This document discusses the FDA's guidance on assessing the abuse potential of drugs. It outlines how the FDA evaluates eight factors to determine if a drug has abuse potential and should be classified as "abuse liable." Key animal studies for abuse liability screening include drug discrimination and self-administration tests. Drug discrimination assesses if a novel drug produces effects similar to abused reference drugs, while self-administration tests if animals will voluntarily take a drug, indicating its abuse potential. Sponsors must submit results of abuse potential studies to the FDA for review.
This document describes an experiment to estimate the unknown concentration of an acetylcholine solution using hen's ileum tissue in an interpolation bioassay. The experiment involves mounting hen's ileum tissue in an organ bath, exposing it to solutions of known acetylcholine concentrations to generate a standard concentration-response curve, and then exposing it to the test solution to interpolate its concentration based on the curve. Key steps include tissue stabilization, adjusting basal tension, exposing tissues to different acetylcholine concentrations to create the standard curve, exposing to the test solution, measuring responses, plotting the curve, and calculating the concentration of the unknown based on its response. The aim is to estimate unknown drug concentrations using a reliable and less time-consuming interpolation bioassay
Expt 8 Effect of drugs on ciliary motility of frog oesophagusMirza Anwar Baig
This document outlines a study to examine the effect of various drugs on gastrointestinal motility using frogs. The study will use physostigmine and atropine solutions applied to the buccal cavity of frogs to measure the time taken for food particles to move from the lower jaw to the esophagus, compared to a saline control. The goal is to determine if physostigmine enhances while atropine reduces gastrointestinal motility by stimulating or blocking acetylcholine, respectively. The procedure describes preparing the frog, taking baseline measurements, then applying the drug solutions and remeasuring motility times to observe any effects.
Expt 12 Anticonvulsant effect of drugs by MES and PTZ methodMirza Anwar Baig
This document summarizes a study on the anticonvulsant effect of drugs using the maximum electroshock (MES) and pentylene tetrazole (PTZ) methods. It describes using albino rats or mice and pretreating them for 60 minutes with either a test drug like diphenyl hydantoin-Na or a saline control. The MES method uses electrodes to induce seizures resembling grand mal epilepsy, while PTZ induces seizures resembling petit mal epilepsy. The study procedure involves dividing pre-screened mice into groups, administering the test drug or saline, applying a shock after 1 hour, and recording the timing of seizure phases.
Pharmacology (effects of drugs on the ciliary motility of forg oesophagus)Osama Al-Zahrani
1) The experiment tested the effects of various drugs on the ciliary motility of a frog's esophagus, including the cholinergic agonist acetylcholine, the anti-choline esterase inhibitor physostigmine, and the cholinergic antagonist atropine.
2) The results showed that physostigmine had the strongest effect of increasing ciliary movement, followed by acetylcholine, while atropine decreased movement the most.
3) Physostigmine was determined to be the most effective drug at increasing ciliary motility based on it producing the shortest time for movements to increase.
Anti-inflammatory activity of drugs using carrageenan induced paw-edema model...Dr. Sameer H. Sawant
This document describes a study to evaluate the anti-inflammatory activity of drugs using a carrageenan-induced paw edema model in rats. The study involves injecting carrageenan into the paws of rats to cause inflammation and edema, which are measured over time using a plethysmometer. Rats are divided into control and test groups, with the test group receiving indomethacin prior to carrageenan injection. Paw volumes are measured and compared between the groups to determine the ability of indomethacin to reduce edema caused by carrageenan, demonstrating its anti-inflammatory effects.
Screening models for central and peripheral analgesicskrishnabajgire
This document describes screening models used to test central and peripheral analgesic activity. For central analgesic activity, it discusses the hot plate test, grid-shock test, and tail immersion test which measure response latency to a painful stimulus. For peripheral analgesic activity, it discusses the writhing test which counts stretching behaviors in mice after an irritant injection, and the Randall-Selitto test which applies pressure to inflamed tissue in rats to measure pain threshold changes.
To study effect of drug on ciliary motility of frog oesophagusNITINKUMARSEN
1. The document describes an experiment to study the effects of drugs on ciliary motility in a frog esophagus. Physostigmine and atropine were tested.
2. Physostigmine is a cholinesterase inhibitor that prolongs the action of acetylcholine, increasing ciliary movements. Atropine is an anticholinergic that blocks acetylcholine receptors, decreasing ciliary movements.
3. The procedure involved measuring the time taken for poppy seeds to move along the esophagus under the influence of different drugs. Physostigmine decreased transit time, while atropine increased it, demonstrating their effects on ciliary motility.
This document describes an experiment to estimate the unknown concentration of an acetylcholine solution using hen's ileum tissue in an interpolation bioassay. The experiment involves mounting hen's ileum tissue in an organ bath, exposing it to solutions of known acetylcholine concentrations to generate a standard concentration-response curve, and then exposing it to the test solution to interpolate its concentration based on the curve. Key steps include tissue stabilization, adjusting basal tension, exposing tissues to different acetylcholine concentrations to create the standard curve, exposing to the test solution, measuring responses, plotting the curve, and calculating the concentration of the unknown based on its response. The aim is to estimate unknown drug concentrations using a reliable and less time-consuming interpolation bioassay
Expt 8 Effect of drugs on ciliary motility of frog oesophagusMirza Anwar Baig
This document outlines a study to examine the effect of various drugs on gastrointestinal motility using frogs. The study will use physostigmine and atropine solutions applied to the buccal cavity of frogs to measure the time taken for food particles to move from the lower jaw to the esophagus, compared to a saline control. The goal is to determine if physostigmine enhances while atropine reduces gastrointestinal motility by stimulating or blocking acetylcholine, respectively. The procedure describes preparing the frog, taking baseline measurements, then applying the drug solutions and remeasuring motility times to observe any effects.
Expt 12 Anticonvulsant effect of drugs by MES and PTZ methodMirza Anwar Baig
This document summarizes a study on the anticonvulsant effect of drugs using the maximum electroshock (MES) and pentylene tetrazole (PTZ) methods. It describes using albino rats or mice and pretreating them for 60 minutes with either a test drug like diphenyl hydantoin-Na or a saline control. The MES method uses electrodes to induce seizures resembling grand mal epilepsy, while PTZ induces seizures resembling petit mal epilepsy. The study procedure involves dividing pre-screened mice into groups, administering the test drug or saline, applying a shock after 1 hour, and recording the timing of seizure phases.
Pharmacology (effects of drugs on the ciliary motility of forg oesophagus)Osama Al-Zahrani
1) The experiment tested the effects of various drugs on the ciliary motility of a frog's esophagus, including the cholinergic agonist acetylcholine, the anti-choline esterase inhibitor physostigmine, and the cholinergic antagonist atropine.
2) The results showed that physostigmine had the strongest effect of increasing ciliary movement, followed by acetylcholine, while atropine decreased movement the most.
3) Physostigmine was determined to be the most effective drug at increasing ciliary motility based on it producing the shortest time for movements to increase.
Anti-inflammatory activity of drugs using carrageenan induced paw-edema model...Dr. Sameer H. Sawant
This document describes a study to evaluate the anti-inflammatory activity of drugs using a carrageenan-induced paw edema model in rats. The study involves injecting carrageenan into the paws of rats to cause inflammation and edema, which are measured over time using a plethysmometer. Rats are divided into control and test groups, with the test group receiving indomethacin prior to carrageenan injection. Paw volumes are measured and compared between the groups to determine the ability of indomethacin to reduce edema caused by carrageenan, demonstrating its anti-inflammatory effects.
Screening models for central and peripheral analgesicskrishnabajgire
This document describes screening models used to test central and peripheral analgesic activity. For central analgesic activity, it discusses the hot plate test, grid-shock test, and tail immersion test which measure response latency to a painful stimulus. For peripheral analgesic activity, it discusses the writhing test which counts stretching behaviors in mice after an irritant injection, and the Randall-Selitto test which applies pressure to inflamed tissue in rats to measure pain threshold changes.
To study effect of drug on ciliary motility of frog oesophagusNITINKUMARSEN
1. The document describes an experiment to study the effects of drugs on ciliary motility in a frog esophagus. Physostigmine and atropine were tested.
2. Physostigmine is a cholinesterase inhibitor that prolongs the action of acetylcholine, increasing ciliary movements. Atropine is an anticholinergic that blocks acetylcholine receptors, decreasing ciliary movements.
3. The procedure involved measuring the time taken for poppy seeds to move along the esophagus under the influence of different drugs. Physostigmine decreased transit time, while atropine increased it, demonstrating their effects on ciliary motility.
This presentation deals with the in-depth analysis of various cardiac stimulants & depressants both directly & indirectly acting on frog's heart. Also, includes a nice quiz, a good exercise for the grey cells of the brain at the end of the presentation.
1. The aim of the experiment was to estimate the unknown concentration of an acetylcholine solution using a three point bioassay with hen's ileum tissue.
2. The three point bioassay method involves using two known concentrations of a standard drug (acetylcholine) and one unknown concentration of the test solution, with the response to the unknown concentration falling between the responses of the two standard concentrations.
3. The unknown concentration of the test solution can then be calculated using a specific formula based on the responses to the standard and test concentrations.
Pharmacology is a broad medical specialty that studies how drugs interact with living systems. It includes the study of drug synthesis, mechanisms of action, effects, and movement through the body. Some key areas are medicinal chemistry, pharmacodynamics, pharmacokinetics, chemotherapy, and toxicology. Drugs are given brand/trade names and have chemical/generic names. Pharmacists complete advanced degrees and dispense drugs through pharmacies and hospitals. Drug actions can be additive, synergistic, induce tolerance, or have idiosyncratic, side, or toxic effects. Major drug classes include analgesics, anesthetics, antibiotics, anticoagulants, antidepressants, antidiabetics, antihistamines, cardiovascular
Drug discovery clinical evaluation of new drugsKedar Bandekar
The document discusses the process of new drug development from initial idea to market launch. It takes 12-15 years and over $1 billion. The process involves identifying a biological target, screening compounds to find hits, optimizing hits to develop leads, and conducting preclinical and clinical trials. Key steps include target identification and validation, high-throughput screening to find initial hits, hit-to-lead and lead optimization processes to improve properties, and progression through preclinical and clinical phases of drug development. Characteristics of ideal lead compounds include high target affinity and selectivity, efficacy, appropriate physicochemical properties, and favorable ADME profile.
Expt. 5 Bioassay of oxytocin using rat uterine horn by interpolation methodVISHALJADHAV100
Experiment No. 5 was a bioassay to determine unknown concentrations of oxytocin using isolated rat uterine horns through an interpolation bioassay. Rat uteri were isolated and mounted in an organ bath containing De Jalon solution. A concentration response curve was established for a standard oxytocin solution and responses to test solutions were recorded. The test responses were selected such that they fell on the linear portion of the standard curve. The height of contractions were measured and used to calculate the unknown oxytocin concentrations by interpolating the test responses on the standard curve graphically. The unknown concentrations were determined to be [value 1] μg/ml from one method of calculation and [value 2] μg/ml from the other method.
This document provides an overview of various screening methods for analgesics, including animal models and in vitro techniques. It describes models of acute, chronic, cancer, and neuropathic pain using thermal, electrical, chemical, and mechanical stimuli. Animal models involve tests like the hot plate test, tail flick test, formalin test, and Randall Selitto test. The document also discusses the roles of VIP, PACAP, and nociceptin in modulating pain and their potential as analgesic targets.
Expt. 8 Effect of physostigmine on DRC of acetylcholine using frog rectus abd...VISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh and Physostigmine stock and std. solutions
Preparation of frog ringer solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation of magnification value (Mf)
Graphical presentation of CRC/ DRC
Result and interpretation
Introduction to experimental pharmacologyDigambar16
Experimental pharmacology is the branch of pharmacology that studies the effects of drugs on living organisms. It involves preclinical studies on animals to discover new drugs and determine their effects before clinical studies on humans. Preclinical studies include both in vivo experiments, which study drug effects on whole animals, and in vitro experiments, which isolate tissues and organs to study drug interactions outside of the body through dissection and isolation techniques.
Expt. 11 Determination of acute eye irritation corrosion of a test substanceVISHALJADHAV100
This document outlines the procedure for conducting an acute eye irritation/corrosion test of a substance using albino rabbits. The objective is to determine the degree of eye irritation or corrosion caused by a test substance. A single dose of the substance is applied to one eye of each rabbit, while the other eye serves as a control. Lesions to the conjunctiva, cornea, and iris are observed and graded at various time intervals over 72 hours. Based on the grading scores of the test eye compared to the control eye, the sensitization potential of the substance can be determined.
Expt. 2 Bioassay of acetylcholine using rat ileum by four point bioassayVISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh stock and standard solutions
Preparation of Tyrode solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation
Result and interpretation
This document provides information on common laboratory animals used for experimental pharmacology. It discusses rats, mice, guinea pigs, rabbits, cats, dogs, and monkeys as examples of rodents and non-rodents used. Key details are provided on the characteristics of each species. The document also covers bioassay methods, describing them as a way to measure pharmacological activity and potency through biological responses. Both qualitative and quantitative bioassays are outlined.
Expt 11 Effect of drugs on locomotor activity using actophotometerMirza Anwar Baig
This document describes an experiment to evaluate the effects of drugs on locomotor activity using an actophotometer. Rats or mice are injected with either a saline control, the antipsychotic drug chlorpromazine at 3 mg/kg, or caffeine at 3 mg/kg. Their movement is then measured in the actophotometer before and after drug administration. Chlorpromazine is expected to reduce locomotor activity as a CNS depressant, while caffeine may increase it as a CNS stimulant. The results are presented as locomotor activity scores showing that chlorpromazine decreased activity and caffeine increased it, demonstrating their respective CNS effects.
Expt. 9 Effect of atropine on DRC of acetylcholine using rat ileumVISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh and Atropine stock and std. solutions
Preparation of Tyrode solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation
Graphical presentation of CRC/ DRC
Result and interpretation
Expt. 7 Bioassay of acetylcholine using rat ileum by four point bioassayVISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh stock and standard solutions
Preparation of frog ringer solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation
Result and interpretation
This document describes different types of bioassays including direct end point assays, quantal assays, and graded assays. It provides details on graded response assays, specifically bracketing assays, matching assays, interpolation assays, and multiple point assays (3-point, 4-point, 6-point, and 8-point assays). Graded response assays involve comparing the response of a test drug to a standard drug response curve to determine the potency of the test drug. Multiple point assays take responses at different doses of both the standard and test drugs to improve accuracy over other graded response assay methods.
This topic covers drugs of Sedative & Hypnotic especially from Benzodiazepine class including drugs such as Diazepam , Nitrazepam, Lorazepam, Oxazepam etc also deals with drugs of alcohol class.
reference should be take from Med Chem by Algarswamy , Organic Chemistry by Robert Neilson Boyd and Robert Thornton Morrison or any other suitable reference book.
This document discusses sedative-hypnotic drugs. It notes that this drug classification is based on clinical uses of sedation and encouraging sleep rather than chemical structure. Common sedative-hypnotic drugs include benzodiazepines, barbiturates, and newer nonbenzodiazepine hypnotics like zolpidem, zaleplon, and eszopiclone. These drugs work by enhancing the effects of the inhibitory neurotransmitter GABA at GABA receptors in the brain. Their clinical uses include treatment of anxiety, insomnia, and as sedatives for medical and surgical procedures.
Discovery of Drug and Introduction to Clinical Trial__Katalyst HLSKatalyst HLS
This document provides an overview of the drug discovery and clinical trials process. It discusses the goals of drug discovery which include identifying new chemical entities and developing medicines to address unmet medical needs. The drug discovery process involves target identification, validation, lead generation, and optimization. Pre-clinical testing is then conducted to evaluate safety and effects. If successful, an investigational new drug application is filed with the FDA prior to beginning clinical trials. Clinical trials involve 4 phases to test safety and efficacy in humans. Upon completion, a new drug application can be filed for FDA review and potential approval.
This presentation deals with the in-depth analysis of various cardiac stimulants & depressants both directly & indirectly acting on frog's heart. Also, includes a nice quiz, a good exercise for the grey cells of the brain at the end of the presentation.
1. The aim of the experiment was to estimate the unknown concentration of an acetylcholine solution using a three point bioassay with hen's ileum tissue.
2. The three point bioassay method involves using two known concentrations of a standard drug (acetylcholine) and one unknown concentration of the test solution, with the response to the unknown concentration falling between the responses of the two standard concentrations.
3. The unknown concentration of the test solution can then be calculated using a specific formula based on the responses to the standard and test concentrations.
Pharmacology is a broad medical specialty that studies how drugs interact with living systems. It includes the study of drug synthesis, mechanisms of action, effects, and movement through the body. Some key areas are medicinal chemistry, pharmacodynamics, pharmacokinetics, chemotherapy, and toxicology. Drugs are given brand/trade names and have chemical/generic names. Pharmacists complete advanced degrees and dispense drugs through pharmacies and hospitals. Drug actions can be additive, synergistic, induce tolerance, or have idiosyncratic, side, or toxic effects. Major drug classes include analgesics, anesthetics, antibiotics, anticoagulants, antidepressants, antidiabetics, antihistamines, cardiovascular
Drug discovery clinical evaluation of new drugsKedar Bandekar
The document discusses the process of new drug development from initial idea to market launch. It takes 12-15 years and over $1 billion. The process involves identifying a biological target, screening compounds to find hits, optimizing hits to develop leads, and conducting preclinical and clinical trials. Key steps include target identification and validation, high-throughput screening to find initial hits, hit-to-lead and lead optimization processes to improve properties, and progression through preclinical and clinical phases of drug development. Characteristics of ideal lead compounds include high target affinity and selectivity, efficacy, appropriate physicochemical properties, and favorable ADME profile.
Expt. 5 Bioassay of oxytocin using rat uterine horn by interpolation methodVISHALJADHAV100
Experiment No. 5 was a bioassay to determine unknown concentrations of oxytocin using isolated rat uterine horns through an interpolation bioassay. Rat uteri were isolated and mounted in an organ bath containing De Jalon solution. A concentration response curve was established for a standard oxytocin solution and responses to test solutions were recorded. The test responses were selected such that they fell on the linear portion of the standard curve. The height of contractions were measured and used to calculate the unknown oxytocin concentrations by interpolating the test responses on the standard curve graphically. The unknown concentrations were determined to be [value 1] μg/ml from one method of calculation and [value 2] μg/ml from the other method.
This document provides an overview of various screening methods for analgesics, including animal models and in vitro techniques. It describes models of acute, chronic, cancer, and neuropathic pain using thermal, electrical, chemical, and mechanical stimuli. Animal models involve tests like the hot plate test, tail flick test, formalin test, and Randall Selitto test. The document also discusses the roles of VIP, PACAP, and nociceptin in modulating pain and their potential as analgesic targets.
Expt. 8 Effect of physostigmine on DRC of acetylcholine using frog rectus abd...VISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh and Physostigmine stock and std. solutions
Preparation of frog ringer solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation of magnification value (Mf)
Graphical presentation of CRC/ DRC
Result and interpretation
Introduction to experimental pharmacologyDigambar16
Experimental pharmacology is the branch of pharmacology that studies the effects of drugs on living organisms. It involves preclinical studies on animals to discover new drugs and determine their effects before clinical studies on humans. Preclinical studies include both in vivo experiments, which study drug effects on whole animals, and in vitro experiments, which isolate tissues and organs to study drug interactions outside of the body through dissection and isolation techniques.
Expt. 11 Determination of acute eye irritation corrosion of a test substanceVISHALJADHAV100
This document outlines the procedure for conducting an acute eye irritation/corrosion test of a substance using albino rabbits. The objective is to determine the degree of eye irritation or corrosion caused by a test substance. A single dose of the substance is applied to one eye of each rabbit, while the other eye serves as a control. Lesions to the conjunctiva, cornea, and iris are observed and graded at various time intervals over 72 hours. Based on the grading scores of the test eye compared to the control eye, the sensitization potential of the substance can be determined.
Expt. 2 Bioassay of acetylcholine using rat ileum by four point bioassayVISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh stock and standard solutions
Preparation of Tyrode solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation
Result and interpretation
This document provides information on common laboratory animals used for experimental pharmacology. It discusses rats, mice, guinea pigs, rabbits, cats, dogs, and monkeys as examples of rodents and non-rodents used. Key details are provided on the characteristics of each species. The document also covers bioassay methods, describing them as a way to measure pharmacological activity and potency through biological responses. Both qualitative and quantitative bioassays are outlined.
Expt 11 Effect of drugs on locomotor activity using actophotometerMirza Anwar Baig
This document describes an experiment to evaluate the effects of drugs on locomotor activity using an actophotometer. Rats or mice are injected with either a saline control, the antipsychotic drug chlorpromazine at 3 mg/kg, or caffeine at 3 mg/kg. Their movement is then measured in the actophotometer before and after drug administration. Chlorpromazine is expected to reduce locomotor activity as a CNS depressant, while caffeine may increase it as a CNS stimulant. The results are presented as locomotor activity scores showing that chlorpromazine decreased activity and caffeine increased it, demonstrating their respective CNS effects.
Expt. 9 Effect of atropine on DRC of acetylcholine using rat ileumVISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh and Atropine stock and std. solutions
Preparation of Tyrode solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation
Graphical presentation of CRC/ DRC
Result and interpretation
Expt. 7 Bioassay of acetylcholine using rat ileum by four point bioassayVISHALJADHAV100
Objective
Principle
Requirements
Experimental specifications (conditions)
Preparation of ACh stock and standard solutions
Preparation of frog ringer solution (PSS)
Procedure
Kymograph recording of contractions
Observation table
Calculation
Result and interpretation
This document describes different types of bioassays including direct end point assays, quantal assays, and graded assays. It provides details on graded response assays, specifically bracketing assays, matching assays, interpolation assays, and multiple point assays (3-point, 4-point, 6-point, and 8-point assays). Graded response assays involve comparing the response of a test drug to a standard drug response curve to determine the potency of the test drug. Multiple point assays take responses at different doses of both the standard and test drugs to improve accuracy over other graded response assay methods.
This topic covers drugs of Sedative & Hypnotic especially from Benzodiazepine class including drugs such as Diazepam , Nitrazepam, Lorazepam, Oxazepam etc also deals with drugs of alcohol class.
reference should be take from Med Chem by Algarswamy , Organic Chemistry by Robert Neilson Boyd and Robert Thornton Morrison or any other suitable reference book.
This document discusses sedative-hypnotic drugs. It notes that this drug classification is based on clinical uses of sedation and encouraging sleep rather than chemical structure. Common sedative-hypnotic drugs include benzodiazepines, barbiturates, and newer nonbenzodiazepine hypnotics like zolpidem, zaleplon, and eszopiclone. These drugs work by enhancing the effects of the inhibitory neurotransmitter GABA at GABA receptors in the brain. Their clinical uses include treatment of anxiety, insomnia, and as sedatives for medical and surgical procedures.
Discovery of Drug and Introduction to Clinical Trial__Katalyst HLSKatalyst HLS
This document provides an overview of the drug discovery and clinical trials process. It discusses the goals of drug discovery which include identifying new chemical entities and developing medicines to address unmet medical needs. The drug discovery process involves target identification, validation, lead generation, and optimization. Pre-clinical testing is then conducted to evaluate safety and effects. If successful, an investigational new drug application is filed with the FDA prior to beginning clinical trials. Clinical trials involve 4 phases to test safety and efficacy in humans. Upon completion, a new drug application can be filed for FDA review and potential approval.
Pre-clinical and clinical trials are processes used to test drugs and medical devices for safety and efficacy before human use. Pre-clinical trials involve basic research and testing in animals. If promising, an Investigational New Drug application is filed with the FDA to begin clinical trials with humans. Clinical trials are conducted in phases, starting with small safety trials and progressing to large efficacy trials. If successful, final approval is sought from the FDA through a New Drug Application. The entire drug development process from basic research to approval typically takes 12-15 years and costs $100-800 million per drug.
Overview regulatory environment in usa,europe,indiashabana parveen
The document summarizes the process for clinical research and drug approval by the FDA. It describes the multi-step process including pre-clinical research in animals, Phase 1-3 clinical trials in humans to test safety and efficacy, and the submission of a New Drug Application. The FDA rigorously reviews data at each stage before approving progression to the next stage to ensure safety. The overall process aims to establish that new drugs are safe and effective for use by the American public.
The document discusses the complex process of drug development from initial discovery through clinical trials and regulatory approval. It involves several key stages: drug discovery, preclinical testing for safety and efficacy, submission of an investigational new drug application to the FDA, followed by four phases of clinical trials on humans to test for safety, efficacy, side effects and effectiveness. If successful, the drug can then be approved for marketing. However, it continues to be monitored post-approval for side effects or issues that could lead to withdrawal from the market. The entire process takes 5-10 years and billions of dollars.
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
Unit 5: Clinical trials & Regulatory guidelinesAshok Kumar
Clinical trials involve testing new medical treatments in human subjects to evaluate safety and efficacy. They are conducted in phases, with phase I trials testing safety in small groups, phase II evaluating effectiveness in larger groups, and phase III confirming effectiveness in large populations. Regulatory agencies like the FDA provide oversight of clinical trials to protect participants and ensure scientific validity. Regulatory affairs professionals play a key role in navigating regulatory requirements and maintaining compliance throughout the drug development and approval process. Their work is crucial for bringing new treatments to market and advancing medical knowledge.
The document discusses various topics related to new drug development and pharmacogenomics. It covers the stages of new drug development including drug discovery, pre-clinical research, clinical trials, FDA review and post-marketing monitoring. It also discusses pharmacogenomics and how genetic factors can influence individual responses to drugs. Key aspects like drug screening, clinical trial phases, reasons for drug failure, and the role of animal models in pre-clinical research are summarized.
The document summarizes FDA's drug review process. Key points:
1. FDA's Center for Drug Evaluation and Research (CDER) ensures drugs marketed in the US are safe and effective. CDER reviews new drug applications but does not test drugs itself.
2. Developing a new drug involves preclinical testing, clinical trials in 3 phases with increasing number of participants, and submitting a New Drug Application for FDA review.
3. The FDA review process evaluates whether clinical trials demonstrate a drug's safety and effectiveness for its intended use. If approved, the FDA continues monitoring the drug for safety after market.
With this new guidance, Dalton Pharma is committed to meeting the FDA's expectations in the development of botanical drugs, while also advancing the science of botanical medicine and improving patient outcomes. We believe that this guidance will set a new standard in the industry and help pave the way for safe and effective botanical medicines.
Stay tuned as we continue to lead the way in the botanical medicine space and provide the latest updates on our journey to better health for all.
Key areas in this whitepaper:
Botanical Drug Guidance, Purpose & Content; Regulations of Botanical Products as Drugs;
OTC monographing of Botanical drugs; Safety and efficacy required for OTC monograph inclusion; Approved Botanical Drugs; Phase 1, 2, 3 & IND Content Requirements; NDA data requirements for botanical drugs; Barriers to Botanical Drugs and NDA submissions & Approvals.
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals...Paul Below
This document provides an overview of key differences between pharmaceutical and medical device clinical research. It defines drugs and devices, compares their regulatory pathways, and reviews requirements for investigational applications and marketing approval. Major differences discussed include mechanism of action, industry environment, product development timelines, clinical study design, and sponsor and investigator responsibilities. The goal is to help those working between the pharmaceutical and device industries understand the distinctions.
This document defines important terminology used in clinical research. It includes definitions for terms like adverse reaction, arm, blinded study, investigator, monitor, protocol, randomization, sponsor, among others. The definitions provide brief explanations of the key concepts and roles involved in planning and conducting clinical trials.
Basics of Drug Discovery and DevelopmentJhony Sheik
The document outlines the process of drug discovery and development from initial screening of chemicals to determine biological activity through clinical trials and regulatory approval. It notes that of 10,000 initially screened chemicals, only 1 may reach the market place due to the high costs, risks and regulatory hurdles. The key stages discussed are preclinical testing in animals, filing an Investigational New Drug application for human trials, conducting clinical trials in four phases, filing a New Drug Application providing trial results for regulatory review and approval, large-scale manufacturing, and filing an Abbreviated New Drug Application for generic approvals relying on previously approved drugs.
ACRI is a leading clinical research training institute in Bangalore.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
ACRI is a leading clinical research training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
Pharmacology/Toxicology information to submit an IND for an anticancer drugshabeel pn
This document provides guidance on submitting preclinical pharmacology and toxicology information to support an Investigational New Drug (IND) application for an anticancer drug. It discusses the regulatory requirements for nonclinical studies evaluating safety, pharmacokinetics, and dose selection to estimate a safe starting dose for clinical trials in humans. Key areas addressed include common toxicology study types, good laboratory practice standards, resources for guidance, and planning considerations for the development program.
The document outlines the various stages involved in the new drug discovery and development process, including target identification, validation and screening, lead identification and optimization, preclinical and clinical testing through four phases, regulatory approval, and post-marketing surveillance. It notes that it takes on average 12-15 years and $900 million to $2 billion to develop a new drug, with only one in 5,000-10,000 compounds ultimately being approved due to the high failure rate of drug candidates.
Similar to Pjk abuse liability screening 02 aug-12 (20)
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Giloy in Ayurveda - Classical Categorization and SynonymsPlanet Ayurveda
Giloy, also known as Guduchi or Amrita in classical Ayurvedic texts, is a revered herb renowned for its myriad health benefits. It is categorized as a Rasayana, meaning it has rejuvenating properties that enhance vitality and longevity. Giloy is celebrated for its ability to boost the immune system, detoxify the body, and promote overall wellness. Its anti-inflammatory, antipyretic, and antioxidant properties make it a staple in managing conditions like fever, diabetes, and stress. The versatility and efficacy of Giloy in supporting health naturally highlight its importance in Ayurveda. At Planet Ayurveda, we provide a comprehensive range of health services and 100% herbal supplements that harness the power of natural ingredients like Giloy. Our products are globally available and affordable, ensuring that everyone can benefit from the ancient wisdom of Ayurveda. If you or your loved ones are dealing with health issues, contact Planet Ayurveda at 01725214040 to book an online video consultation with our professional doctors. Let us help you achieve optimal health and wellness naturally.
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
“Psychiatry and the Humanities”: An Innovative Course at the University of Mo...Université de Montréal
“Psychiatry and the Humanities”: An Innovative Course at the University of Montreal Expanding the medical model to embrace the humanities. Link: https://www.psychiatrictimes.com/view/-psychiatry-and-the-humanities-an-innovative-course-at-the-university-of-montreal
Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
GASTROINTESTINAL INFECTIONS AND GASTRITIS
Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
1. Understanding FDA Mandated Animal
Behavioral Pharmacology Screening
Paul J. Kruzich, Ph.D.
Principal Consultant
Preclinical Consulting Services, LLC
pkruzich@yahoo.com
3. What is “Abuse Potential?”
Abuse potential *when a drug is used in nonmedical
situations, repeatedly or even sporadically, for the positive
psychoactive effects it produces, it is characterized as
“abuse potential”.
*Draft Guidance for Industry Assessment of Abuse Potential of Drugs prepared
by the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and
Research (CDER) at the Food and Drug Administration
Preclinical Consulting Services, LLC
4. Common Characteristics of
Abused Drugs*
Central nervous system (CNS) activity, including:
sedation
euphoria
perceptual and other cognitive distortions
hallucinations
mood changes
Drugs with abuse potential often (but not always)
produce psychic or physical dependence and may lead
to the disorder of addiction.
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*Excerpted from Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep.
No. 91-1444, 91st Cong., Sess. 1 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4603.
5. How does the FDA Classify Drugs as
“Abuse Liable?”
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6. Factors Leading to Labeling a Drug
“Abuse Liable”
Under 21 U.S.C. 811(b) of the Controlled Substances
Act (CSA), the Secretary of Health and Human
Services is required to consider, in a scientific and
medical evaluation, 8 factors determinative of control
under the CSA.
Following consideration of the 8 factors, the Secretary
must make 3 findings and a recommendation for
scheduling a substance in the CSA.
Excerpted from the Draft Guidance for Industry Assessment of Abuse Potential of Drugs
Preclinical Consulting Services, LLC
7. The 8 factors of 21 U.S.C. 811(c)
1. The drug’s actual or relative potential for abuse
2. Scientific evidence of the drug's pharmacological
effects
3. The state of current scientific knowledge regarding
the drug or similar substances (e.g.,
class/mechanism of action)
4. The drug’s history and current pattern of abuse
Excerpted from the Draft Guidance for Industry Assessment of Abuse Potential of Drugs
Preclinical Consulting Services, LLC
8. The 8 factors (cont.)
5. The scope, duration, and significance of abuse
6. What, if any, risk there is to the public health
7. The drug’s psychic or physiological dependence
liability
8. Whether the substance is an immediate precursor of
a substance already controlled.
Excerpted from the Draft Guidance for Industry Assessment of Abuse Potential of Drugs
Preclinical Consulting Services, LLC
9. A Sponsor’s Mandate
If the drug has a potential for abuse, the sponsor must
submit “a description and analysis of studies or
information related to abuse of the drug, including a
proposal for scheduling, under the Controlled
Substances Act.” (21 CFR 314.50(d)(5)(vii)).
A description must be submitted “of any studies
related to overdosage, etc. including information on
antidotes, or other treatments, if known” (id.) in the
new drug application (NDA).
Excerpted from the Draft Guidance for Industry Assessment of Abuse Potential of Drugs
Preclinical Consulting Services, LLC
10. When Should an Abuse Potential
Assessment Be Submitted to FDA?
A sponsor must submit in the NDA an assessment of
studies and other information related to the potential
abuse of a drug when:
the drug affects the central nervous system (CNS)
the drug is chemically or pharmacologically similar to
other abused drugs
the new drug produces psychoactive effects such as
sedation, euphoria, and mood changes.
Excerpted from the Draft Guidance for Industry Assessment of Abuse Potential of Drugs
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11. When Should an Abuse Potential
Assessment be Submitted to FDA? (cont.)
An assessment of abuse potential may be needed for
new (novel) drugs, including new molecular entities
(NME).
For a marketed drug product that presents an
unexpected adverse event profile that includes events
that are related to abuse potential or that is being re-
evaluated for a new route of administration that could
affect the abuse potential of the drug.
Excerpted from the Draft Guidance for Industry Assessment of Abuse Potential of Drugs
Preclinical Consulting Services, LLC
12. What Should be Included in an
Abuse Potential Submission?
A summary, interpretation, and discussion of abuse
potential data provided in the NDA
A proposal and rationale for placing (or not placing) a
drug into a particular schedule of the Controlled
Substances Act
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13. What Should Be Included in an Abuse
Potential Submission? (cont.)
All primary data related to the abuse potential
characterization of the drug, organized under the following
subheadings:
Chemistry
Preclinical Pharmacology
Animal Behavioral and Dependence Pharmacology
Pharmacokinetics/Pharmacodynamics
Human Abuse Potential Laboratory Studies
Clinical Trial Data Relative to Abuse and Dependence Potential
Integrated Summaries of Safety and Efficacy
Foreign Experience with the Drug (Adverse Events, Abuse Potential,
Marketing, and Labeling)
Excerpted from the Draft Guidance for Industry Assessment of Abuse Potential of Drugs
Preclinical Consulting Services, LLC
14. What Should Be Included in an Abuse
Potential Submission? (cont.)
All primary data related to the abuse potential
characterization of the drug, organized under the following
subheadings: Animal Abuse
Chemistry Liability
Preclinical Pharmacology Screening!
Animal Behavioral and Dependence Pharmacology
Pharmacokinetics/Pharmacodynamics
Human Abuse Potential Laboratory Studies
Clinical Trial Data Relative to Abuse and Dependence
Potential
Integrated Summaries of Safety and Efficacy
Foreign Experience with the Drug (Adverse Events, Abuse
Potential, Marketing and Labeling)
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15. Animal Behavioral Pharmacology for
Abuse Screening
Drug Discrimination
Self-administration
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16. Drug Discrimination
Provides a behavioral indication of a drug’s
pharmacological mechanism of action in an intact
animal (usually rats or nonhuman primates)
It does not specifically provide an index of whether or
not a drug will be abused. Rather, it provides an
indication of whether or not it’s pharmacological
actions are similar to other “reference” abused drugs
See Carter and Griffiths 2009 and Mansback et al 2003
for excellent reviews
Preclinical Consulting Services, LLC
17. Drug Discrimination Procedures
Animals are trained to discriminate between a reference drug that creates a
change in internal state (e.g., amphetamine—the reference drug should have a
similar mechanism of action or chemistry as the novel compound) and an inert
vehicle (e.g., saline) in an operant task
“Motivated” (food or water restricted) animals are trained to press levers to
receive a “reward” (a tasty food pellet or fruit juice)
A computer tracks the number of responses made and rewards earned
Following lever training, animals are then administered the reference drug and
trained to press “Lever A” in order to receive a reward—several rewards can be
earned during a session
Responding of “Lever B” (saline) results in no reward
The next session/day animals are administered an inert vehicle and trained to
press “Lever B” in an operant chamber in order to receive a reward
Pressing “Lever A” on a saline day results in no reward
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19. Depiction of Inside wall of Drug Discrimination
(operant) Chamber (what the animal sees)
Pellet
Dispenser
Tube
Drug Saline
Lever A Lever B
Pellet being dropped
Food pellet reward from dispenser/hopper
in dispenser dish into dish
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20. Drug Discrimination Procedures (cont.)
Over days, the number of accurate lever presses necessary
to receive the “reward” is increased to ensure accuracy
The animal administered the reference drug must press Lever
A 10 times in a row and avoid pressing Lever B during the 10
consecutive responses
The increased requirement serves as an index of specificity/accuracy
Once the animal has demonstrated accurate discrimination
between the reference drug and saline, testing is initiated
with the novel compound.
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21. Drug Discrimination Procedures (cont.)
During testing, the animal is administered the novel compound
Based on its response pattern, the animal “tells” the researcher
whether the novel compound is similar to the reference
compound or inert vehicle (there is no “correct” or “incorrect”
response).
The animal does this by responding on the “drug” or “vehicle” lever—
either lever will deliver a reward during a “test” session.
If the novel compound induces a similar internal “cue” or
interoceptive effect that is similar to the reference drug (the
animal responds on the “drug” lever) the novel compound must
be considered “abuse liable.”
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22. Self-Administration
Rodents and nonhuman primates will self-administer
most drugs of abuse that humans self-administer (see
O'Connor et al 2011 for excellent review)
Animals (typically rats, occasionally nonhuman
primates) are implanted with indwelling intravenous
catheters
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24. Depiction of Inside wall of self-administration(operant)
chamber (what the animal sees)
Drug
Lever
Stimulus Light
(to signal when
an infusion is
occurring)
Preclinical Consulting Services, LLC
25. Self-Administration (cont.)
Through behavioral techniques, animals are trained to
self-administer (lever press/remotely administer)
several intravenous infusions of a reference drug of
abuse (e.g., amphetamine) during daily sessions
The number of allowable infusions (to protect from overdose,
self-administered infusions are controlled and recorded by a
computer)
The reference drug should be in the same class or have
a similar mechanism of action as the novel compound
(based on established pharmacology and chemistry)
Preclinical Consulting Services, LLC
26. Self-administration (cont.)
Once the animal is reliably self-administering the reference drug (based on
established criteria), the reference drug is removed from the infusion syringes
and replaced with saline the next day
Animals will not self-administer saline
After a day of saline access, the animals are given access to the training
drug again the next day
After several alternating daily reference drug/saline sessions, very reliable and
robust patterns of behavior will occur:
When the syringe is loaded with the reference drug, animals will show
good response for drug (e.g., make several [hundred] responses for drug)
When the syringe is loaded with saline, the animal will almost
immediately stop responding within the first minutes of a daily
saline/vehicle session (animals make significantly fewer responses
compared to drug days)
Preclinical Consulting Services, LLC
27. Self-administration (cont.)
Once reliable patterns of behavior are established, a
dose response curve is generated for the reference drug
Animals typically compensate for lower doses by self-
administering more infusions; doses higher than the
training doses are self-administered, but fewer
administrations are taken per session
This dose-response pattern has been describe as an “inverted
U” (Koob 2003)
If the dose is too low, experienced animals will not self-
administer that particular dose, much like saline
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28. Self-administration (cont.)
Once the complete dose response curve of the reference
drug is generated, novel compound screening occurs:
Different doses of the novel compound are provided to
animals on “test” days
Test days are interspersed between normal reference drug and
saline days
If the experimental animal self-administers the novel
compound based on a previously determined set of criteria,
the compound is considered “abuse liable.”
Preclinical Consulting Services, LLC
29. Bibliography
1. American Academy of Pain Medicine, American Pain Society and American Society of Addiction Medicine
Consensus Document. Definitions related to the use of opioids for the treatment of pain, 2001.
http//www.painmed.org/pdf/definition.pdf.
2. Carter LP, Griffiths RR. Principles of laboratory assessment of drug abuse liability and implications for
clinical development. Drug Alcohol Depend. 2009 Dec 1;105 Suppl 1:S14-25. (http://bit.ly/fK1d0y)
3. Controlled Substances Act (CSA), as amended February 15, 1996 (21 U.S.C. 801 et seq.).
(http://www.justice.gov/dea/pubs/csa.html)
4. Draft Guidance for Industry Assessment of Abuse Potential of Drugs prepared by the Controlled
Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug
Administration.
(www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198650.pd
f)
5. Koob GF (2003) Drug Reward and Addiction. In Fundamental Neuroscience (2nd Ed) Academic Press;
San Diego, CA
6. Mansbach RS, Feltner DE, Gold LH, Schnoll SH. Incorporating the assessment of abuse liability into the
drug discovery and development process. Drug Alcohol Depend. 2003;70:S73–85. (http://bit.ly/gHo0uV)
7. O'Connor EC, Chapman K, Butler P, Mead AN. The predictive validity of the rat self-administration model
for abuse liability. Neurosci Biobehav Rev. 2011;35(3):912-38.
(http://dx.doi.org/10.1016/j.neubiorev.2010.10.012)
Preclinical Consulting Services, LLC
30. Contact Information
Paul J. Kruzich, Ph.D.
Principal Consultant
Preclinical Consulting Services, LLC
pkruzich@yahoo.com