The Altus Advantage

The Altus Advantage

The Altus Advantage

Lab to Clinic to Market

API Supply

Formulation Development Services

Preclinical Testing and Lead Selection Services

First in Human (FIH) Studies Services

Launch and Commercial Supplies Services

Launch and Commercial Supplies Services

About Altus
Drug Development

Altus Formulation is a drug formulation and development company leveraging our patented drug delivery technologies to provide innovative, cost-effective and safer to use formulations for our clients and their patients.

FAQs about Preclinical Testing

What are clinical supply services?

Clinical studies are part of the drug development process. Each clinical trial may require different amounts of drug product, in different doses and different packaging configurations sent to different clinical sites at different times. It’s a complex process that is often global.

Companies such as Altus offer more than simple clinical trial batch manufacturing, though this is an important aspect. Services also include development of your different clinic formulations, development of your manufacturing process to meet the evolving needs of your product, packaging solutions in bottles and blister packs to meet clinical study designs, and shipment to your test site. The ability to generate the stability data you need over the length of your clinical study is another crucial aspect for which Altus can support you.

What are the challenges of clinical supplies?

Efficient inventory management of clinical supplies

A good supply strategy for clinical trial products should optimize the quantity of inventory and its delivery methods in order to ensure the clinical research team has all the necessary supplies at the right time. Clinical supplies are expensive but crucial to your business. Working with Altus ensures cost-effective use of your funds to complete your trials on time.

Handling requirements of biopharmaceutical products and samples

Investigational Medicinal Products (IMP) samples are highly regulated products, even when it comes to their labelling and packaging, which can be challenging for businesses and costly in the event of mistakes. This is increased by the increase in global sourcing of supplies. There are also the challenges associated with used materials and hazardous waste produced during the various trials and studies, which need to be disposed of appropriately to ensure the safety of all.

What are the clinical phases?

Clinical phases are well-defined steps in the testing of a new drug on human subjects, although there can be some overlap within the phases. They are designed to be a safe incremental way of assessing drug safety and efficacy.

Clinical Phase I

Clinical testing starts at Phase I, where a new drug is administered to a small number of healthy test subjects. Phase I studies are performed primarily to measure the safety and tolerability of the new compound, starting at low doses and then increasing to cover the doses expected to be efficacious. Compounds may be tested in Ph II studies if they are shown to be safe in Phase I.

Clinical Phase II

Phase II trials involve larger but still relatively small groups, however, here they are not healthy subjects but patients, i.e. those suffering from the condition the new drug is intended to treat. The purpose of Phase II studies is to determine which doses of the new drug are effective in the human patients while also collecting additional safety data.

Clinical Phase III

Phase III trials are performed to assess whether the doses of drugs shown to be effective in Phase III still show efficacy when given to large groups of patients. The safety of the drug during and well after the studies is also assessed in these larger patient groups. Multiple Phase III studies in different patient populations are often required by regulatory authorities like the FDA if the drug is to be approved for sale. Phase III studies can be long and expensive.

Clinical Phase IV

Phase IV studies occur after the drug is approved for sale (so-called post-marketing studies) and they are designed to gather more long-term safety data (so-called safety follow-up studies) in the initial patient population and perhaps in new patient populations untested in the Phase III trials. Phase IV studies can support adding new claims to the product label to widen the benefit of a new drug.

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