What is in a Drug Test
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Awareness about safety working condition and to lessen the impact of Drug Abuse in work place gives rise to growing drug tests conducted by Employers nowadays. Depending on the type of job, illicit drug use can impact job performance and the lives of other people
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Clinical research management slide
This presentation discusses various topics related to clinical research management including:
- Preparation of clinical studies according to ICH guidelines.
- The difference between audits and inspections, who conducts them, and what they audit.
- Monitoring clinical studies to ensure adherence to protocols, SOPs, and regulations.
- Pharmacovigilance including adverse event reporting procedures.
- Documentation requirements for clinical research.
- Budgeting considerations for clinical trials including personnel, technology, data management.
- Vendor management activities like contracting, governance, and relationship management.
BioEntrepreneurship: Navigating the Global Regulatory Pathway
Speaker: Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc.
Topics Addressed
* Planning ahead to add credibility and value with your partners, investors and outside experts
* What is the landscape of various filings for a drug, a medical device or a diagnostic device?
* Developing a multi-disciplinary project team to manage your regulatory strategy:
o Different strategies for different products
o How to formulate a sound path to drug development decision-making
* What is needed for approval of a medical device
* The preclinical studies required for an IND filing
* The multiple components of the actual IND submission
* Management and communication between the teams assembling the IND
o When to outsource and bring in consultants
* Interacting with the regulatory authority
Download an audio file of this presentation at:
http://www.marsdd.com/bioent/jan15
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The document discusses generic drug performance and quality in Pakistan. It notes that while generic drugs can significantly lower drug prices, they must demonstrate the same therapeutic effects as innovator drugs. Ensuring drug quality is complex and requires integrated multidisciplinary approaches. The drug regulatory authority of Pakistan (DRAP) is approving many generic drug applications but faces questions about the quality of the drugs it supervises due to limited resources and testing capabilities compared to agencies like the US FDA. Improving post-marketing quality surveillance and compliance with good manufacturing practices is important to ensure drug safety and availability.
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014
This document summarizes a report from Health Canada on drug GMP inspections conducted in fiscal year 2013-2014. Some key details include:
- 428 domestic drug GMP inspections were conducted and 411 received compliant ratings. 13 foreign inspections and 12 were compliant.
- The most frequently cited regulatory sections were for quality control, manufacturing control, and records requirements.
- Most observations (99%) were rated Risk 2 or 3 in terms of potential risk to patients.
- Key priorities for the program in 2014-2015 include enhancing risk management and collaborating with international partners.
Analysis of raw materials
This file describes analysis of raw material in pharmaceutical and contain different steps which is to be followed for its analysis
Indusrty and Fda liasions
The document discusses industry and FDA liaisons. It describes the FDA's mission to protect public health by regulating food, drugs, and other products. The FDA has 9,000 employees who monitor over $1 trillion worth of products annually. The FDA ensures product safety through inspections, legal sanctions for noncompliance, and scientific review. Industry can communicate with the FDA through various divisions and meetings to facilitate product development and approval processes.
Drug development
This document discusses the process of drug development from sources and discovery through clinical trials and regulatory approval. Key points covered include preclinical research involving animal studies to assess toxicity and efficacy. Clinical trials have four phases from initial small human studies to large trials to confirm safety and effectiveness. New drug applications are submitted to regulatory agencies like the FDA for review and approval before marketing. Ongoing monitoring occurs after approval to identify any rare or long-term adverse effects.
Regulatory requirements for drug approval
B. Pharm. Final Year, Sem:- VII, INDUSTRIAL PHARMACY-II,
Unit 3 chapter 4 Regulatory requirements for drug approval,
As per PCI Syllabus
HR ProFile Drug TestingWith WithOUT Pricing
HR ProFile offers a full range of drug testing services through their partnership with LabCorp, a certified testing provider. They provide options for urine, hair, saliva, and alcohol drug testing with various panel options from 5-panel to 12-panel tests. Their services include in-network and third-party specimen collection, medical review of all results, and electronic or standard chain of custody protocols. HR ProFile has over 20 years of experience providing background checks, drug testing, and other human resource screening solutions to clients nationally and internationally.
OUTSOURCING TO BE AND BA final (1).pptx
This document discusses outsourcing bioavailability and bioequivalence studies to contract research organizations (CROs). It covers key considerations for identifying an appropriate CRO, including assessing their clinical, bioanalytical, and pharmacokinetic capabilities. The document also discusses important factors for qualifying CRO clinical and bioanalytical sites, such as personnel qualifications and compliance with good clinical and laboratory practices. Additionally, it addresses protocol development, clinical study population selection, laboratory tests, dose and safety considerations, and bioanalytical method validation.
Drug design and development
The document summarizes key aspects of drug design, discovery, and development processes. It discusses identifying a disease target, finding a lead compound, preclinical testing involving formulation and animal studies, conducting human clinical trials for approval, and scaling up manufacturing. Computer-aided drug design and in silico methods like molecular docking are described which use computer modeling to facilitate drug discovery. Challenges in drug development like permeability, stability, solubility are highlighted. The lengthy and expensive nature of developing a new drug taking 15-16 years and costing $880 million on average is also noted.
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- 2. 2 What is Drug Test? A “drug test” is a technical analysis of a biological specimen – for example urine, hair, sweat, blood or saliva – to determine the presence or absence of specified parent drugs or their metabolites. Major uses of drug testing are to detect the presence of drugs prohibited by laws, such as cannabis, cocaine, marijuana and heroin.
- 3. 3 Why it is Conducted? Drug test is conducted to evaluate whether any candidate is addicted to any of the drugs prohibited by laws. Drug testing has become an important safety issue in the workplace for Human Resources and Safety professionals. A large percentage of Fortune 500 companies perform drug testing. The purpose is to lessen the impact from drug abuse in the workplace, including tardiness, absenteeism, attitude problems, theft, decreased productivity, crime and violence. Clients will normally request Matrix to conduct drug test to their candidates who are involved in special projects.
- 4. 4 What is Tested? Most employers utilize a standard five-panel test of "street drugs," Some employer’s use seven or ten-panel test, which includes prescription drugs that are legal to possess and use. Panel-wise Drug Test 5 Panel Drug Test 7 Panel Drug Test 10 Panel Drug Test AMPHETAMINES AMPHETAMINES MARIJUANA METABOLITES COCAINE METABOLITES BARBITURATES COCAINE METABOLITES MARIJUANA METABOLITES COCAINE METABOLITES AMPHETAMINES PHENCYCLIDINE MARIJUANA METABOLITES PCP OPIATES OPIATES OPIATES / METABOLITES - PHENCYCLIDINE BARIBITURATES - PROPOXYPHENE BENZODIAZEPINES - - PROPOXYPHENE - - METHADONE - - METHAQUALONE
- 5. 5 How it is Conducted? The Urine Sample are collected for drug test by using any one of the below modes as per the client’s request and sent to Laboratory for testing. Lab Technician should visit the client company’s address on an appointed date / time where the newly joined employees are gathered and he / she collects the samples. Client sends the employee to a collection site on an appointed date / time, where the sample is obtained. Results are normally shared by Laboratories within 3 to 4 working days.
- 6. LinkedIn: kameswarankc Pininterest: thinkpro Twitter: kameshwerkc