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505(b)(1) vs 505(b)(2): Understanding the Key Differences…
The 505(b)(1) pathway is typically used for new drugs with…
Patient Compliance Through Drug Delivery Systems
Lack of patient compliance in medication is a major cause…
What is CMC?
In the pharmaceutical industry, CMC stands for Chemistry Manufacturing and…
Frequently Asked Question: Dissolution testing
Dissolution testing of pharmaceutical drug products is one of the…
Controlled Release Explained
Controlled Release (CR) involves the application of one or more…
Obstacles in Drug Development and How to…
Drug discovery and development is a complex, expensive undertaking that…
Tablet Defects and How to Overcome Them…
Oral solid dose formulations, like tablets and capsules, are the…
Understanding Bioequivalence in Generic Drug Approval
Well over 80% of medicine prescribed in the US by…
Integrating cGMP in Clinical Manufacturing
Quality and safety are of utmost importance, among other critical…
Essential ANDA Checklist: Key Steps to Streamline…
Abbreviated New Drug Applications (ANDAs) are submitted to the FDA…
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…
Early-stage drug development is best performed at an R&D-focused CDMO.…
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 is a complex and highly regulated process that…
Non-Clinical (animal) IND Enabling Studies: What You…
In drug development, IND enabling studies serve as a vital…
Key Pharmacokinetic Factors in Semi Solid Topical…
Topical drug products, which are typically semi solid dosage forms,…
Clinical Manufacturing Explained: How CDMOs Support the…
The development of clinical trial material (CTM) is a critical…
NDA vs. ANDA: A Comprehensive Guide to…
A New Drug Application (NDA) and an Abbreviated New Drug…
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…
Most pharma companies use contract development and manufacturing organizations (CDMOs)…
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…
All medicine administered to patients must first be formulated. It’s…
The FDA’s 505(b)(2) Explained
Pharmaceutical innovation can stem from a variety of different facets…
What is a CDMO and Why Does…
What is a CDMO? A CDMO, also sometimes referred to…
Permeability Enhancers for Bioavailability Improvement
A large number of promising compounds in the pharmaceutical pipelines…
Muco-Adhesion Testing
Muco-Adhesion and Muco-adhesive Delivery Systems Muco-adhesion refers to the adhesion…
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 are medications applied directly to the body…
Heterocyclic Compounds, the Backbone of Small Molecule…
In the ever-evolving landscape of pharmaceuticals and drug discovery, researchers…
Pharmaceutical Suspensions – Part 2: Formulation Development
Early Preformulation Studies For the development of a robust suspension…
Pharmaceutical Suspension Formulations – Part 1: An…
What are Pharmaceutical Suspensions Liquid oral dosage forms such as…
Buccal Delivery Systems (Part 3) – Improving…
Poor bioavailability is a common problem for a majority of…
Buccal Delivery Systems | Part 2: Applications…
Why Buccal Delivery Buccal cavity in the mouth is an…
Buccal Delivery Systems | Part 1: Opportunities…
The buccal region is the mouth cavity offers unique benefits…
The science of pharmaceutical taste masking
Taste masking is often used in the pharmaceutical industry to…
Will the US FDA accept foreign clinical…
In the past, the FDA only accepted clinical studies that…
FDA approval pathways: the 505b2
Pharmaceutical innovation stems from a variety of sources. Practicing doctors…
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 compounds have long been considered probable human carcinogens. Nitrosamines…
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…
Choosing the right organization to develop drugs is the single…
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…
Vici Health Sciences, a Maryland-based CDMO is pleased to introduce…
High quality formulation development upfront saves drug…
Drug development leaders must consider robustness and quality initially during…
The Importance of Formulation Development in Successful…
Formulation development is a critical part of any drug development…