7-8-9, Urban Ville, Nr. Vadodara Cricket Academy, Opp. Turf 106, Sevasi Link Road, Vadodara

+91 74339 89788

hospital@ahcpl.org

Our Specialities

BA-BE Studies
(100 Beds Facility)

Phase - 1 Facility (14 Beds)

Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. It is measured by comparing the ratio of the pharmacokinetic variables for the innovator versus the generic medicine where equality is 1.

  • Food effect studies
  • Gender effect studies
  • Drug - Drug integration studies
  • New drug delivery systems

All Phases Of Clinical Trials

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.

  • You may be able to get information about support groups and resources.
  • Primary way that researchers find out if a new treatment
  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.

Renal Impairment Studies

Renal impairment denotes the kidney's inability to perform its job. This situation can occur for a number of reasons, including the introduction of something into the blood that the kidney cannot expel from a person's system.

  • Diuretics & Beta blockers.
  • Vasodilators.
  • Non-steroidal anti-inflammatory drugs.
  • ACE inhibitors.

Metabolic Studies

Metabolic studies have essential roles in understanding metabolic activity of yeast cells under normal as well as in stress conditions like starvation, alkaline pH, oxygen depletion, and high temperatures.

  • Thin, lean body
  • Flat chest
  • Small shoulders
  • Not muscular

Bio Similars

Biosimilars use the exact same starting materials and similar manufacturing processes as the original biologic. They are designed and developed to be highly similar to the original drug upon which they are based, and they will not be approved as a biosimilar if they are not.

  • Biocon.
  • Boehringer Ingelheim
  • Celltrion.
  • Coherus Biosciences

Phase 1 Clinical Trials

The main aim of phase 1 trials is to find out about doses and side effects. They need to do this first, before testing the potential new treatment to see if it works. Some people taking part may benefit from the new treatment, but many won't.

  • Phase I trials test if a new treatment is safe and look for the best way to give the treatment.
  • Placebos inactive treatments are not used in phase I trials.
  • Phase I trials usually include a small number of people .
  • Phase I trials most often include people with different types of cancer

Hepatic Impairment Studies

The liver is responsible for the metabolism and clearance of many different drugs and their metabolites. Because of the liver's importance in removing drugs from the body, diseases or injuries that impair liver function (hepatic impairment) can affect how some drugs interact with the body.

  • Acetaminophen overdose
  • Prescription medications
  • Herbal supplements
  • Hepatitis and other viruses
  • Toxins

Proof Of Concept Studies

Proof-of-concept studies are typically early-stage clinical trials conducted to understand whether an investigational product elicits a pathophysiologic signal, that is, does it produce the expected response in individuals.

The overall goal is to simplify complex information or ideas visually. Concept models close the gap between requirements and planning, between stating the problem and solving the problem. It establishes a consolidated holistic view of what the project is, what it does and the users it will help.

QTc Studies

The “thorough QT/QTc study” is intended to determine whether the drug has a threshold pharmacologic effect on cardiac repolarization, as detected by QT/QTc prolongation.

The goal of QTc screening in this setting is not to identify patients whom are not candidates for therapy, but to identify those who are at increased risk for torsades de pointes so aggressive countermeasures may be implemented