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Basics For Pharma

Include the basic knowledge of several fields like pharmacology, microbiology, virology etc. A pharma professional must carry the basics of these fields in order to face the challenges in daily encounters with medical practitioner.

Basic Pharmacology

Post By: Hussainz Posted Date: January 1, 2012

Pharmacy

It deals with preparing, compounding, dispensing, and proper utilization of medical drugs. It links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of Pharmaceutical Drugs. The field of Pharmacy can generally be divided into four primary disciplines:
Pharmaceutics
Pharmacognosy
Pharmacy Practice
Pharmacology

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Routes of Administration of Drugs

Post By: Hussainz Posted Date: January 1, 2012

Routes of Administration

The route of administration is defined as the path by which a drug or other substance enters the body. The pharmacokinetic properties, such as absorption, distribution, metabolism, and excretion, of a drug are critically influenced by the route of administration.

Routes of administration can broadly be divided into four categories: Topical, Enteral, Parenteral and other.

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Dosage Forms

Post By: Hussainz Posted Date: October 24, 2012

Dosage forms are the means by which drug molecules are delivered to sites of action within the body. The different forms in which drugs may be supplied to a patient are:
    Oral drugs
    Inhalational agents
    Topical agents
    Suppository
    Parenteral Injections

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Prescription Abbreviations

Post By: Hussainz Posted Date: December 17, 2011

Prescription Abbreviations

  • μg     microgram
  • 1/2NS   half normal saline (0.45%) 
  • a.c.    ante cibum - before meals
  • a.d.   auris dextra - right ear
  • a.l., a.s.   auris laeva, auris sinistra - left ear
  • a.m.   ante meridiem - morning, before noon
  • A.T.C.   around the clock
  • a.u.   auris utraque - both ears
  • aa     ana - of eachad ad - up to
  • ad lib.   ad libitum - use as much as one desires;  freely
  • admov.   admove - apply
  • agit agita   stir/shake
  • alt. h.   alternis horis - every other hour
  • aq     aqua - water

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Infectious Diseases

Post By: Hussainz Posted Date: October 23, 2012

INFECTION
An infection is a pathological condition which results from the invasion of the body by pathogenic microorganisms. The immune system either fails to recognize or is incapable of responding to in an effective manner. Pathogens can cause severe consequences due to:

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Antibiotics

Post By: Hussainz Posted Date: February 11, 2012

These drugs are used to treat infections caused by bacteria. The word antibiotic comes from the Greek anti meaning 'against' and bios meaning 'life' (a bacterium is a life form). Antibiotics are also known as antibacterials.

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Antiviral Drugs

Post By: Hussainz Posted Date: May 22, 2012

Antiviral drugs are a class of antimicrobials used specifically for treating viral infections. They are relatively harmless to host because they inhibit the development of pathogens instead of destroying them. Most of the antiviral agents need to be activated by viral and cellular enzymes before exerting antiviral effect. Hence, activity of enzymes and concentration of substrates will influence the efficacy of these drugs.

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Vaccines

Post By: Hussainz Posted Date: March 7, 2012

Vaccines are used to prevent infection by elevating immunological sensitivity to potential pathogens. Attenuated (significantly less dangerous) versions of infectious agents are used to enhance the natural immune response typically through injection or oral ingestion.

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Epidemiology

Post By: Hussainz Posted Date: January 1, 2012

Epidemiology is the study of public health, or more specifically, the study of health and disease conditions in specific populations. It is the basic science of preventive and social medicine.

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Nutrition

Post By: Hussainz Posted Date: February 2, 2012

Nutrition is the process of taking in and utilizing food to gain energy. There are six types of nutrients:
    Proteins
    Carbohydrates
    Fats
    Vitamins
    Minerals
    Water

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Nutraceuticals

Post By: Hussainz Posted Date: March 11, 2012

Nutraceutical Concept

  • A nutraceutical is any food or food-ingredient considered to provide medical or health benefits (including prevention and treatment of disease).
  • The market for nutraceuticals is rapidly growing worldwide.
  • It is estimated that $250 billion, (50% of the U.S. food market of $503 billion), may be attributable to nutraceuticals (if including dietary supplements, sugar substitutes, fat substitutes, fiber-enriched foods, vegetables, fatless meat, skim milk, low-calorie diets).

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Salary Negotiation

Post By: Hussainz Posted Date: January 1, 2012

Some Important Tips an Individual should Keep in Mind during Salary Negotiation:

Always remember that the organization also needs you as much as you need the job. There is always a dearth of talented people. The organizations are also in search of best talents and if you have the calibre and skills, you will definitely be paid a handsome salary. If you have reached the salary negotiation round, which in all probable cases is the last round, the company officials must have seen a spark in you. No need to panic or get nervous. Just be yourself and relax. Take care of your posture as well. Sit straight and make an eye contact with the person sitting on the other side of the table. Look confident and smart.Don’t assume that you will just cook stories and the HR would trust you. Be specific and clear in your communication. Don’t try to confuse the other person.

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SOP Regulatory Affairs

Post By: Hussainz Posted Date: January 1, 2012

Introduction

Regulatory Affairs in pharmaceuticals (RA in pharma), also known as Government Affairs( Pharmaceutical regulatory affairs in pharmaceutical industry), this field in pharmaceutical industry is dealing with all aspects of government affairs , submitting products, getting license and registration of pharmaceutical products for sale and everything. Regulatory affairs departments are there in most of the regulated industries, like pharmaceuticals industry, medical devices, energy, and banking.

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Etiquette

Post By: Hussainz Posted Date: January 1, 2012

Etiquette in simpler words is defined as good behaviour which distinguishes human beings from animals. Human Being is a social animal and it is really important for him to behave in an appropriate way. Etiquette refers to behaving in a socially responsible way.

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Quality Risk Management (Brief)

Post By: Hussainz Posted Date: June 11, 2012

Quality Risk Management
Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

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Corrective and Preventive Action for Pharmaceutical Industry (CAPA)

Post By: Hussainz Posted Date: June 17, 2012

CAPA is a fundamental management tool that should be used in every quality system.

Corrective Actions
A corrective action is a term that encompasses the process of reacting to product problems, customer complaints or other nonconformities and fixing them. The process includes:

  • Reviewing and defining the problem or nonconformity.
  • Finding the cause of the problem.
  • Developing an action plan to correct the problem and prevent a recurrence.
  • Implementing the plan.
  • Evaluating the effectiveness of the correction.

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Risk Evaluation and Mitigation Strategies (REMS)

Post By: Hussainz Posted Date: July 6, 2012

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS.

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GMP

Post By: Hussainz Posted Date: July 26, 2012

GMP:
That part of Quality Assurance which ensures that products are consistently
produced and controlled to the quality standards appropriate to their intended use
and as required by the Marketing Authorisation or product specification.

Quality Assuranc:
The sum total of the organised arrangements made with the object of ensuring that
medicinal products are of the quality required for their intended use.
The formal definition of Quality is:
“The totality of features and characteristics of a product or service which bear on its
ability to meet stated or implied needs”.

The aim of GMP is to build quality into the product (and the service). The control of
quality begins long before we collect any blood, in activities such as designing
buildings, specifying equipment, defining procedures and so on.

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Diffference between Out of Specification (OOS) and Out of Trend (OOT)

Post By: Hussainz Posted Date: May 23, 2013

1.     1- OOS (out of specification) is the comparison of one result versus predetermined specification criteria while OOT (out of trend) is the comparison of many historical data values versus time.

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Pharmaceutical Waters

Post By: Hussainz Posted Date: May 27, 2013

Water is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceuticals products, active pharmaceutical ingredients (APIs) and intermediates, compendial articles, and analytical reagents. The United States Pharmacopeia (USP) defines several type of water including: Purified Water, Water for Injection, Sterile Purified Water, Sterile Water for Injection, Sterile Bacteriostatic Water for Injection, Sterile water for Inhalation, Sterile water for hemodialysis,  and Sterile water for irrigation.

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