Stuart R. Gallant, MD, PhD There are 20,000 to 25,000 prescription and OTC medications licensed in the United States, and every year there are about…
Tag: Clinical
Pharmaceutical Process Scale-Up
Stuart R. Gallant, MD, PhD A friend of mine who has been employed in pharmaceutical manufacturing for decades has a saying regarding process scale up. …
AI in Pharma R&D and Manufacturing
Stuart R. Gallant, MD, PhD Artificial intelligence is being widely adopted in fields like law, accounting, banking, customer service, marketing, and human resources. These early…
Approval Rate and Development Cost by Drug Category
Stuart R. Gallant, MD, PhD Takeda just announced that it would exit cell-based treatment research [1]. Last year, Takeda had ended development of its non-Hodgkin…
Contract Manufacturing in the Age Tariffs
Stuart R. Gallant, MD, PhD Almost three years ago, PharmaTopo carried a post describing the process of selecting and working with a contract manufacturer [1]. …
Challenges in Sterile Filling
Stuart R. Gallant, MD, PhD Parenteral products require sterility whether they are liquid vials, lyophilized vials, or prefilled syringes. This week’s post on Pharmatopo addresses…
Pharmaceutical Shelf-Life Determination
Stuart R. Gallant, MD, PhD Pharmaceutical shelf-life determination affects patient safety by assuring that the strength, quality, purity, and potency of an investigational or commercial…
3 Dimensions of Early Pharmaceutical Formulation
Stuart R. Gallant, MD, PhD In the pre-clinical phase of pharmaceutical development, the project team wants to demonstrate drug efficacy in animal models, as well…
Selecting an Analytical Laboratory
Stuart R. Gallant, MD, PhD Analytical testing is required to verify the identity, strength, quality, purity, and potency of investigational and commercial products. The precise…
Preparation of an Investigational New Drug (IND) Application
Stuart R. Gallant, MD, PhD A pharmaceutical company begins development of a new drug by screening dozens or even thousands of molecules to find the…
The 4 Axes of Drug Development Readiness
Stuart R. Gallant, MD, PhD In the earliest stages of drug research, scientists conduct bench experiments at a university or in a corporate pharmaceutical research…
Wound Care and Healing
Stuart R. Gallant, MD, PhD CAVEAT: THIS POST INCLUDES PHOTOGRAPHS OF TISSUE INJURIES AND MAY CAUSE SOME READERS DISCOMFORT. An 81-year-old, retired accountant is on…
Trends in Pharmaceutical Autoinjector Design and Use
Stuart R. Gallant, MD, PhD In today’s post, some important aspects of development and manufacture of combination products with pharmaceutical autoinjectors are considered. Pharmaceutical autoinjectors…
Skin pH, Water Content, and Water Loss
Stuart R. Gallant, MD, PhD Our skin does so much for us. Skin protects us against infection and dehydration. Skin allows us to be in…
Oral Delivery of Protein Drugs
Stuart R. Gallant, MD, PhD Proteins and peptides are commonly delivered subcutaneously and by infusion; however, these approaches have disadvantages. Among the chief problems are:…
Immediate, Delayed, and Extended-Release Drug Products
Stuart R. Gallant, MD, PhD The focus of today’s post is oral drug release—immediate, delayed, and extended. Many technologies exist for controlling drug release—the focus…
Vaccines for Lyme Disease
Stuart R. Gallant, MD, PhD In 1991, Helmut and Erika Simon, two German tourists hiking in the Alps near the Austrian/Italian border when they saw…
Anti-TNF Medications
Stuart R. Gallant, MD, PhD I have a weakness for old Hollywood movies. The movie still that appears above this paragraph depicts John Carradine in…
Pharmaceutical Patent Strategy
Stuart R. Gallant, MD, PhD When I think of patent law, I am reminded of a line from the play A Man for All Seasons. …
Moderna’s Bivalent Booster
Stuart R. Gallant, MD, PhD Back in April, PharmaTopo posted on lipid nanoparticle formulations for Covid-19 vaccines [1]. Because the Moderna bivalent vaccine recently arrived…
Pharmaceutical Design Focus: Clot Busters (2 of 2)
Stuart R. Gallant, MD, PhD In the first part of this post, we looked at urokinase. In the second part, we will look at tissue…
Pharmaceutical Design Focus: Clot Busters (1 of 2)
Stuart R. Gallant, MD, PhD This November will be the 35th anniversary of the approval of tissue plasminogen activator (tPA, alteplase) a leading treatment for…
Pharmaceutical Decision Making and Fundraising
Stuart R. Gallant, MD, PhD Within pharmaceutical development, there are two types of go-no-go decisions: 1) clinical and 2) financial. These decisions are linked together…
Treatments for Alzheimer’s Disease (2 of 2)
Stuart R. Gallant, MD, PhD Having discussed the pathological processes of Alzheimer’s disease in the first part of this post, the current status of Alzheimer’s…
Treatments for Alzheimer’s Disease (1 of 2)
Stuart R. Gallant, MD, PhD One of the most useful words in medicine is “multifactorial.” Commonly, in science and medicine, we struggle to find a…
Pharmaceutical Design Focus: Factor VIII (2 of 2)
Stuart R. Gallant, MD, PhD In the first part of this two-part post, we looked at the biochemistry of clotting factor Factor VIII and the…
Drug Development Plan
Stuart R. Gallant, MD, PhD How A Drug Development Plan Originates Keller and Schnell suggest that there are five challenges to a pharmaceutical startup: 1)…
Intellectual Property (2 of 3)
Stuart R. Gallant, MD, PhD Licensors and Licensees As discussed in Part 1 of this three-part series, drug development and licensing has taken on the…
Cost of Pre-Clinical Development (1 of 3)
Stuart R. Gallant, MD, PhD In the last three decades, how pharmaceutical drug development occurs has changed dramatically. Prior to this change, a significant share…