and interact with scientists to discuss the consequences to industry.

The do’s and don’t’s from effective job search to durable career development.

Everything you need to know about Japan's new drug application-specific bracketing strategies.

Understand the principles and applications of primary 3D micro-imaging technology.

Come discuss six LBA methods validated either in house or at a CRO to support bioanalysis for GLP toxicokinetic or clinical pharmacokinetic studies.

Hear the arguments for each side of this debate and decide who wins your vote!

Exploring the pre-clinical and translational development of therapeutic antibodies.

How to Utilize Current Technology in Designing Successful Characterization and Control Strategies.

New methodologies in intrinsic clearance measurement, reaction phenotyping, and metabolite identification for low clearance compounds.

Monitor particulate matter in parenteral drug products.

A discussion on emerging trends in antibacterial drug research.

Demise of the heavy metals approach and implementation of ICH Q3D and USP <232> and <233>: considerations and challenges.

Transporter changes in the setting of liver disease can lead to clinically significant changes in drug disposition.

Faster and better evaluation and prediction of formulation properties and the improvement of biopharmaceutical development.

Discuss the challenges encountered with multiplex LBAs, the underlying causes, and explore tangible solutions.

How to design and execute manipulation and extraction studies.

Recommendations from the AAPS Biosimilars Committee and reflections on regulatory feedback.

A discussion of the recent FDA guidance with a focus on safety.

Focus on the CMC considerations for the development, manufacture, and characterization of Bi-specific Abs.

Explore statistical evaluation of critical quality attributes (CQAs), which define the purity, potency and safety of a protein therapeutic, for the purpose of...

Paradigm-shifting innovations to assess OATP DDI liabilities.

Regulatory Requirements, Testing Concepts and a Holistic Approach to Designing a High-Quality Container Closure System.

Disscuss recent innovative applications of LC/MS for ADA measurement in drug discovery and development and case studies to provide some insight of this new technology.

Preformulation considerations for development of extemporaneous on-site compounded (OSC) drug in bottle (DIB) formulations.

Drug Application Webinar Series: Type II Drug Master Files – API Submissions

Join us and learn the art of selling your science!

A hands on experience with the BioRAM tool and Q&A with the experts.