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Obstacles in Drug Development and How to Overcome Them

Obstacles in Drug Development and How to…

Drug discovery and development is a complex, expensive undertaking that…

Tablet Defects and How to Overcome Them in Manufacturing

Tablet Defects and How to Overcome Them…

Oral solid dose formulations, like tablets and capsules, are the…

Understanding Bioequivalence in Generic Drug Approval

Understanding Bioequivalence in Generic Drug Approval

Well over 80% of medicine prescribed in the US by…

Integrating cGMP in Clinical Manufacturing

Integrating cGMP in Clinical Manufacturing

Quality and safety are of utmost importance, among other critical…

Essential ANDA Checklist: Key Steps to Streamline Your Filing Process

Essential ANDA Checklist: Key Steps to Streamline…

Abbreviated New Drug Applications (ANDAs) are submitted to the FDA…

What is Oral Solid Dosage (OSD): A Comprehensive Guide to OSD Formulations

What is Oral Solid Dosage (OSD): A…

Oral solid dosage (OSD) refers to a finished drug product…

Why Your Early-Stage Drug Development Needs an R&D-Focused CDMO Partner

Why Your Early-Stage Drug Development Needs an…

Early-stage drug development is best performed at an R&D-focused CDMO.…

From R&D to Quality Control (QC): Developing QC-Friendly Analytical Methods

From R&D to Quality Control (QC): Developing…

Quality control is an integral part of the drug development…

Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective Drug Development

Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective…

Drug development is a complex and highly regulated process that…

Non-Clinical (animal) IND Enabling Studies: What You Need to Know

Non-Clinical (animal) IND Enabling Studies: What You…

In drug development, IND enabling studies serve as a vital…

Key Pharmacokinetic Factors in Topical Medication Development

Key Pharmacokinetic Factors in Topical Medication Development

Topical drug products are designed to deliver active ingredient on…

Clinical Manufacturing Explained: How CDMOs Support the Development of FDA-Approved Trial Materials

Clinical Manufacturing Explained: How CDMOs Support the…

The development of clinical trial material (CTM) is a critical…

NDA vs. ANDA: A Comprehensive Guide to Key Differences, Processes, and Regulatory Requirements

NDA vs. ANDA: A Comprehensive Guide to…

A New Drug Application (NDA) and an Abbreviated New Drug…

Stability Chambers: Testing Methods, Essential Equipment, and Applications

Stability Chambers: Testing Methods, Essential Equipment, and…

Stability chambers are a must-have in pharmaceutical research and development.…

Top 7 Questions for Small Pharma and Pharmaceutical Startups to Ask When Choosing the Right CDMO Partner

Top 7 Questions for Small Pharma and…

Most pharma companies use contract development and manufacturing organizations (CDMOs)…

Semi-Solid and Semi-Liquid Dosage Forms

Semi-Solid and Semi-Liquid Dosage Forms

Semi-solid and semi-liquid dosage forms are key pharmaceutical preparations that…

The Critical Role of Formulation Development in Product Success

The Critical Role of Formulation Development in…

All medicine administered to patients must first be formulated. It’s…

The FDA’s 505(b)(2) Explained

The FDA’s 505(b)(2) Explained

Pharmaceutical innovation can stem from a variety of different facets…

What is a CDMO and Why Does Your Company Need One?

What is a CDMO and Why Does…

What is a CDMO? A CDMO, also sometimes referred to…

Permeability Enhancers for Bioavailability Improvement

Permeability Enhancers for Bioavailability Improvement

A large number of promising compounds in the pharmaceutical pipelines…

Muco-Adhesion Testing

Muco-Adhesion Testing

Muco-Adhesion and Muco-adhesive Delivery Systems Muco-adhesion refers to the adhesion…

IVRT and IVPT: Pivotal Tools in Topical Product Development

IVRT and IVPT: Pivotal Tools in Topical…

Topical products are liquid or semi-solid dosage forms applied to…

Topical Dosage Forms: Product Development Overview

Topical Dosage Forms: Product Development Overview

Topical dosage forms are medications applied directly to the body…

Heterocyclic Compounds, the Backbone of Small Molecule Therapeutics

Heterocyclic Compounds, the Backbone of Small Molecule…

In the ever-evolving landscape of pharmaceuticals and drug discovery, researchers…

Pharmaceutical Suspensions – Part 2: Formulation Development

Pharmaceutical Suspensions – Part 2: Formulation Development

Early Preformulation Studies For the development of a robust suspension…

Pharmaceutical Suspension Formulations – Part 1: An Overview of Key Advantages and Desirable Properties

Pharmaceutical Suspension Formulations – Part 1: An…

What are Pharmaceutical Suspensions Liquid oral dosage forms such as…

Buccal Delivery Systems (Part 3) – Improving Bioavailability through Buccal Route

Buccal Delivery Systems (Part 3) – Improving…

Poor bioavailability is a common problem for a majority of…

Buccal Delivery Systems | Part 2: Applications and Dosage Forms

Buccal Delivery Systems | Part 2: Applications…

Why Buccal Delivery  Buccal cavity in the mouth is an…

Buccal Delivery Systems | Part 1: Opportunities and Challenges

Buccal Delivery Systems | Part 1: Opportunities…

The buccal region is the mouth cavity offers unique benefits…

The science of pharmaceutical taste masking

The science of pharmaceutical taste masking

Taste masking is often used in the pharmaceutical industry to…

Will the US FDA accept foreign clinical trials?

Will the US FDA accept foreign clinical…

In the past, the FDA only accepted clinical studies that…

FDA approval pathways: the 505b2

FDA approval pathways: the 505b2

Pharmaceutical innovation stems from a variety of sources. Practicing doctors…

Vici can now export and import DEA schedule 1-5 controlled substances to support clinical development

Vici can now export and import DEA…

Vici Health Sciences, a customer-focused pharmaceutical CDMO that offers formulation…

Nitrosamine risk evaluation and testing, what’s next?

Nitrosamine risk evaluation and testing, what’s next?

Nitrosamine compounds have long been considered probable human carcinogens. Nitrosamines…

Creating Formulation Intellectual Property during Drug Development – FAQ

Creating Formulation Intellectual Property during Drug Development…

Why must companies consider formulation patents? Pharmaceutical drug development is…

CMO versus CDMO: what’s the difference and how this decision is make or break for early phase drug development programs

CMO versus CDMO: what’s the difference and…

Choosing the right organization to develop drugs is the single…

Focusing on medicine for patients with swallowing difficulties

Focusing on medicine for patients with swallowing…

Vici Health Sciences, a Maryland-based CDMO is pleased to introduce…

Vici now offers cGMP API and intermediates synthesis services to support phase 1 clinical and GLP nonclinical studies

Vici now offers cGMP API and intermediates…

Vici Health Sciences, a Maryland-based CDMO is pleased to introduce…

High quality formulation development upfront saves drug developers valuable time and money

High quality formulation development upfront saves drug…

Drug development leaders must consider robustness and quality initially during…

The Importance of Formulation Development in Successful Drug Development

The Importance of Formulation Development in Successful…

Formulation development is a critical part of any drug development…